Trial Outcomes & Findings for To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (NCT NCT03544281)
NCT ID: NCT03544281
Last Updated: 2025-03-18
Results Overview
DLT is an adverse event (AE) that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 28 day DLT period and meets at least one of the DLT criteria: Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment; Grade 4 thrombocytopenia \<25,000/mm\^3 accompanied by significant bleeding; any Grade 3 or greater non-hematologic laboratory value (if laboratory abnormality persist \>48 h despite supportive treatment or abnormality leading to hospitalisation); non-hematologic toxicity which does not resolve with appropriate supportive treatment within 48 h, Grade 4 corneal adverse events; and other organ specific toxicities (liver toxicity that causes discontinuation of treatment).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
153 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2025-03-18
Participant Flow
The study consisted of two phases - Main Study Phase (Day 1 to Month 53) and Post Analysis Continued Treatment (PACT) Phase (From Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants). In PACT phase those participants still benefiting from drug continued to receive study drug until discontinued or withdrawn from study.
Participant milestones
| Measure |
PACT Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle until PD, death, intolerable toxicity, or consent withdrawn.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
PACT Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle until PD, death, intolerable toxicity, or consent withdrawn.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
PACT Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 1.9 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 1.9 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 2.5 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 2.5 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 2.5 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 3.4 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Main Study Phase
STARTED
|
0
|
13
|
12
|
13
|
18
|
12
|
16
|
0
|
12
|
4
|
13
|
16
|
12
|
12
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study Phase
All Treated
|
0
|
12
|
12
|
13
|
18
|
12
|
16
|
0
|
12
|
4
|
13
|
16
|
12
|
12
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study Phase
DLT-evaluable
|
0
|
0
|
0
|
0
|
6
|
0
|
7
|
0
|
0
|
3
|
4
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study Phase
COMPLETED
|
0
|
4
|
6
|
4
|
4
|
4
|
8
|
0
|
4
|
1
|
4
|
2
|
6
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study Phase
NOT COMPLETED
|
0
|
9
|
6
|
9
|
14
|
8
|
8
|
0
|
8
|
3
|
9
|
14
|
6
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PACT Phase
STARTED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
4
|
2
|
4
|
4
|
2
|
2
|
1
|
|
PACT Phase
COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
4
|
2
|
3
|
3
|
2
|
2
|
1
|
|
PACT Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
PACT Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle until PD, death, intolerable toxicity, or consent withdrawn.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
PACT Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle until PD, death, intolerable toxicity, or consent withdrawn.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
PACT Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 1.9 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 1.9 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 2.5 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 2.5 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 2.5 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 3.4 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Main Study Phase
Death
|
0
|
4
|
5
|
5
|
8
|
6
|
4
|
0
|
3
|
2
|
6
|
8
|
4
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study Phase
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study Phase
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study Phase
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
3
|
0
|
4
|
0
|
2
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study Phase
Ongoing
|
0
|
4
|
0
|
2
|
2
|
1
|
0
|
0
|
3
|
1
|
2
|
4
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study Phase
Investigator Site Closed
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study Phase
Did not receive study treatment
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PACT Phase
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
Baseline Characteristics
To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
Baseline characteristics by cohort
| Measure |
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18 to <65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
58 Participants
n=36 Participants
|
|
Age, Customized
65 to <75 years
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
67 Participants
n=36 Participants
|
|
Age, Customized
>=75 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
27 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
48 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
104 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
10 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 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
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
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
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
129 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Missing
|
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
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: DLT-evaluable population included participants who received at least 1 full dose of belantamab mafodotin and at least 75% of planned doses of Len/Dex by the end of Cycle 1 (Day 28). As pre-specified in protocol, only specified treatment arms were planned to be analyzed for DLTs.
DLT is an adverse event (AE) that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 28 day DLT period and meets at least one of the DLT criteria: Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment; Grade 4 thrombocytopenia \<25,000/mm\^3 accompanied by significant bleeding; any Grade 3 or greater non-hematologic laboratory value (if laboratory abnormality persist \>48 h despite supportive treatment or abnormality leading to hospitalisation); non-hematologic toxicity which does not resolve with appropriate supportive treatment within 48 h, Grade 4 corneal adverse events; and other organ specific toxicities (liver toxicity that causes discontinuation of treatment).
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=6 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs), Treatment A
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 21 daysPopulation: DLT-evaluable population included participants who received at least 1 full dose of belantamab mafodotin and at least 75% of planned doses of Bor/Dex by the end of Cycle 1 (Day 21). As pre-specified in protocol, only specified treatment arms were planned to be analyzed for DLTs.
DLT is an adverse event (AE) that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21 day DLT period and meets at least one of the DLT criteria: Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment; Grade 4 thrombocytopenia \<25,000/mm\^3 accompanied by significant bleeding; any Grade 3 or greater non-hematologic laboratory value (if laboratory abnormality persist \>48 h despite supportive treatment or abnormality leading to hospitalisation); non-hematologic toxicity which does not resolve with appropriate supportive treatment within 48 h, Grade 4 corneal adverse events; and other organ specific toxicities (liver toxicity that causes discontinuation of treatment).
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=6 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=7 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With DLTs, Treatment B
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 4.5 yearsPopulation: All treated population included all participants who received at least one dose of study treatment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent disability/incapacity or Is a congenital anomaly/birth defect, Other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. A summary of number of participants with any AEs and SAEs are presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AE
|
12 Participants
|
16 Participants
|
16 Participants
|
12 Participants
|
4 Participants
|
13 Participants
|
12 Participants
|
12 Participants
|
12 Participants
|
12 Participants
|
13 Participants
|
18 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAE
|
6 Participants
|
9 Participants
|
10 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
8 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 4.5 yearsPopulation: All treated population. Only those participants with data available at specified time points have been analyzed.
12-lead electrocardiogram (ECGs) were obtained using an automated ECG machine that automatically calculated the QTcF intervals. QTc values are categorized into the clinical concern ranges which are specific to changes in QTc: 31-60 milliseconds (msec), and \>60 msec, and \>530msec. An increase is defined relative to Baseline. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Data of number of participants with worst-case increase post baseline is presented.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=10 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF)
Increase of 31-60 msec
|
5 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF)
Increase of >60 msec
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF)
Increase of >530 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 4.5 yearsPopulation: All treated population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for analysis of following hematology parameters: Hemoglobin (hemoglobin increased and anemia), Lymphocytes (lymphocyte count increased and lymphocyte count decreased), Neutrophils, Platelets and Leukocytes (leukocytosis and white blood cells decreased). The laboratory parameters were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03. Grade (G) 1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Anemia, Increase to Grade 3
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Hemoglobin increased, Any Grade Increase
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Hemoglobin increased, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Hemoglobin increased, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Anemia, Any Grade Increase
|
8 Participants
|
10 Participants
|
9 Participants
|
7 Participants
|
2 Participants
|
8 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
11 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Anemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Lymphocyte count increased, Any Grade Increase
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Lymphocyte count increased, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Lymphocyte count increased, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Lymphocyte count decreased, Any Grade Increase
|
10 Participants
|
15 Participants
|
12 Participants
|
11 Participants
|
3 Participants
|
10 Participants
|
11 Participants
|
12 Participants
|
10 Participants
|
11 Participants
|
12 Participants
|
13 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Lymphocyte count decreased, Increase to Grade 3
|
3 Participants
|
8 Participants
|
4 Participants
|
7 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Lymphocyte count decreased, Increase to Grade 4
|
3 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Neutrophils, Any Grade Increase
|
8 Participants
|
9 Participants
|
9 Participants
|
8 Participants
|
3 Participants
|
9 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
10 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Neutrophils, Increase to Grade 3
|
4 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Neutrophils, Increase to Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Platelets, Any Grade Increase
|
12 Participants
|
16 Participants
|
15 Participants
|
9 Participants
|
4 Participants
|
12 Participants
|
11 Participants
|
12 Participants
|
11 Participants
|
12 Participants
|
13 Participants
|
18 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Platelets, Increase to Grade 3
|
2 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Platelets, Increase to Grade 4
|
9 Participants
|
10 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
7 Participants
|
9 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Leukocytosis, Any Grade Increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Leukocytosis, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Leukocytosis, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
White blood cell decreased, Any Grade Increase
|
8 Participants
|
13 Participants
|
8 Participants
|
10 Participants
|
3 Participants
|
11 Participants
|
5 Participants
|
8 Participants
|
3 Participants
|
7 Participants
|
8 Participants
|
11 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
White blood cell decreased, Increase to Grade 3
|
3 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
White blood cell decreased, Increase to Grade 4
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 4.5 yearsPopulation: All treated population. Only those participants with data available at specified time points have been analyzed. Participants are counted twice if the participant has values that changed "Decreased to Low" and "Increased to High", so the sum of the percentages may not add to 100% for each category.
Blood samples were collected for the analysis of following hematology parameters: basophils, eosinophils, hematocrit, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), monocytes, erythrocytes and reticulocyte. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values from baseline have been presented. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Monocytes, Increase to High
|
5 Participants
|
8 Participants
|
10 Participants
|
4 Participants
|
2 Participants
|
11 Participants
|
6 Participants
|
10 Participants
|
10 Participants
|
8 Participants
|
8 Participants
|
10 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Basophils, Decrease to Low
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Basophils, Change to Normal or No Change
|
11 Participants
|
12 Participants
|
10 Participants
|
10 Participants
|
4 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
10 Participants
|
11 Participants
|
11 Participants
|
12 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Basophils, Increase to High
|
1 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Eosinophils, Decrease to Low
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Eosinophils, Change to Normal or No Change
|
10 Participants
|
13 Participants
|
7 Participants
|
7 Participants
|
2 Participants
|
8 Participants
|
11 Participants
|
9 Participants
|
12 Participants
|
10 Participants
|
10 Participants
|
11 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Eosinophils, Increase to High
|
1 Participants
|
0 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Hematocrit, Decrease to Low
|
1 Participants
|
7 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Hematocrit, Change to Normal or No Change
|
11 Participants
|
8 Participants
|
12 Participants
|
8 Participants
|
3 Participants
|
12 Participants
|
10 Participants
|
7 Participants
|
9 Participants
|
11 Participants
|
10 Participants
|
14 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Hematocrit, Increase to High
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCH, Decrease to Low
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCH, Change to Normal or No Change
|
10 Participants
|
11 Participants
|
13 Participants
|
9 Participants
|
3 Participants
|
7 Participants
|
10 Participants
|
7 Participants
|
8 Participants
|
9 Participants
|
10 Participants
|
9 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCH, Increase to High
|
0 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCHC, Increase to High
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCV, Change to Normal or No Change
|
10 Participants
|
13 Participants
|
11 Participants
|
10 Participants
|
3 Participants
|
7 Participants
|
10 Participants
|
7 Participants
|
7 Participants
|
10 Participants
|
11 Participants
|
10 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCV, Increase to High
|
2 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Monocytes, Decrease to Low
|
3 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
8 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Monocytes, Change to Normal or No Change
|
5 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Erythrocytes, Decrease to Low
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Erythrocytes, Change to Normal or No Change
|
9 Participants
|
13 Participants
|
13 Participants
|
9 Participants
|
3 Participants
|
13 Participants
|
11 Participants
|
10 Participants
|
12 Participants
|
11 Participants
|
13 Participants
|
14 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Erythrocytes, Increase to High
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Reticulocytes, Decrease to Low
|
3 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Reticulocytes, Change to Normal or No Change
|
4 Participants
|
2 Participants
|
7 Participants
|
7 Participants
|
1 Participants
|
5 Participants
|
9 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Reticulocytes, Increase to High
|
6 Participants
|
10 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
7 Participants
|
2 Participants
|
6 Participants
|
7 Participants
|
8 Participants
|
3 Participants
|
9 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCHC, Decrease to Low
|
5 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCHC, Change to Normal or No Change
|
6 Participants
|
11 Participants
|
12 Participants
|
8 Participants
|
3 Participants
|
9 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
10 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCV, Decrease to Low
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 4.5 yearsPopulation: All treated population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for analysis of following clinical chemistry parameters: Hyperglycemia, Hypoglycemia, Albumin, Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase, (AST), Bilirubin, Creatine Kinase (CK), Creatinine, Gamma Glutamyl Transferase (GGT), Hyperkalemia, Hypokalemia, Hypermagnesemia, Hypomagnesemia, Phosphate, Hypernatremia, Hyponatremia, Urate, Hypercalcemia and Hypocalcemia. Laboratory parameters were graded according to CTCAE v4.03. Grade (G) 1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=15 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperglycemia, Any Grade Increase
|
6 Participants
|
8 Participants
|
11 Participants
|
3 Participants
|
1 Participants
|
9 Participants
|
8 Participants
|
9 Participants
|
9 Participants
|
8 Participants
|
5 Participants
|
10 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperglycemia, Increase to Grade 3
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperglycemia, Increase to Grade 4
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypoglycemia, Any Grade Increase
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypoglycemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypoglycemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Albumin, Any Grade Increase
|
5 Participants
|
8 Participants
|
9 Participants
|
6 Participants
|
2 Participants
|
8 Participants
|
5 Participants
|
8 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
14 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Albumin, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Albumin, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Alkaline Phosphatase, Any Grade Increase
|
2 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
0 Participants
|
7 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Alkaline Phosphatase, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Alkaline Phosphatase, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
ALT, Any Grade Increase
|
7 Participants
|
8 Participants
|
7 Participants
|
7 Participants
|
1 Participants
|
7 Participants
|
5 Participants
|
5 Participants
|
9 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
ALT, Increase to Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
ALT, Increase to Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
AST, Any Grade Increase
|
8 Participants
|
12 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
8 Participants
|
10 Participants
|
12 Participants
|
8 Participants
|
10 Participants
|
8 Participants
|
11 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
AST, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
AST, Increase to Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Bilirubin, Any Grade Increase
|
1 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
CK, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Creatinine, Any Grade Increase
|
1 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Creatinine, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Creatinine, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
GGT, Any Grade Increase
|
6 Participants
|
9 Participants
|
9 Participants
|
9 Participants
|
1 Participants
|
9 Participants
|
6 Participants
|
7 Participants
|
5 Participants
|
10 Participants
|
8 Participants
|
10 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
GGT, Increase to Grade 3
|
0 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
GGT, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperkalemia, Any Grade Increase
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperkalemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperkalemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypokalemia, Any Grade Increase
|
7 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
8 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypokalemia, Increase to Grade 3
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Phosphate, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Bilirubin, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypomagnesemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
CK, Any Grade Increase
|
4 Participants
|
7 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
CK, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypokalemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Phosphate, Increase to Grade 3
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypermagnesemia, Any Grade Increase
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypermagnesemia, Increase to Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypermagnesemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypomagnesemia, Any Grade Increase
|
4 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypomagnesemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Phosphate, Any Grade Increase
|
8 Participants
|
7 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
6 Participants
|
5 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypernatremia, Any Grade Increase
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypercalcemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Bilirubin, Increase to Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypernatremia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypernatremia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyponatremia, Any Grade Increase
|
2 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyponatremia, Increase to Grade 3
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyponatremia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Urate, Any Grade Increase
|
—
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
1 Participants
|
—
|
—
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Urate, Increase to Grade 3
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Urate, Increase to Grade 4
|
—
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
1 Participants
|
—
|
—
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypercalcemia, Any Grade Increase
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypercalcemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypocalcemia, Any Grade Increase
|
0 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypocalcemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypocalcemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 4.5 yearsPopulation: All treated population. Only those participants with data available at specified time points have been analyzed. Participants are counted twice if the participant has values that changed "Decreased to Low" and "Increased to High", so the sum of the percentages may not add to 100% for each category.
Blood samples were collected for analysis of following clinical chemistry parameters: Direct Bilirubin (DB), Calcium, Chloride, Carbon Dioxide (CO2), lactate dehydrogenase (LDH) and Protein. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values from baseline have been presented. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=15 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
DB, Increase to High
|
2 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
LDH, Increase to High
|
8 Participants
|
11 Participants
|
8 Participants
|
6 Participants
|
3 Participants
|
9 Participants
|
8 Participants
|
8 Participants
|
9 Participants
|
7 Participants
|
8 Participants
|
17 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Chloride, Increase to High
|
1 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
DB, Decrease to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
DB, Change to Normal or No Change
|
10 Participants
|
14 Participants
|
8 Participants
|
4 Participants
|
4 Participants
|
9 Participants
|
11 Participants
|
8 Participants
|
10 Participants
|
9 Participants
|
9 Participants
|
13 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Calcium, Decrease to Low
|
2 Participants
|
5 Participants
|
7 Participants
|
7 Participants
|
1 Participants
|
7 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
9 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Calcium, Change to Normal or No Change
|
6 Participants
|
11 Participants
|
7 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
8 Participants
|
5 Participants
|
6 Participants
|
10 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Calcium, Increase to High
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Chloride, Decrease to Low
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Chloride, Change to Normal or No Change
|
10 Participants
|
12 Participants
|
10 Participants
|
5 Participants
|
3 Participants
|
8 Participants
|
8 Participants
|
7 Participants
|
5 Participants
|
10 Participants
|
7 Participants
|
9 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
CO2, Decrease to Low
|
4 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
0 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
CO2, Change to Normal or No Change
|
8 Participants
|
11 Participants
|
7 Participants
|
7 Participants
|
4 Participants
|
7 Participants
|
5 Participants
|
7 Participants
|
9 Participants
|
8 Participants
|
6 Participants
|
14 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
CO2, Increase to High
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Protein, Decrease to Low
|
7 Participants
|
10 Participants
|
12 Participants
|
8 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
7 Participants
|
11 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Protein, Change to Normal or No Change
|
4 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
8 Participants
|
8 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Protein, Increase to High
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
LDH, Decrease to Low
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
LDH, Change to Normal or No Change
|
4 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 4.5 yearsPopulation: All treated population. Only those participants with data available at specified time points have been analyzed.
Urine samples were collected to analyze presence of occult blood and protein in urine by dipstick method. Data for worst-case post baseline urinalysis results is presented. Result for urinalysis parameters were recorded as no change/decreased and increase to trace, 1+, 2+, 3+, \>3+ indicating proportional concentrations in the urine sample. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=10 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst-case Change Post Baseline Urinalysis Results: Occult Blood and Protein
Occult Blood, Increase to 2+
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Change Post Baseline Urinalysis Results: Occult Blood and Protein
Occult Blood, Increase to 3+
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Change Post Baseline Urinalysis Results: Occult Blood and Protein
Protein, Increase to 2+
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Worst-case Change Post Baseline Urinalysis Results: Occult Blood and Protein
Protein, Increase to 3+
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Worst-case Change Post Baseline Urinalysis Results: Occult Blood and Protein
Occult Blood, Increase to TRACE
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Change Post Baseline Urinalysis Results: Occult Blood and Protein
Protein, Increase to >3+
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Change Post Baseline Urinalysis Results: Occult Blood and Protein
Occult Blood, Increase to >3+
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Change Post Baseline Urinalysis Results: Occult Blood and Protein
Protein, No Change/Decreased
|
4 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
7 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
8 Participants
|
|
Number of Participants With Worst-case Change Post Baseline Urinalysis Results: Occult Blood and Protein
Protein, Increase to TRACE
|
0 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Worst-case Change Post Baseline Urinalysis Results: Occult Blood and Protein
Protein, Increase to 1+
|
2 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Worst-case Change Post Baseline Urinalysis Results: Occult Blood and Protein
Occult Blood, No Change/Decreased
|
7 Participants
|
12 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
8 Participants
|
6 Participants
|
9 Participants
|
4 Participants
|
11 Participants
|
|
Number of Participants With Worst-case Change Post Baseline Urinalysis Results: Occult Blood and Protein
Occult Blood, Increase to 1+
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 4.5 yearsPopulation: All treated population. Only those participants with data available at specified time points have been analyzed.
Urine samples were collected to analyze urine pH levels. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=10 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Urine Potential of Hydrogen (pH)
Baseline (Day 1)
|
5.9 Potential of Hydrogen (pH)
Standard Deviation 1.18
|
5.7 Potential of Hydrogen (pH)
Standard Deviation 0.70
|
5.8 Potential of Hydrogen (pH)
Standard Deviation 0.69
|
5.9 Potential of Hydrogen (pH)
Standard Deviation 0.46
|
5.8 Potential of Hydrogen (pH)
Standard Deviation 0.65
|
6.0 Potential of Hydrogen (pH)
Standard Deviation 0.90
|
6.1 Potential of Hydrogen (pH)
Standard Deviation 0.68
|
5.8 Potential of Hydrogen (pH)
Standard Deviation 0.62
|
6.4 Potential of Hydrogen (pH)
Standard Deviation 0.87
|
5.6 Potential of Hydrogen (pH)
Standard Deviation 0.48
|
5.9 Potential of Hydrogen (pH)
Standard Deviation 0.82
|
6.1 Potential of Hydrogen (pH)
Standard Deviation 0.82
|
|
Change From Baseline in Urine Potential of Hydrogen (pH)
Change from baseline (up to approx. 4.5 years)
|
0.4 Potential of Hydrogen (pH)
Standard Deviation 0.55
|
0.2 Potential of Hydrogen (pH)
Standard Deviation 1.05
|
0.2 Potential of Hydrogen (pH)
Standard Deviation 0.29
|
0.1 Potential of Hydrogen (pH)
Standard Deviation 1.08
|
-0.2 Potential of Hydrogen (pH)
Standard Deviation 0.76
|
0.4 Potential of Hydrogen (pH)
Standard Deviation 1.38
|
-0.3 Potential of Hydrogen (pH)
Standard Deviation 0.61
|
0.6 Potential of Hydrogen (pH)
Standard Deviation 0.42
|
-0.5 Potential of Hydrogen (pH)
Standard Deviation 0.50
|
0.2 Potential of Hydrogen (pH)
Standard Deviation 0.66
|
0.4 Potential of Hydrogen (pH)
Standard Deviation 1.03
|
0.2 Potential of Hydrogen (pH)
Standard Deviation 0.80
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 4.5 yearsPopulation: All treated population. Only those participants with data available at specified time points have been analyzed.
Urine samples were collected to analyze urine specific gravity using dipstick method. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=14 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=7 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=6 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Urine Specific Gravity
Baseline (Day 1)
|
1.0174 Ratio
Standard Deviation 0.00713
|
1.0139 Ratio
Standard Deviation 0.00627
|
1.0175 Ratio
Standard Deviation 0.00682
|
1.0217 Ratio
Standard Deviation 0.00687
|
1.0253 Ratio
Standard Deviation 0.00660
|
1.0169 Ratio
Standard Deviation 0.00946
|
1.0217 Ratio
Standard Deviation 0.00931
|
1.0175 Ratio
Standard Deviation 0.00544
|
1.0133 Ratio
Standard Deviation 0.00661
|
1.0167 Ratio
Standard Deviation 0.00736
|
1.0193 Ratio
Standard Deviation 0.00612
|
1.0152 Ratio
Standard Deviation 0.00817
|
|
Change From Baseline in Urine Specific Gravity
Change from baseline (up to approx. 4.5 years)
|
-0.0026 Ratio
Standard Deviation 0.00792
|
0.0067 Ratio
Standard Deviation 0.00830
|
0.0023 Ratio
Standard Deviation 0.00643
|
0.0003 Ratio
Standard Deviation 0.00058
|
-0.0090 Ratio
Standard Deviation 0.01217
|
-0.0013 Ratio
Standard Deviation 0.01072
|
0.0075 Ratio
Standard Deviation 0.00354
|
-0.0020 Ratio
Standard Deviation 0.00671
|
0.0050 Ratio
Standard Deviation 0.00707
|
0.0029 Ratio
Standard Deviation 0.01029
|
-0.0010 Ratio
Standard Deviation 0.00529
|
0.0005 Ratio
Standard Deviation 0.00782
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 4.5 yearsPopulation: All treated population. Data was not collected where number of participants analyzed is 0. Only those participants with data available at specified time points have been analyzed.
Blood pressures (DBP and SBP) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=17 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 91 DAY 1, 1hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
21.0 Millimeters of mercury (mmHg)
|
—
|
16.0 Millimeters of mercury (mmHg)
|
4.0 Millimeters of mercury (mmHg)
|
-15.0 Millimeters of mercury (mmHg)
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 153 DAY 8, 0.25hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
10.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 153 DAY 8, 1hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
4.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 169 DAY 1, Predose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
11.0 Millimeters of mercury (mmHg)
|
-16.5 Millimeters of mercury (mmHg)
Standard Deviation 26.16
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 133 DAY 1, 0.25hour Post-Dose
|
—
|
-2.0 Millimeters of mercury (mmHg)
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation 9.90
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-3.0 Millimeters of mercury (mmHg)
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, BASELINE (Day 1)
|
72.9 Millimeters of mercury (mmHg)
Standard Deviation 11.85
|
77.8 Millimeters of mercury (mmHg)
Standard Deviation 10.61
|
71.4 Millimeters of mercury (mmHg)
Standard Deviation 12.04
|
72.3 Millimeters of mercury (mmHg)
Standard Deviation 7.67
|
86.0 Millimeters of mercury (mmHg)
Standard Deviation 12.49
|
79.5 Millimeters of mercury (mmHg)
Standard Deviation 9.36
|
73.6 Millimeters of mercury (mmHg)
Standard Deviation 17.15
|
75.1 Millimeters of mercury (mmHg)
Standard Deviation 9.08
|
78.4 Millimeters of mercury (mmHg)
Standard Deviation 11.13
|
76.1 Millimeters of mercury (mmHg)
Standard Deviation 7.14
|
72.2 Millimeters of mercury (mmHg)
Standard Deviation 8.52
|
74.9 Millimeters of mercury (mmHg)
Standard Deviation 8.77
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 79 DAY 1, Predose
|
-1.0 Millimeters of mercury (mmHg)
|
-23.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
-5.0 Millimeters of mercury (mmHg)
|
3.0 Millimeters of mercury (mmHg)
|
—
|
—
|
19.0 Millimeters of mercury (mmHg)
|
2.0 Millimeters of mercury (mmHg)
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 79 DAY 1, 0.25hour Post-Dose
|
-11.0 Millimeters of mercury (mmHg)
|
-14.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
-8.0 Millimeters of mercury (mmHg)
|
-3.0 Millimeters of mercury (mmHg)
|
—
|
—
|
12.0 Millimeters of mercury (mmHg)
|
-2.0 Millimeters of mercury (mmHg)
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 79 DAY 1, 1hour Post-Dose
|
-10.0 Millimeters of mercury (mmHg)
|
-44.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
-5.0 Millimeters of mercury (mmHg)
|
-6.0 Millimeters of mercury (mmHg)
|
—
|
—
|
19.0 Millimeters of mercury (mmHg)
|
5.0 Millimeters of mercury (mmHg)
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 91 DAY 1, Predose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.0 Millimeters of mercury (mmHg)
|
—
|
4.0 Millimeters of mercury (mmHg)
|
-4.0 Millimeters of mercury (mmHg)
|
-26.0 Millimeters of mercury (mmHg)
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 91 DAY 1, 0.25hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation 0.0
|
—
|
10.0 Millimeters of mercury (mmHg)
|
1.0 Millimeters of mercury (mmHg)
|
-15.0 Millimeters of mercury (mmHg)
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 91 DAY 1, 1hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10.0 Millimeters of mercury (mmHg)
|
—
|
3.0 Millimeters of mercury (mmHg)
|
-2.0 Millimeters of mercury (mmHg)
|
-16.0 Millimeters of mercury (mmHg)
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 94 DAY 1, Predose
|
-2.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-24.0 Millimeters of mercury (mmHg)
|
—
|
4.0 Millimeters of mercury (mmHg)
|
-7.0 Millimeters of mercury (mmHg)
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 94 DAY 1, 0.25hour Post-Dose
|
3.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-21.0 Millimeters of mercury (mmHg)
|
—
|
6.0 Millimeters of mercury (mmHg)
|
4.0 Millimeters of mercury (mmHg)
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 94 DAY 1, 1hour Post-Dose
|
2.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-21.0 Millimeters of mercury (mmHg)
|
—
|
14.0 Millimeters of mercury (mmHg)
|
-5.0 Millimeters of mercury (mmHg)
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 109 DAY 1, Predose
|
—
|
-14.0 Millimeters of mercury (mmHg)
|
-1.7 Millimeters of mercury (mmHg)
Standard Deviation 2.08
|
5.0 Millimeters of mercury (mmHg)
|
—
|
2.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
-4.5 Millimeters of mercury (mmHg)
Standard Deviation 0.71
|
6.0 Millimeters of mercury (mmHg)
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 109 DAY 1, 0.25hour Post-Dose
|
—
|
-21.0 Millimeters of mercury (mmHg)
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation 6.24
|
-4.0 Millimeters of mercury (mmHg)
|
—
|
-2.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
1.5 Millimeters of mercury (mmHg)
Standard Deviation 7.78
|
6.0 Millimeters of mercury (mmHg)
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 109 DAY 1, 1hour Post-Dose
|
—
|
-27.0 Millimeters of mercury (mmHg)
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation 5.57
|
9.0 Millimeters of mercury (mmHg)
|
—
|
2.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
5.5 Millimeters of mercury (mmHg)
Standard Deviation 2.12
|
3.0 Millimeters of mercury (mmHg)
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 133 DAY 1, Predose
|
—
|
-16.0 Millimeters of mercury (mmHg)
|
-2.0 Millimeters of mercury (mmHg)
Standard Deviation 2.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.0 Millimeters of mercury (mmHg)
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 133 DAY 1, 0.25hour Post-Dose
|
—
|
-18.0 Millimeters of mercury (mmHg)
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation 7.07
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3.0 Millimeters of mercury (mmHg)
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 133 DAY 1, 1hour Post-Dose
|
—
|
-14.0 Millimeters of mercury (mmHg)
|
4.5 Millimeters of mercury (mmHg)
Standard Deviation 3.54
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8.0 Millimeters of mercury (mmHg)
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 153 DAY 8, Predose
|
—
|
—
|
—
|
—
|
—
|
5.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 169 DAY 1, 0.25hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.0 Millimeters of mercury (mmHg)
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation 4.24
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 169 DAY 1, 1hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7.0 Millimeters of mercury (mmHg)
|
-11.0 Millimeters of mercury (mmHg)
Standard Deviation 16.97
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 169 DAY 8, Predose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
11.0 Millimeters of mercury (mmHg)
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 169 DAY 8, 0.25hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.0 Millimeters of mercury (mmHg)
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 169 DAY 8, 1hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-5.0 Millimeters of mercury (mmHg)
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 173 DAY 1, Predose
|
—
|
—
|
—
|
—
|
-14.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 173 DAY 1, 0.25hour Post-Dose
|
—
|
—
|
—
|
—
|
-10.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 173 DAY 1, 1hour Post-Dose
|
—
|
—
|
—
|
—
|
-3.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 221 DAY 1, Predose
|
—
|
—
|
-2.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 221 DAY 1, 0.25hour Post-Dose
|
—
|
—
|
-10.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, WEEK 221 DAY 1, 1hour Post-Dose
|
—
|
—
|
2.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, BASELINE (Day 1)
|
126.8 Millimeters of mercury (mmHg)
Standard Deviation 21.48
|
138.5 Millimeters of mercury (mmHg)
Standard Deviation 21.29
|
125.3 Millimeters of mercury (mmHg)
Standard Deviation 15.71
|
127.8 Millimeters of mercury (mmHg)
Standard Deviation 18.62
|
137.5 Millimeters of mercury (mmHg)
Standard Deviation 7.05
|
136.1 Millimeters of mercury (mmHg)
Standard Deviation 26.03
|
136.4 Millimeters of mercury (mmHg)
Standard Deviation 18.99
|
129.7 Millimeters of mercury (mmHg)
Standard Deviation 15.13
|
132.8 Millimeters of mercury (mmHg)
Standard Deviation 17.88
|
135.4 Millimeters of mercury (mmHg)
Standard Deviation 16.68
|
122.3 Millimeters of mercury (mmHg)
Standard Deviation 13.94
|
143.3 Millimeters of mercury (mmHg)
Standard Deviation 25.93
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 79 DAY 1, Predose
|
-17.0 Millimeters of mercury (mmHg)
|
-21.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
11.0 Millimeters of mercury (mmHg)
|
5.0 Millimeters of mercury (mmHg)
|
—
|
—
|
8.0 Millimeters of mercury (mmHg)
|
16.0 Millimeters of mercury (mmHg)
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 79 DAY 1, 0.25hour Post-Dose
|
-36.0 Millimeters of mercury (mmHg)
|
-7.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
10.0 Millimeters of mercury (mmHg)
|
-3.0 Millimeters of mercury (mmHg)
|
—
|
—
|
8.0 Millimeters of mercury (mmHg)
|
9.0 Millimeters of mercury (mmHg)
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 79 DAY 1, 1hour Post-Dose
|
-41.0 Millimeters of mercury (mmHg)
|
-1.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
12.0 Millimeters of mercury (mmHg)
|
-2.0 Millimeters of mercury (mmHg)
|
—
|
—
|
-1.0 Millimeters of mercury (mmHg)
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation 0.0
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 91 DAY 1, Predose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-5.0 Millimeters of mercury (mmHg)
|
—
|
-2.0 Millimeters of mercury (mmHg)
|
4.0 Millimeters of mercury (mmHg)
|
-22.0 Millimeters of mercury (mmHg)
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 91 DAY 1, 0.25hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-15.0 Millimeters of mercury (mmHg)
|
—
|
17.0 Millimeters of mercury (mmHg)
|
12.0 Millimeters of mercury (mmHg)
|
-31.0 Millimeters of mercury (mmHg)
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 94 DAY 1, Predose
|
12.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-28.0 Millimeters of mercury (mmHg)
|
—
|
-5.0 Millimeters of mercury (mmHg)
|
-38.0 Millimeters of mercury (mmHg)
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 94 DAY 1, 0.25hour Post-Dose
|
3.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-30.0 Millimeters of mercury (mmHg)
|
—
|
-4.0 Millimeters of mercury (mmHg)
|
-23.0 Millimeters of mercury (mmHg)
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 94 DAY 1, 1hour Post-Dose
|
-5.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-35.0 Millimeters of mercury (mmHg)
|
—
|
-4.0 Millimeters of mercury (mmHg)
|
-32.0 Millimeters of mercury (mmHg)
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 109 DAY 1, Predose
|
—
|
-22.0 Millimeters of mercury (mmHg)
|
-4.7 Millimeters of mercury (mmHg)
Standard Deviation 16.01
|
9.0 Millimeters of mercury (mmHg)
|
—
|
-1.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
-1.0 Millimeters of mercury (mmHg)
Standard Deviation 5.66
|
-11.0 Millimeters of mercury (mmHg)
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 109 DAY 1, 0.25hour Post-Dose
|
—
|
-23.0 Millimeters of mercury (mmHg)
|
1.3 Millimeters of mercury (mmHg)
Standard Deviation 15.89
|
3.0 Millimeters of mercury (mmHg)
|
—
|
1.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
-7.5 Millimeters of mercury (mmHg)
Standard Deviation 0.71
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation 0.0
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 109 DAY 1, 1hour Post-Dose
|
—
|
-31.0 Millimeters of mercury (mmHg)
|
7.3 Millimeters of mercury (mmHg)
Standard Deviation 16.56
|
3.0 Millimeters of mercury (mmHg)
|
—
|
-3.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
-1.5 Millimeters of mercury (mmHg)
Standard Deviation 4.95
|
8.0 Millimeters of mercury (mmHg)
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 133 DAY 1, Predose
|
—
|
-16.0 Millimeters of mercury (mmHg)
|
-9.0 Millimeters of mercury (mmHg)
Standard Deviation 1.41
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.0 Millimeters of mercury (mmHg)
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 133 DAY 1, 1hour Post-Dose
|
—
|
-1.0 Millimeters of mercury (mmHg)
|
5.0 Millimeters of mercury (mmHg)
Standard Deviation 19.80
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-1.0 Millimeters of mercury (mmHg)
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 153 DAY 8, Predose
|
—
|
—
|
—
|
—
|
—
|
-3.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 153 DAY 8, 0.25hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
13.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 153 DAY 8, 1hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
7.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 169 DAY 1, Predose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-5.0 Millimeters of mercury (mmHg)
|
-16.5 Millimeters of mercury (mmHg)
Standard Deviation 28.99
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 169 DAY 1, 0.25hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-5.0 Millimeters of mercury (mmHg)
|
-9.5 Millimeters of mercury (mmHg)
Standard Deviation 7.78
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 169 DAY 1, 1hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-1.0 Millimeters of mercury (mmHg)
|
-6.5 Millimeters of mercury (mmHg)
Standard Deviation 9.19
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 169 DAY 8, Predose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10.0 Millimeters of mercury (mmHg)
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 169 DAY 8, 0.25hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
11.0 Millimeters of mercury (mmHg)
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 169 DAY 8, 1hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
17.0 Millimeters of mercury (mmHg)
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 173 DAY 1, Predose
|
—
|
—
|
—
|
—
|
-7.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 173 DAY 1, 0.25hour Post-Dose
|
—
|
—
|
—
|
—
|
-7.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 173 DAY 1, 1hour Post-Dose
|
—
|
—
|
—
|
—
|
-5.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 221 DAY 1, Predose
|
—
|
—
|
18.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 221 DAY 1, 0.25hour Post-Dose
|
—
|
—
|
15.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, WEEK 221 DAY 1, 1hour Post-Dose
|
—
|
—
|
32.0 Millimeters of mercury (mmHg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 4.5 yearsPopulation: All treated population. Only those participants with data available at specified time points have been analyzed.
Pulse rate was measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=17 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Vital Signs : Pulse Rate
BASELINE (Day 1)
|
81.0 beats per minute
Standard Deviation 10.05
|
75.3 beats per minute
Standard Deviation 10.82
|
72.8 beats per minute
Standard Deviation 14.65
|
72.8 beats per minute
Standard Deviation 9.01
|
73.8 beats per minute
Standard Deviation 11.90
|
76.0 beats per minute
Standard Deviation 17.10
|
73.7 beats per minute
Standard Deviation 13.05
|
76.2 beats per minute
Standard Deviation 12.69
|
75.5 beats per minute
Standard Deviation 11.21
|
79.6 beats per minute
Standard Deviation 13.36
|
73.3 beats per minute
Standard Deviation 14.31
|
74.1 beats per minute
Standard Deviation 10.76
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 79 DAY 1, Predose
|
1.0 beats per minute
|
4.0 beats per minute
|
—
|
—
|
—
|
—
|
-9.0 beats per minute
|
-18.0 beats per minute
|
—
|
—
|
-14.0 beats per minute
|
9.0 beats per minute
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 79 DAY 1, 0.25hour Post-Dose
|
2.0 beats per minute
|
-9.0 beats per minute
|
—
|
—
|
—
|
—
|
-6.0 beats per minute
|
-6.0 beats per minute
|
—
|
—
|
6.0 beats per minute
|
-2.0 beats per minute
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 79 DAY 1, 1hour Post-Dose
|
4.0 beats per minute
|
-6.0 beats per minute
|
—
|
—
|
—
|
—
|
-18.0 beats per minute
|
6.0 beats per minute
|
—
|
—
|
13.0 beats per minute
|
-2.0 beats per minute
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 91 DAY 1, Predose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.0 beats per minute
|
—
|
-5.0 beats per minute
|
24.0 beats per minute
|
-5.0 beats per minute
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 91 DAY 1, 0.25hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-2.0 beats per minute
|
—
|
-19.0 beats per minute
|
12.0 beats per minute
|
-9.0 beats per minute
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 91 DAY 1, 1hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-6.0 beats per minute
|
—
|
-11.0 beats per minute
|
11.0 beats per minute
|
-19.0 beats per minute
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 94 DAY 1, Predose
|
13.0 beats per minute
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-5.0 beats per minute
|
—
|
-14.0 beats per minute
|
21.0 beats per minute
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 94 DAY 1, 0.25hour Post-Dose
|
12.0 beats per minute
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-4.0 beats per minute
|
—
|
-22.0 beats per minute
|
16.0 beats per minute
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 94 DAY 1, 1hour Post-Dose
|
14.0 beats per minute
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-4.0 beats per minute
|
—
|
-28.0 beats per minute
|
11.0 beats per minute
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 109 DAY 1, Predose
|
—
|
-9.0 beats per minute
|
8.3 beats per minute
Standard Deviation 5.13
|
-19.0 beats per minute
|
—
|
-22.0 beats per minute
|
—
|
—
|
—
|
—
|
-6.0 beats per minute
Standard Deviation 8.49
|
-12.0 beats per minute
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 109 DAY 1, 0.25hour Post-Dose
|
—
|
-8.0 beats per minute
|
0.3 beats per minute
Standard Deviation 3.06
|
-18.0 beats per minute
|
—
|
-24.0 beats per minute
|
—
|
—
|
—
|
—
|
10.5 beats per minute
Standard Deviation 41.72
|
-16.0 beats per minute
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 109 DAY 1, 1hour Post-Dose
|
—
|
0.0 beats per minute
|
1.3 beats per minute
Standard Deviation 5.69
|
-4.0 beats per minute
|
—
|
-25.0 beats per minute
|
—
|
—
|
—
|
—
|
-8.0 beats per minute
Standard Deviation 11.31
|
-12.0 beats per minute
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 133 DAY 1, Predose
|
—
|
-5.0 beats per minute
|
6.5 beats per minute
Standard Deviation 9.19
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-11.0 beats per minute
|
—
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 133 DAY 1, 0.25hour Post-Dose
|
—
|
-5.0 beats per minute
|
4.5 beats per minute
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-12.0 beats per minute
|
—
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 133 DAY 1, 1hour Post-Dose
|
—
|
-17.0 beats per minute
|
5.5 beats per minute
Standard Deviation 2.12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-16.0 beats per minute
|
—
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 153 DAY 8, Predose
|
—
|
—
|
—
|
—
|
—
|
-8.0 beats per minute
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 153 DAY 8, 0.25hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
-10.0 beats per minute
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 153 DAY 8, 1hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
-9.0 beats per minute
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 169 DAY 1, Predose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-15.0 beats per minute
|
-21.0 beats per minute
Standard Deviation 5.66
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 169 DAY 1, 0.25hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-23.0 beats per minute
|
-19.0 beats per minute
Standard Deviation 2.83
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 169 DAY 1, 1hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-20.0 beats per minute
|
-21.0 beats per minute
Standard Deviation 1.41
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 169 DAY 8, Predose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-21.0 beats per minute
|
—
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 169 DAY 8, 0.25hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-17.0 beats per minute
|
—
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 169 DAY 8, 1hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-20.0 beats per minute
|
—
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 173 DAY 1, Predose
|
—
|
—
|
—
|
—
|
-7.0 beats per minute
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 173 DAY 1, 0.25hour Post-Dose
|
—
|
—
|
—
|
—
|
-5.0 beats per minute
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 173 DAY 1, 1hour Post-Dose
|
—
|
—
|
—
|
—
|
-8.0 beats per minute
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 221 DAY 1, Predose
|
—
|
—
|
-4.0 beats per minute
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 221 DAY 1, 0.25hour Post-Dose
|
—
|
—
|
2.0 beats per minute
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs : Pulse Rate
WEEK 221 DAY 1, 1hour Post-Dose
|
—
|
—
|
8.0 beats per minute
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 4.5 yearsPopulation: All treated population. Only those participants with data available at specified time points have been analyzed.
Temperature was measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=17 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Vital Signs : Temperature
WEEK 94 DAY 1, 1hour Post-Dose
|
0.30 Degree Celsius (C)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-0.40 Degree Celsius (C)
|
—
|
0.00 Degree Celsius (C)
Standard Deviation 0.00
|
0.10 Degree Celsius (C)
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 153 DAY 8, Predose
|
—
|
—
|
—
|
—
|
—
|
0.20 Degree Celsius (C)
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 169 DAY 8, 1hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-0.30 Degree Celsius (C)
|
—
|
|
Change From Baseline in Vital Signs : Temperature
BASELINE (Day 1)
|
36.51 Degree Celsius (C)
Standard Deviation 0.581
|
36.58 Degree Celsius (C)
Standard Deviation 0.397
|
36.43 Degree Celsius (C)
Standard Deviation 0.334
|
36.61 Degree Celsius (C)
Standard Deviation 0.417
|
36.70 Degree Celsius (C)
Standard Deviation 0.346
|
36.46 Degree Celsius (C)
Standard Deviation 0.307
|
36.46 Degree Celsius (C)
Standard Deviation 0.348
|
36.44 Degree Celsius (C)
Standard Deviation 0.291
|
36.52 Degree Celsius (C)
Standard Deviation 0.432
|
36.68 Degree Celsius (C)
Standard Deviation 0.305
|
36.53 Degree Celsius (C)
Standard Deviation 0.338
|
36.48 Degree Celsius (C)
Standard Deviation 0.571
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 79 DAY 1, Predose
|
1.30 Degree Celsius (C)
|
0.00 Degree Celsius (C)
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
-0.30 Degree Celsius (C)
|
0.10 Degree Celsius (C)
|
—
|
—
|
0.70 Degree Celsius (C)
|
-0.10 Degree Celsius (C)
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 79 DAY 1, 0.25hour Post-Dose
|
1.60 Degree Celsius (C)
|
0.00 Degree Celsius (C)
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
-0.30 Degree Celsius (C)
|
0.10 Degree Celsius (C)
|
—
|
—
|
-0.20 Degree Celsius (C)
|
-0.10 Degree Celsius (C)
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 79 DAY 1, 1hour Post-Dose
|
1.40 Degree Celsius (C)
|
0.00 Degree Celsius (C)
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
-0.10 Degree Celsius (C)
|
0.40 Degree Celsius (C)
|
—
|
—
|
0.50 Degree Celsius (C)
|
0.00 Degree Celsius (C)
Standard Deviation 0.00
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 91 DAY 1, Predose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.40 Degree Celsius (C)
|
—
|
-0.60 Degree Celsius (C)
|
0.50 Degree Celsius (C)
|
-0.70 Degree Celsius (C)
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 91 DAY 1, 0.25hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.40 Degree Celsius (C)
|
—
|
-0.80 Degree Celsius (C)
|
0.10 Degree Celsius (C)
|
0.20 Degree Celsius (C)
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 91 DAY 1, 1hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.50 Degree Celsius (C)
|
—
|
-0.50 Degree Celsius (C)
|
0.50 Degree Celsius (C)
|
0.30 Degree Celsius (C)
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 94 DAY 1, Predose
|
0.30 Degree Celsius (C)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-0.20 Degree Celsius (C)
|
—
|
0.10 Degree Celsius (C)
|
-0.30 Degree Celsius (C)
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 94 DAY 1, 0.25hour Post-Dose
|
0.30 Degree Celsius (C)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-0.30 Degree Celsius (C)
|
—
|
0.30 Degree Celsius (C)
|
0.10 Degree Celsius (C)
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 109 DAY 1, Predose
|
—
|
0.40 Degree Celsius (C)
|
0.20 Degree Celsius (C)
Standard Deviation 0.173
|
-0.90 Degree Celsius (C)
|
—
|
-0.80 Degree Celsius (C)
|
—
|
—
|
—
|
—
|
0.20 Degree Celsius (C)
Standard Deviation 0.283
|
-0.20 Degree Celsius (C)
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 109 DAY 1, 0.25hour Post-Dose
|
—
|
0.40 Degree Celsius (C)
|
0.07 Degree Celsius (C)
Standard Deviation 0.153
|
-1.20 Degree Celsius (C)
|
—
|
-0.80 Degree Celsius (C)
|
—
|
—
|
—
|
—
|
0.15 Degree Celsius (C)
Standard Deviation 0.071
|
0.20 Degree Celsius (C)
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 109 DAY 1, 1hour Post-Dose
|
—
|
0.40 Degree Celsius (C)
|
0.10 Degree Celsius (C)
Standard Deviation 0.173
|
-1.20 Degree Celsius (C)
|
—
|
-0.50 Degree Celsius (C)
|
—
|
—
|
—
|
—
|
0.15 Degree Celsius (C)
Standard Deviation 0.071
|
0.10 Degree Celsius (C)
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 133 DAY 1, Predose
|
—
|
1.00 Degree Celsius (C)
|
0.60 Degree Celsius (C)
Standard Deviation 0.283
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.40 Degree Celsius (C)
|
—
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 133 DAY 1, 0.25hour Post-Dose
|
—
|
0.70 Degree Celsius (C)
|
0.25 Degree Celsius (C)
Standard Deviation 0.071
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.30 Degree Celsius (C)
|
—
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 133 DAY 1, 1hour Post-Dose
|
—
|
0.20 Degree Celsius (C)
|
0.45 Degree Celsius (C)
Standard Deviation 0.071
|
—
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—
|
—
|
—
|
—
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—
|
—
|
0.10 Degree Celsius (C)
|
—
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 148 DAY 8, Predose
|
0.00 Degree Celsius (C)
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 148 DAY 8, 0.25hour Post-Dose
|
-0.30 Degree Celsius (C)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 148 DAY 8, 1hour Post-Dose
|
-0.30 Degree Celsius (C)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 153 DAY 8, 0.25hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
-0.10 Degree Celsius (C)
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 153 DAY 8, 1hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
0.00 Degree Celsius (C)
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 169 DAY 1, Predose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-0.20 Degree Celsius (C)
|
0.10 Degree Celsius (C)
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 169 DAY 1, 0.25hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.10 Degree Celsius (C)
|
0.05 Degree Celsius (C)
Standard Deviation 0.636
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 169 DAY 1, 1hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.10 Degree Celsius (C)
|
-0.05 Degree Celsius (C)
Standard Deviation 0.071
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 169 DAY 8, Predose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-0.20 Degree Celsius (C)
|
—
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 169 DAY 8, 0.25hour Post-Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.40 Degree Celsius (C)
|
—
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 173 DAY 1, Predose
|
—
|
—
|
—
|
—
|
-0.30 Degree Celsius (C)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 173 DAY 1, 0.25hour Post-Dose
|
—
|
—
|
—
|
—
|
-0.40 Degree Celsius (C)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 173 DAY 1, 1hour Post-Dose
|
—
|
—
|
—
|
—
|
-0.40 Degree Celsius (C)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 221 DAY 1, Predose
|
—
|
—
|
-0.10 Degree Celsius (C)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 221 DAY 1, 0.25hour Post-Dose
|
—
|
—
|
-0.10 Degree Celsius (C)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Vital Signs : Temperature
WEEK 221 DAY 1, 1hour Post-Dose
|
—
|
—
|
-0.20 Degree Celsius (C)
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
|
PRIMARY outcome
Timeframe: Up to approximately 4.5 yearsPopulation: All treated population.
ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response \[VGPR\], complete response \[CR\] and stringent complete response \[sCR\]), according to the International Myeloma Working Group (IMWG) Response Criteria. CR: negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasmacytomas in the bone marrow; sCR: stringent complete response, CR as above plus normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-component detectable by immunofixation but not on electrophoresis OR \>= 90% reduction in serum M-component plus urine M-component \<100 mg/24 h; PR: \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg/24 h. Confidence intervals were based on the exact method.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) as Defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma (MM)
|
50 Percentage of Participants
Interval 21.1 to 78.9
|
69 Percentage of Participants
Interval 41.3 to 89.0
|
69 Percentage of Participants
Interval 41.3 to 89.0
|
58 Percentage of Participants
Interval 27.7 to 84.8
|
75 Percentage of Participants
Interval 19.4 to 99.4
|
69 Percentage of Participants
Interval 38.6 to 90.9
|
50 Percentage of Participants
Interval 21.1 to 78.9
|
83 Percentage of Participants
Interval 51.6 to 97.9
|
92 Percentage of Participants
Interval 61.5 to 99.8
|
75 Percentage of Participants
Interval 42.8 to 94.5
|
62 Percentage of Participants
Interval 31.6 to 86.1
|
78 Percentage of Participants
Interval 52.4 to 93.6
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 8Population: Pharmacokinetic (PK) population included all participants in all treated population from whom at least one PK sample was obtained, analyzed, and was measurable. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated timepoints for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=15 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC), Treatment A
CYCLE 1 DAY 1
|
—
|
—
|
39.99 Microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 25.03
|
43.58 Microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 21.78
|
36.41 Microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 17.06
|
25.22 Microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 16.53
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC), Treatment A
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
27.60 Microgram/ millilitre (ug/mL)
Geometric Coefficient of Variation 16.27
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=3 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve (AUC) From Time 0 to 504 Hours (0-504h) for Belantamab Mafodotin ADC, Treatment A
|
—
|
—
|
4127.66 Hour*microgram/millilitre (h*ug/mL)
Geometric Coefficient of Variation 17.98
|
3848.41 Hour*microgram/millilitre (h*ug/mL)
Geometric Coefficient of Variation 24.25
|
4802.83 Hour*microgram/millilitre (h*ug/mL)
Geometric Coefficient of Variation 34.51
|
4365.82 Hour*microgram/millilitre (h*ug/mL)
Geometric Coefficient of Variation 10.25
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 28Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=3 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-672h) for Belantamab Mafodotin ADC, Treatment A
|
—
|
—
|
4432.11 h*ug/mL
Geometric Coefficient of Variation 17.65
|
4093.12 h*ug/mL
Geometric Coefficient of Variation 24.45
|
5114.28 h*ug/mL
Geometric Coefficient of Variation 34.72
|
4699.00 h*ug/mL
Geometric Coefficient of Variation 11.10
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=15 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Concentration (Tmax) for Belantamab Mafodotin ADC, Treatment A
CYCLE 1 DAY 1
|
—
|
—
|
2.000 Hour
Interval 0.53 to 2.42
|
2.050 Hour
Interval 0.57 to 2.37
|
1.342 Hour
Interval 0.5 to 2.17
|
1.100 Hour
Interval 0.57 to 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum Observed Concentration (Tmax) for Belantamab Mafodotin ADC, Treatment A
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
1.108 Hour
Interval 0.57 to 23.93
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 29; pre-dose Cycle 2 Day 28Population: Pharmacokinetic (PK) population.
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time of Last Observed Quantifiable Concentration (Tlast) for Belantamab Mafodotin ADC, Treatment A
|
—
|
—
|
671.717 Hour
Interval 2.0 to 1342.83
|
181.467 Hour
Interval 25.5 to 698.22
|
685.608 Hour
Interval 191.58 to 697.75
|
674.833 Hour
Interval 94.4 to 1273.75
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Days 1 and 8; Weeks 5, 9, and 13: Pre-Dose and Post-Dose on Days 1 and 8Population: Pharmacokinetic (PK) population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=1 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=3 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Belantamab Mafodotin ADC, Treatment A
CYCLE 1 DAY 1
|
—
|
—
|
1.08 ug/mL
Interval 0.7 to 1.5
|
—
|
1.79 ug/mL
Interval 0.7 to 1.8
|
3.52 ug/mL
Interval 2.5 to 4.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Belantamab Mafodotin ADC, Treatment A
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
1.30 ug/mL
Interval 0.7 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Belantamab Mafodotin ADC, Treatment A
WEEK 5 DAY 1
|
—
|
—
|
NA ug/mL
Interval 0.6 to 1.0
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
NA ug/mL
Interval 0.5 to 2.6
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
5.05 ug/mL
Interval 2.4 to 7.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Belantamab Mafodotin ADC, Treatment A
WEEK 5 DAY 8
|
—
|
—
|
—
|
—
|
—
|
1.17 ug/mL
Interval 0.1 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Belantamab Mafodotin ADC, Treatment A
WEEK 9 DAY 1
|
—
|
—
|
NA ug/mL
Interval 2.3 to 2.9
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
NA ug/mL
Interval 2.3 to 2.3
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
4.89 ug/mL
Interval 3.0 to 8.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Belantamab Mafodotin ADC, Treatment A
WEEK 9 DAY 8
|
—
|
—
|
—
|
—
|
—
|
2.03 ug/mL
Interval 1.8 to 3.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Belantamab Mafodotin ADC, Treatment A
WEEK 13 DAY 1
|
—
|
—
|
NA ug/mL
Interval 2.3 to 3.5
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 0.7 to 0.7
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
NA ug/mL
Interval 4.4 to 6.5
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Belantamab Mafodotin ADC, Treatment A
WEEK 13 DAY 8
|
—
|
—
|
—
|
—
|
—
|
NA ug/mL
Interval 1.6 to 1.6
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Days 1 and Day 8; Weeks 5, 9, and 13: Pre-Dose and Post-Dose on Days 1 and 8Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=15 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=11 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Observed Plasma Concentration at the End of Infusion (C-EOI) for Belantamab Mafodotin ADC, Treatment A
CYCLE 1 DAY 1
|
—
|
—
|
41.80 ug/mL
Interval 14.0 to 51.3
|
39.10 ug/mL
Interval 27.2 to 49.5
|
36.05 ug/mL
Interval 29.6 to 44.5
|
25.05 ug/mL
Interval 18.2 to 31.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Observed Plasma Concentration at the End of Infusion (C-EOI) for Belantamab Mafodotin ADC, Treatment A
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
26.55 ug/mL
Interval 18.6 to 35.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Observed Plasma Concentration at the End of Infusion (C-EOI) for Belantamab Mafodotin ADC, Treatment A
WEEK 5 DAY 1
|
—
|
—
|
36.75 ug/mL
Interval 25.6 to 96.2
|
—
|
35.45 ug/mL
Interval 33.8 to 42.0
|
23.00 ug/mL
Interval 20.5 to 27.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Observed Plasma Concentration at the End of Infusion (C-EOI) for Belantamab Mafodotin ADC, Treatment A
WEEK 5 DAY 8
|
—
|
—
|
—
|
—
|
—
|
27.10 ug/mL
Interval 23.6 to 41.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Observed Plasma Concentration at the End of Infusion (C-EOI) for Belantamab Mafodotin ADC, Treatment A
WEEK 9 DAY 1
|
—
|
—
|
NA ug/mL
Interval 30.4 to 55.5
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
42.35 ug/mL
Interval 31.1 to 49.5
|
NA ug/mL
Interval 34.5 to 34.5
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
23.50 ug/mL
Interval 15.3 to 31.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Observed Plasma Concentration at the End of Infusion (C-EOI) for Belantamab Mafodotin ADC, Treatment A
WEEK 9 DAY 8
|
—
|
—
|
—
|
—
|
—
|
25.60 ug/mL
Interval 17.1 to 31.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Observed Plasma Concentration at the End of Infusion (C-EOI) for Belantamab Mafodotin ADC, Treatment A
WEEK 13 DAY 1
|
—
|
—
|
38.40 ug/mL
Interval 28.1 to 50.9
|
NA ug/mL
Interval 27.1 to 27.1
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
NA ug/mL
Interval 16.8 to 31.6
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Observed Plasma Concentration at the End of Infusion (C-EOI) for Belantamab Mafodotin ADC, Treatment A
WEEK 13 DAY 8
|
—
|
—
|
—
|
—
|
—
|
NA ug/mL
Interval 21.7 to 30.2
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax for Belantamab Mafodotin ADC, Treatment B
CYCLE 1 DAY 1
|
—
|
—
|
51.29 ug/mL
Geometric Coefficient of Variation 26.03
|
52.24 ug/mL
Geometric Coefficient of Variation 31.87
|
49.50 ug/mL
Geometric Coefficient of Variation 21.38
|
61.16 ug/mL
Geometric Coefficient of Variation 36.74
|
21.34 ug/mL
Geometric Coefficient of Variation 34.67
|
46.95 ug/mL
Geometric Coefficient of Variation 23.24
|
27.79 ug/mL
Geometric Coefficient of Variation 37.28
|
64.00 ug/mL
Geometric Coefficient of Variation 38.60
|
—
|
—
|
|
Cmax for Belantamab Mafodotin ADC, Treatment B
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
24.46 ug/mL
Geometric Coefficient of Variation 32.10
|
—
|
31.96 ug/mL
Geometric Coefficient of Variation 32.79
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 21Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=7 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=7 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=10 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=7 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=15 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=8 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-504h) for Belantamab Mafodotin ADC, Treatment B
|
—
|
—
|
5395.98 h*ug/mL
Geometric Coefficient of Variation 20.49
|
6129.71 h*ug/mL
Geometric Coefficient of Variation 23.83
|
4451.74 h*ug/mL
Geometric Coefficient of Variation 23.33
|
6073.99 h*ug/mL
Geometric Coefficient of Variation 37.06
|
4341.73 h*ug/mL
Geometric Coefficient of Variation 22.36
|
5013.84 h*ug/mL
Geometric Coefficient of Variation 31.91
|
5702.03 h*ug/mL
Geometric Coefficient of Variation 26.30
|
6230.16 h*ug/mL
Geometric Coefficient of Variation 35.02
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 11; Cycle 1 Day 22; Pre-Dose and Post-Dose on Week 5 Day 7Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed. As per protocol, blood sampling for PK was performed for only specified treatment arms for this OM and hence there are 0 participants analyzed for rest of the arms.
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC(0-1008h) was derived only for Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex, Belantamab mafodotin 2.5 mg/kg StepDown STRETCH + Bor/Dex and Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex cohorts.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=6 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=5 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=10 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-1008h) for Belantamab Mafodotin ADC, Treatment B
|
—
|
—
|
6487.41 h*ug/mL
Geometric Coefficient of Variation 26.24
|
7084.63 h*ug/mL
Geometric Coefficient of Variation 24.82
|
—
|
7396.49 h*ug/mL
Geometric Coefficient of Variation 25.94
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax for Belantamab Mafodotin ADC, Treatment B
CYCLE 1 DAY 1
|
—
|
—
|
1.175 Hour
Interval 0.62 to 2.57
|
1.900 Hour
Interval 0.63 to 22.5
|
1.125 Hour
Interval 0.55 to 2.62
|
2.025 Hour
Interval 0.63 to 25.95
|
1.233 Hour
Interval 0.5 to 2.22
|
1.308 Hour
Interval 0.45 to 2.7
|
0.583 Hour
Interval 0.5 to 2.2
|
2.000 Hour
Interval 0.52 to 3.83
|
—
|
—
|
|
Tmax for Belantamab Mafodotin ADC, Treatment B
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
0.733 Hour
Interval 0.52 to 336.75
|
—
|
0.642 Hour
Interval 0.4 to 2.05
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 5 Day 1Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tlast for Belantamab Mafodotin ADC, Treatment B
|
—
|
—
|
755.442 Hour
Interval 22.68 to 2018.57
|
540.250 Hour
Interval 75.67 to 1052.33
|
505.592 Hour
Interval 503.75 to 1220.95
|
1009.933 Hour
Interval 500.93 to 1489.0
|
504.567 Hour
Interval 144.83 to 1351.17
|
506.817 Hour
Interval 167.5 to 577.33
|
503.458 Hour
Interval 239.72 to 1584.5
|
506.092 Hour
Interval 2.0 to 2022.58
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=5 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=15 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=14 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ctrough for Belantamab Mafodotin ADC, Treatment B
WEEK 7 DAY 1
|
—
|
—
|
NA ug/mL
Interval 0.7 to 1.9
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 1.7 to 1.7
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
3.90 ug/mL
Interval 0.5 to 6.4
|
1.24 ug/mL
Interval 0.6 to 2.8
|
5.85 ug/mL
Interval 4.0 to 8.1
|
2.72 ug/mL
Interval 0.1 to 3.7
|
10.10 ug/mL
Interval 5.7 to 13.9
|
—
|
—
|
—
|
|
Ctrough for Belantamab Mafodotin ADC, Treatment B
WEEK 10 DAY 1
|
—
|
—
|
—
|
—
|
—
|
NA ug/mL
Interval 0.6 to 0.7
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 6.6 to 6.6
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
NA ug/mL
Interval 4.9 to 4.9
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 4.9 to 4.9
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
|
Ctrough for Belantamab Mafodotin ADC, Treatment B
WEEK 13 DAY 1
|
—
|
—
|
NA ug/mL
Interval 2.0 to 3.4
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 3.2 to 3.2
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
1.40 ug/mL
Interval 0.7 to 2.1
|
—
|
NA ug/mL
Interval 6.3 to 6.3
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 10.3 to 10.3
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 1.5 to 5.7
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
|
Ctrough for Belantamab Mafodotin ADC, Treatment B
WEEK 13 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA ug/mL
Interval 1.7 to 1.7
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
|
Ctrough for Belantamab Mafodotin ADC, Treatment B
CYCLE 1 DAY 1
|
—
|
—
|
0.84 ug/mL
Interval 0.5 to 1.0
|
1.12 ug/mL
Interval 0.5 to 1.5
|
1.92 ug/mL
Interval 0.6 to 3.9
|
0.63 ug/mL
Interval 0.5 to 1.2
|
3.50 ug/mL
Interval 1.8 to 7.1
|
2.12 ug/mL
Interval 1.1 to 5.4
|
4.25 ug/mL
Interval 1.6 to 11.7
|
2.10 ug/mL
Interval 0.5 to 4.3
|
—
|
—
|
|
Ctrough for Belantamab Mafodotin ADC, Treatment B
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
3.72 ug/mL
Interval 0.7 to 24.3
|
—
|
3.93 ug/mL
Interval 1.7 to 9.0
|
—
|
—
|
—
|
|
Ctrough for Belantamab Mafodotin ADC, Treatment B
WEEK 4 DAY 1
|
—
|
—
|
—
|
—
|
3.23 ug/mL
Interval 1.4 to 5.4
|
—
|
4.39 ug/mL
Interval 3.0 to 8.6
|
1.32 ug/mL
Interval 0.6 to 8.6
|
3.62 ug/mL
Interval 1.4 to 6.2
|
2.53 ug/mL
Interval 0.6 to 4.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 7 Day 11, Week 10 Day 1, Week 10 Day 8, Week 13 Day 1, Week 13 Day 8Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
C-EOI for Belantamab Mafodotin ADC, Treatment B
CYCLE 1 DAY 1
|
—
|
—
|
45.25 ug/mL
Interval 31.4 to 76.7
|
44.75 ug/mL
Interval 26.8 to 68.0
|
44.05 ug/mL
Interval 36.1 to 61.5
|
52.00 ug/mL
Interval 22.8 to 88.8
|
22.30 ug/mL
Interval 12.9 to 30.6
|
45.80 ug/mL
Interval 29.1 to 57.6
|
30.10 ug/mL
Interval 11.0 to 49.1
|
54.85 ug/mL
Interval 37.2 to 215.0
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin ADC, Treatment B
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
22.60 ug/mL
Interval 12.2 to 48.4
|
—
|
32.60 ug/mL
Interval 17.5 to 55.7
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin ADC, Treatment B
WEEK 4 DAY 1
|
—
|
—
|
—
|
—
|
46.00 ug/mL
Interval 30.5 to 64.0
|
—
|
27.10 ug/mL
Interval 16.7 to 32.4
|
44.50 ug/mL
Interval 26.8 to 254.0
|
26.20 ug/mL
Interval 14.6 to 53.2
|
51.20 ug/mL
Interval 45.7 to 57.8
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin ADC, Treatment B
WEEK 7 DAY 1
|
—
|
—
|
42.50 ug/mL
Interval 25.9 to 84.1
|
48.60 ug/mL
Interval 37.9 to 83.6
|
44.30 ug/mL
Interval 3.4 to 71.8
|
36.45 ug/mL
Interval 26.5 to 76.9
|
26.30 ug/mL
Interval 19.1 to 29.7
|
31.70 ug/mL
Interval 18.2 to 62.7
|
27.40 ug/mL
Interval 12.1 to 38.6
|
38.35 ug/mL
Interval 37.0 to 55.8
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin ADC, Treatment B
WEEK 7 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
NA ug/mL
Interval 21.0 to 32.6
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
NA ug/mL
Interval 37.0 to 45.1
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin ADC, Treatment B
WEEK 7 DAY 11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA ug/mL
Interval 19.1 to 19.1
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin ADC, Treatment B
WEEK 10 DAY 1
|
—
|
—
|
NA ug/mL
Interval 81.8 to 81.8
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
38.00 ug/mL
Interval 31.9 to 43.3
|
NA ug/mL
Interval 24.9 to 33.2
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
NA ug/mL
Interval 28.7 to 28.7
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 60.3 to 60.3
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin ADC, Treatment B
WEEK 10 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
NA ug/mL
Interval 28.2 to 28.2
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin ADC, Treatment B
WEEK 13 DAY 1
|
—
|
—
|
NA ug/mL
Interval 70.8 to 95.7
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 33.3 to 33.3
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 46.9 to 46.9
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
43.30 ug/mL
Interval 31.1 to 60.1
|
—
|
NA ug/mL
Interval 33.5 to 43.5
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 27.9 to 27.9
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
46.60 ug/mL
Interval 41.4 to 62.3
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin ADC, Treatment B
WEEK 13 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA ug/mL
Interval 37.0 to 37.0
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax for Belantamab Mafodotin (Total Antibody), Treatment A
CYCLE 1 DAY 1
|
—
|
—
|
46.95 ug/mL
Geometric Coefficient of Variation 30.63
|
43.09 ug/mL
Geometric Coefficient of Variation 22.26
|
40.18 ug/mL
Geometric Coefficient of Variation 13.23
|
26.64 ug/mL
Geometric Coefficient of Variation 14.97
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax for Belantamab Mafodotin (Total Antibody), Treatment A
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
35.11 ug/mL
Geometric Coefficient of Variation 13.68
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=10 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-504h) for Belantamab Mafodotin (Total Antibody), Treatment A
|
—
|
—
|
7277.25 h*ug/mL
Geometric Coefficient of Variation 28.00
|
6648.19 h*ug/mL
Geometric Coefficient of Variation 35.67
|
6607.45 h*ug/mL
Geometric Coefficient of Variation 35.62
|
6909.91 h*ug/mL
Geometric Coefficient of Variation 24.70
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 28Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=10 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-672h) for Belantamab Mafodotin (Total Antibody), Treatment A
|
—
|
—
|
8146.00 h*ug/mL
Geometric Coefficient of Variation 28.29
|
7408.65 h*ug/mL
Geometric Coefficient of Variation 36.03
|
7249.58 h*ug/mL
Geometric Coefficient of Variation 39.00
|
7828.12 h*ug/mL
Geometric Coefficient of Variation 27.15
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 29; Pre-Dose and Post-Dose on Week 5 Day 7Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC(0-1008) was derived only for Belantamab mafodotin 1.9mg/kg + Len/Dex STRETCH cohort.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=5 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-1008h) for Belantamab Mafodotin (Total Antibody), Treatment A
|
—
|
—
|
—
|
8143.85 h*ug/mL
Geometric Coefficient of Variation 30.12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 29; Pre-Dose and Post-Dose on Week 7 Day 7Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC(0-1344) was derived only for Belantamab mafodotin 1.9mg/kg + Len/Dex STRETCH cohort.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=5 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-1344h) for Belantamab Mafodotin (Total Antibody), Treatment A
|
—
|
—
|
—
|
8633.05 h*ug/mL
Geometric Coefficient of Variation 30.26
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax for Belantamab Mafodotin (Total Antibody), Treatment A
CYCLE 1 DAY 1
|
—
|
—
|
2.000 Hour
Interval 0.53 to 2.82
|
1.267 Hour
Interval 0.57 to 2.37
|
1.342 Hour
Interval 0.5 to 2.17
|
1.033 Hour
Interval 0.57 to 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax for Belantamab Mafodotin (Total Antibody), Treatment A
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
1.583 Hour
Interval 0.57 to 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 29; pre-dose Cycle 2 Day 28; pre-dose Cycle 3 Day 8Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tlast for Belantamab Mafodotin (Total Antibody), Treatment A
|
—
|
—
|
673.625 Hour
Interval 2.0 to 1534.15
|
657.267 Hour
Interval 25.5 to 1439.63
|
685.875 Hour
Interval 673.92 to 697.75
|
674.833 Hour
Interval 670.6 to 1416.93
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 5 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment A
CYCLE 1 DAY 1
|
—
|
—
|
3.16 ug/mL
Interval 1.6 to 5.9
|
0.81 ug/mL
Interval 0.6 to 2.0
|
3.39 ug/mL
Interval 0.7 to 6.1
|
7.74 ug/mL
Interval 1.9 to 9.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment A
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
3.99 ug/mL
Interval 0.9 to 12.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment A
WEEK 5 DAY 1
|
—
|
—
|
1.82 ug/mL
Interval 0.8 to 4.5
|
—
|
2.76 ug/mL
Interval 1.1 to 8.1
|
12.40 ug/mL
Interval 7.7 to 22.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment A
WEEK 5 DAY 8
|
—
|
—
|
—
|
—
|
—
|
6.16 ug/mL
Interval 2.5 to 22.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment A
WEEK 9 DAY 1
|
—
|
—
|
NA ug/mL
Interval 10.4 to 11.0
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 2.7 to 2.7
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 8.7 to 8.7
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
15.25 ug/mL
Interval 11.2 to 29.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment A
WEEK 9 DAY 8
|
—
|
—
|
—
|
—
|
—
|
10.50 ug/mL
Interval 1.3 to 10.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment A
WEEK 13 DAY 1
|
—
|
—
|
10.70 ug/mL
Interval 0.9 to 17.0
|
NA ug/mL
Interval 1.6 to 2.4
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
NA ug/mL
Interval 12.1 to 19.2
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment A
WEEK 13 DAY 8
|
—
|
—
|
—
|
—
|
—
|
NA ug/mL
Interval 10.5 to 10.5
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 5 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=10 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment A
CYCLE 1 DAY 1
|
—
|
—
|
47.00 ug/mL
Interval 17.2 to 64.2
|
42.70 ug/mL
Interval 35.0 to 64.0
|
36.90 ug/mL
Interval 35.3 to 47.9
|
27.25 ug/mL
Interval 20.1 to 32.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment A
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
35.00 ug/mL
Interval 27.8 to 40.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment A
WEEK 5 DAY 1
|
—
|
—
|
45.70 ug/mL
Interval 30.0 to 79.9
|
—
|
42.15 ug/mL
Interval 32.4 to 48.1
|
27.00 ug/mL
Interval 24.7 to 36.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment A
WEEK 5 DAY 8
|
—
|
—
|
—
|
—
|
—
|
36.40 ug/mL
Interval 27.8 to 50.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment A
WEEK 9 DAY 1
|
—
|
—
|
NA ug/mL
Interval 38.6 to 52.1
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
41.80 ug/mL
Interval 33.1 to 52.9
|
NA ug/mL
Interval 44.4 to 44.4
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
31.25 ug/mL
Interval 22.9 to 46.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment A
WEEK 9 DAY 8
|
—
|
—
|
—
|
—
|
—
|
39.20 ug/mL
Interval 27.4 to 56.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment A
WEEK 13 DAY 1
|
—
|
—
|
50.10 ug/mL
Interval 39.5 to 73.3
|
NA ug/mL
Interval 28.1 to 28.1
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
NA ug/mL
Interval 24.0 to 36.3
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment A
WEEK 13 DAY 8
|
—
|
—
|
—
|
—
|
—
|
NA ug/mL
Interval 32.3 to 44.8
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=10 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=17 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax for Belantamab Mafodotin (Total Antibody) Treatment B
CYCLE 1 DAY 1
|
—
|
—
|
53.85 ug/mL
Geometric Coefficient of Variation 12.54
|
41.28 ug/mL
Geometric Coefficient of Variation 16.86
|
37.47 ug/mL
Geometric Coefficient of Variation 12.02
|
53.29 ug/mL
Geometric Coefficient of Variation 23.50
|
22.92 ug/mL
Geometric Coefficient of Variation 35.83
|
50.32 ug/mL
Geometric Coefficient of Variation 30.03
|
31.06 ug/mL
Geometric Coefficient of Variation 20.02
|
78.29 ug/mL
Geometric Coefficient of Variation 36.16
|
—
|
—
|
|
Cmax for Belantamab Mafodotin (Total Antibody) Treatment B
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
29.47 ug/mL
Geometric Coefficient of Variation 40.48
|
—
|
45.31 ug/mL
Geometric Coefficient of Variation 39.57
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 21Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=6 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=8 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=6 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=8 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=7 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-504h) for Belantamab Mafodotin (Total Antibody), Treatment B
|
—
|
—
|
9891.43 h*ug/mL
Geometric Coefficient of Variation 29.93
|
7310.17 h*ug/mL
Geometric Coefficient of Variation 37.27
|
6094.55 h*ug/mL
Geometric Coefficient of Variation 33.37
|
8386.87 h*ug/mL
Geometric Coefficient of Variation 25.44
|
8283.76 h*ug/mL
Geometric Coefficient of Variation 32.51
|
8207.69 h*ug/mL
Geometric Coefficient of Variation 41.72
|
9812.19 h*ug/mL
Geometric Coefficient of Variation 27.13
|
12581.08 h*ug/mL
Geometric Coefficient of Variation 28.13
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 11; Cycle 1 Day 22; Pre-Dose and Post-Dose on Week 5 Day 7Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC(0-1008h) was derived only for Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex, Belantamab mafodotin 2.5 mg/kg StepDown STRETCH + Bor/Dex and Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex cohorts.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=5 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=10 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-1008h) for Belantamab Mafodotin (Total Antibody), Treatment B
|
—
|
—
|
—
|
11656.56 h*ug/mL
Geometric Coefficient of Variation 25.11
|
11328.37 h*ug/mL
Geometric Coefficient of Variation 40.25
|
11178.97 h*ug/mL
Geometric Coefficient of Variation 49.10
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=10 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=17 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax for Belantamab Mafodotin (Total Antibody), Treatment B
CYCLE 1 DAY 1
|
—
|
—
|
1.142 Hour
Interval 0.62 to 2.58
|
1.900 Hour
Interval 0.75 to 2.03
|
2.033 Hour
Interval 0.7 to 2.23
|
0.983 Hour
Interval 0.57 to 2.13
|
2.000 Hour
Interval 0.5 to 2.17
|
1.983 Hour
Interval 0.45 to 2.23
|
0.650 Hour
Interval 0.5 to 2.13
|
2.000 Hour
Interval 0.52 to 2.5
|
—
|
—
|
|
Tmax for Belantamab Mafodotin (Total Antibody), Treatment B
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
0.700 Hour
Interval 0.52 to 2.5
|
—
|
0.617 Hour
Interval 0.4 to 2.05
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 9 Day 1Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tlast for Belantamab Mafodotin (Total Antibody), Treatment B
|
—
|
—
|
1031.467 Hour
Interval 1006.72 to 4054.38
|
585.958 Hour
Interval 75.67 to 2855.48
|
504.983 Hour
Interval 239.92 to 2155.95
|
1414.500 Hour
Interval 505.25 to 3694.62
|
504.583 Hour
Interval 144.83 to 1351.17
|
505.483 Hour
Interval 167.5 to 671.65
|
502.883 Hour
Interval 239.72 to 717.68
|
506.808 Hour
Interval 2.0 to 2832.25
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=10 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=14 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=15 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment B
WEEK 7 DAY 1
|
—
|
—
|
2.32 ug/mL
Interval 1.9 to 5.8
|
NA ug/mL
Interval 2.7 to 5.7
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
7.66 ug/mL
Interval 2.6 to 22.2
|
1.72 ug/mL
Interval 1.4 to 6.5
|
19.40 ug/mL
Interval 10.3 to 34.0
|
1.35 ug/mL
Interval 1.1 to 21.7
|
26.00 ug/mL
Interval 19.1 to 31.0
|
—
|
—
|
—
|
|
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment B
CYCLE 1 DAY 1
|
—
|
—
|
1.32 ug/mL
Interval 0.6 to 8.6
|
3.13 ug/mL
Interval 1.0 to 5.6
|
5.27 ug/mL
Interval 2.1 to 10.7
|
1.53 ug/mL
Interval 1.1 to 4.5
|
5.88 ug/mL
Interval 1.2 to 13.5
|
7.22 ug/mL
Interval 1.7 to 17.2
|
9.59 ug/mL
Interval 3.5 to 38.9
|
6.82 ug/mL
Interval 1.4 to 17.4
|
—
|
—
|
|
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment B
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
12.30 ug/mL
Interval 2.7 to 33.2
|
—
|
12.05 ug/mL
Interval 7.8 to 22.6
|
—
|
—
|
—
|
|
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment B
WEEK 4 DAY 1
|
—
|
—
|
—
|
—
|
7.97 ug/mL
Interval 0.6 to 18.8
|
—
|
14.95 ug/mL
Interval 1.2 to 27.7
|
3.62 ug/mL
Interval 0.6 to 22.8
|
11.20 ug/mL
Interval 5.3 to 25.1
|
5.27 ug/mL
Interval 1.9 to 13.2
|
—
|
—
|
|
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment B
WEEK 7 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
NA ug/mL
Interval 1.5 to 1.5
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment B
WEEK 10 DAY 1
|
—
|
—
|
NA ug/mL
Interval 2.3 to 2.3
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
3.07 ug/mL
Interval 1.4 to 3.4
|
NA ug/mL
Interval 16.6 to 16.6
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
NA ug/mL
Interval 20.7 to 20.7
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 23.0 to 23.0
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
|
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment B
WEEK 13 DAY 1
|
—
|
—
|
NA ug/mL
Interval 9.3 to 14.5
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 12.0 to 12.0
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
5.26 ug/mL
Interval 1.3 to 10.5
|
—
|
NA ug/mL
Interval 32.3 to 32.3
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 29.2 to 29.2
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 10.0 to 18.9
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
|
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment B
WEEK 13 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA ug/mL
Interval 10.0 to 10.0
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 7 Day 11, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=11 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=15 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment B
CYCLE 1 DAY 1
|
—
|
—
|
51.65 ug/mL
Interval 43.7 to 66.1
|
36.60 ug/mL
Interval 30.7 to 52.0
|
36.75 ug/mL
Interval 27.6 to 44.0
|
52.55 ug/mL
Interval 38.2 to 90.3
|
23.90 ug/mL
Interval 13.9 to 33.1
|
44.35 ug/mL
Interval 30.3 to 63.0
|
33.40 ug/mL
Interval 21.2 to 40.1
|
68.80 ug/mL
Interval 42.5 to 241.0
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment B
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
24.95 ug/mL
Interval 16.1 to 38.2
|
—
|
42.50 ug/mL
Interval 25.7 to 98.9
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment B
WEEK 4 DAY 1
|
—
|
—
|
—
|
—
|
39.20 ug/mL
Interval 24.6 to 54.6
|
—
|
37.00 ug/mL
Interval 19.8 to 46.0
|
59.50 ug/mL
Interval 30.1 to 233.0
|
39.40 ug/mL
Interval 19.6 to 70.8
|
67.85 ug/mL
Interval 50.0 to 85.5
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment B
WEEK 7 DAY 1
|
—
|
—
|
47.50 ug/mL
Interval 33.3 to 67.7
|
36.50 ug/mL
Interval 31.8 to 67.8
|
43.00 ug/mL
Interval 14.3 to 78.6
|
37.30 ug/mL
Interval 23.3 to 65.1
|
42.00 ug/mL
Interval 24.0 to 49.5
|
50.75 ug/mL
Interval 29.6 to 73.8
|
33.90 ug/mL
Interval 20.2 to 63.0
|
63.95 ug/mL
Interval 44.5 to 67.6
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment B
WEEK 7 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
NA ug/mL
Interval 32.2 to 60.4
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
NA ug/mL
Interval 46.5 to 82.0
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment B
WEEK 7 DAY 11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA ug/mL
Interval 34.9 to 34.9
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment B
WEEK 10 DAY 1
|
—
|
—
|
NA ug/mL
Interval 64.6 to 64.6
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
42.70 ug/mL
Interval 41.0 to 53.6
|
NA ug/mL
Interval 31.6 to 44.2
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
NA ug/mL
Interval 36.9 to 36.9
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 61.1 to 61.1
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment B
WEEK 10 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
NA ug/mL
Interval 40.7 to 40.7
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment B
WEEK 13 DAY 1
|
—
|
—
|
NA ug/mL
Interval 68.4 to 72.8
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 37.0 to 37.0
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 29.6 to 29.6
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
33.30 ug/mL
Interval 27.8 to 41.6
|
—
|
NA ug/mL
Interval 37.6 to 51.2
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 49.5 to 49.5
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
54.50 ug/mL
Interval 52.9 to 85.3
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment B
WEEK 13 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA ug/mL
Interval 48.0 to 48.0
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=11 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax for Belantamab Mafodotin Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF), Treatment A
CYCLE 1 DAY 1
|
—
|
—
|
1.18 ug/mL
Geometric Coefficient of Variation 53.35
|
1.11 ug/mL
Geometric Coefficient of Variation 70.59
|
0.55 ug/mL
Geometric Coefficient of Variation 53.90
|
0.53 ug/mL
Geometric Coefficient of Variation 48.23
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax for Belantamab Mafodotin Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF), Treatment A
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
0.63 ug/mL
Geometric Coefficient of Variation 28.28
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0, 2, and 24 Hours Post Dose on Cycle 1 Day 1, and Cycle 1 Day 8Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=10 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=9 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=1 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-168h) for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
CYCLE 1 DAY 1
|
—
|
—
|
113.58 h*ug/mL
Geometric Coefficient of Variation 49.61
|
106.21 h*ug/mL
Geometric Coefficient of Variation 55.99
|
NA h*ug/mL
Geometric Coefficient of Variation NA
As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
|
43.15 h*ug/mL
Geometric Coefficient of Variation 26.42
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUC (0-168h) for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
51.31 h*ug/mL
Geometric Coefficient of Variation 30.45
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0, 2, and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 14Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC (0-336h) was derived only for the Belantamab mafodotin 2.5mg/kg + Len/Dex SPLIT cohort.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=8 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-336h) for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
|
—
|
—
|
—
|
93.84 h*ug/mL
Geometric Coefficient of Variation 29.16
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=11 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
CYCLE 1 DAY 1
|
—
|
—
|
24.367 Hour
Interval 2.23 to 25.92
|
24.217 Hour
Interval 1.42 to 28.58
|
24.900 Hour
Interval 23.67 to 73.42
|
23.667 Hour
Interval 1.0 to 25.42
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
23.425 Hour
Interval 0.57 to 25.93
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 1 Day 15Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=14 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tlast for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
|
—
|
—
|
166.167 Hour
Interval 2.08 to 239.17
|
165.567 Hour
Interval 25.5 to 357.02
|
120.283 Hour
Interval 49.97 to 191.58
|
336.900 Hour
Interval 94.4 to 360.17
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 7 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=14 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=11 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
CYCLE 1 DAY 1
|
—
|
—
|
0.29 ug/mL
Interval 0.1 to 1.3
|
0.43 ug/mL
Interval 0.3 to 1.6
|
0.187 ug/mL
Interval 0.16 to 0.29
|
0.19 ug/mL
Interval 0.1 to 1.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
0.29 ug/mL
Interval 0.2 to 0.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
WEEK 5 DAY 1
|
—
|
—
|
0.28 ug/mL
Interval 0.2 to 1.0
|
—
|
0.16 ug/mL
Interval 0.1 to 0.4
|
0.13 ug/mL
Interval 0.1 to 0.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
WEEK 7 DAY 8
|
—
|
—
|
—
|
—
|
—
|
0.23 ug/mL
Interval 0.2 to 0.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
WEEK 9 DAY 1
|
—
|
—
|
NA ug/mL
Interval 0.2 to 0.2
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
0.29 ug/mL
Interval 0.2 to 0.5
|
NA ug/mL
Interval 0.1 to 0.1
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
0.13 ug/mL
Interval 0.1 to 0.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
WEEK 9 DAY 8
|
—
|
—
|
—
|
—
|
—
|
0.24 ug/mL
Interval 0.2 to 0.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
WEEK 13 DAY 1
|
—
|
—
|
0.68 ug/mL
Interval 0.2 to 0.9
|
NA ug/mL
Interval 0.4 to 0.4
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
NA ug/mL
Interval 0.1 to 0.2
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
WEEK 13 DAY 8
|
—
|
—
|
—
|
—
|
—
|
0.243 ug/mL
Interval 0.207 to 0.248
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=10 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax for Belantamab Mafodotin (Cys-mcMMAF) Treatment B
CYCLE 1 DAY 1
|
—
|
—
|
1.29 ug/mL
Geometric Coefficient of Variation 38.95
|
0.73 ug/mL
Geometric Coefficient of Variation 29.88
|
0.75 ug/mL
Geometric Coefficient of Variation 68.94
|
1.03 ug/mL
Geometric Coefficient of Variation 52.77
|
0.65 ug/mL
Geometric Coefficient of Variation 87.99
|
1.15 ug/mL
Geometric Coefficient of Variation 57.18
|
1.03 ug/mL
Geometric Coefficient of Variation 38.56
|
1.09 ug/mL
Geometric Coefficient of Variation 40.30
|
—
|
—
|
|
Cmax for Belantamab Mafodotin (Cys-mcMMAF) Treatment B
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
0.58 ug/mL
Geometric Coefficient of Variation 87.48
|
—
|
0.86 ug/mL
Geometric Coefficient of Variation 64.55
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0, 2, and 24 Hours Post Dose on Cycle 1 Day 1, Cycle 1 Day 4; and Cycle 1 Day 7Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=8 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=10 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-168h) for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
|
—
|
—
|
—
|
—
|
—
|
89.05 h*ug/mL
Geometric Coefficient of Variation 41.52
|
52.82 h*ug/mL
Geometric Coefficient of Variation 96.74
|
—
|
81.17 h*ug/mL
Geometric Coefficient of Variation 31.46
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=10 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
CYCLE 1 DAY 1
|
—
|
—
|
22.442 Hour
Interval 1.17 to 74.02
|
22.225 Hour
Interval 22.07 to 24.77
|
24.475 Hour
Interval 1.0 to 25.75
|
23.092 Hour
Interval 22.0 to 25.95
|
24.083 Hour
Interval 19.3 to 77.37
|
24.083 Hour
Interval 2.07 to 25.25
|
24.583 Hour
Interval 22.97 to 70.28
|
24.667 Hour
Interval 21.85 to 25.72
|
—
|
—
|
|
Tmax for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
24.000 Hour
Interval 0.92 to 25.3
|
—
|
23.717 Hour
Interval 2.58 to 25.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 2 Day 1Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tlast for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
|
—
|
—
|
93.942 Hour
Interval 67.95 to 242.77
|
85.542 Hour
Interval 68.57 to 262.25
|
239.800 Hour
Interval 72.33 to 243.9
|
237.992 Hour
Interval 70.58 to 265.82
|
241.283 Hour
Interval 146.33 to 527.5
|
237.425 Hour
Interval 70.53 to 241.58
|
240.675 Hour
Interval 237.55 to 503.73
|
171.567 Hour
Interval 2.0 to 266.87
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 7 Day 11, Week 10 Day 1, Week 10 Day 8, Week 13 Day 1, Week 13 Day 8Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=17 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=15 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
WEEK 4 DAY 1
|
—
|
—
|
—
|
—
|
0.19 ug/mL
Interval 0.1 to 0.4
|
—
|
0.21 ug/mL
Interval 0.1 to 0.4
|
0.35 ug/mL
Interval 0.1 to 1.5
|
0.26 ug/mL
Interval 0.2 to 0.6
|
0.35 ug/mL
Interval 0.2 to 0.9
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
WEEK 7 DAY 1
|
—
|
—
|
0.31 ug/mL
Interval 0.1 to 0.9
|
0.20 ug/mL
Interval 0.1 to 0.4
|
0.21 ug/mL
Interval 0.1 to 0.3
|
0.17 ug/mL
Interval 0.1 to 0.2
|
0.27 ug/mL
Interval 0.1 to 0.4
|
0.24 ug/mL
Interval 0.1 to 0.9
|
0.20 ug/mL
Interval 0.2 to 0.4
|
0.36 ug/mL
Interval 0.2 to 0.4
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
CYCLE 1 DAY 1
|
—
|
—
|
0.32 ug/mL
Interval 0.1 to 1.4
|
0.29 ug/mL
Interval 0.1 to 0.5
|
0.21 ug/mL
Interval 0.1 to 2.7
|
0.28 ug/mL
Interval 0.2 to 0.6
|
0.19 ug/mL
Interval 0.1 to 0.7
|
0.29 ug/mL
Interval 0.1 to 0.8
|
0.27 ug/mL
Interval 0.1 to 0.8
|
0.39 ug/mL
Interval 0.2 to 0.6
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
CYCLE 1 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
0.27 ug/mL
Interval 0.1 to 1.5
|
—
|
0.40 ug/mL
Interval 0.2 to 0.9
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
WEEK 7 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
NA ug/mL
Interval 0.2 to 0.3
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
NA ug/mL
Interval 0.3 to 0.6
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
WEEK 7 DAY 11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA ug/mL
Interval 5.0 to 5.0
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
WEEK 10 DAY 1
|
—
|
—
|
NA ug/mL
Interval 0.5 to 0.5
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
0.236 ug/mL
Interval 0.188 to 0.238
|
NA ug/mL
Interval 0.2 to 0.4
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
NA ug/mL
Interval 0.3 to 0.3
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 0.4 to 0.4
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
WEEK 10 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
NA ug/mL
Interval 1.6 to 1.6
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
WEEK 13 DAY 1
|
—
|
—
|
NA ug/mL
Interval 0.4 to 0.4
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 0.1 to 0.4
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
0.222 ug/mL
Interval 0.118 to 0.24
|
—
|
NA ug/mL
Interval 0.2 to 0.6
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
NA ug/mL
Interval 0.3 to 0.3
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
0.24 ug/mL
Interval 0.1 to 0.3
|
—
|
—
|
|
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
WEEK 13 DAY 8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA ug/mL
Interval 0.3 to 0.3
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dosePopulation: Pharmacokinetic (PK) population. Only those participants who received 25 mg lenalidomide with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=5 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax for Lenalidomide (25 mg), Treatment A
|
—
|
—
|
283.08 ug/mL
Geometric Coefficient of Variation 36.55
|
382.16 ug/mL
Geometric Coefficient of Variation 54.52
|
331.53 ug/mL
Geometric Coefficient of Variation 17.91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dosePopulation: Pharmacokinetic (PK) population. Only those participants who received 25 mg lenalidomide with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=8 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=3 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-24h) for Lenalidomide (25 mg), Treatment A
|
—
|
—
|
2117.26 h*ug/mL
Geometric Coefficient of Variation 38.21
|
2247.36 h*ug/mL
Geometric Coefficient of Variation 65.76
|
1577.62 h*ug/mL
Geometric Coefficient of Variation 21.66
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0.5, 1, 2 and 4 hours on Cycle 1 Day 1 post lenalidomide dosePopulation: Pharmacokinetic (PK) population. Only those participants who received 25 mg lenalidomide with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=5 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=3 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-4h) for Lenalidomide (25 mg), Treatment A
|
—
|
—
|
620.10 h*ug/mL
Geometric Coefficient of Variation 44.84
|
812.22 h*ug/mL
Geometric Coefficient of Variation 105.88
|
870.92 h*ug/mL
Geometric Coefficient of Variation 19.36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dosePopulation: Pharmacokinetic (PK) population. Only those participants who received 25 mg lenalidomide with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=5 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax for Lenalidomide (25 mg), Treatment A
|
—
|
—
|
3.767 Hour
Interval 1.92 to 4.0
|
0.967 Hour
Interval 0.47 to 4.0
|
1.417 Hour
Interval 0.93 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, Post dose on Cycle 1 Day 1Population: Pharmacokinetic (PK) population. Only those participants who received 25 mg lenalidomide with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=5 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tlast for Lenalidomide (25 mg), Treatment A
|
—
|
—
|
22.050 Hour
Interval 3.75 to 23.55
|
20.750 Hour
Interval 3.8 to 24.0
|
4.000 Hour
Interval 3.77 to 22.57
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dosePopulation: Pharmacokinetic (PK) population. Only those participants who received 10 mg lenalidomide with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=2 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax for Lenalidomide (10 mg), Treatment A
|
—
|
—
|
NA ug/mL
Geometric Coefficient of Variation NA
As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
|
193.06 ug/mL
Geometric Coefficient of Variation 36.86
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dosePopulation: Pharmacokinetic (PK) population. Only those participants who received 10 mg lenalidomide with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=1 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-24h) for Lenalidomide (10 mg), Treatment A
|
—
|
—
|
NA h*ug/mL
Geometric Coefficient of Variation NA
As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
|
1660.82 h*ug/mL
Geometric Coefficient of Variation 22.40
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0.5, 1, 2 and 4 hours on Cycle 1 Day 1 post lenalidomide dosePopulation: Pharmacokinetic (PK) population. Only those participants who received 10 mg lenalidomide with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=2 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-4h) for Lenalidomide (10 mg), Treatment A
|
—
|
—
|
NA h*ug/mL
Geometric Coefficient of Variation NA
As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
|
486.46 h*ug/mL
Geometric Coefficient of Variation 41.84
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dosePopulation: Pharmacokinetic (PK) population. Only those participants who received 10 mg lenalidomide with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=2 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax for Lenalidomide (10 mg), Treatment A
|
—
|
—
|
NA Hour
Interval 1.13 to 4.0
As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
|
2.000 Hour
Interval 0.53 to 3.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, Post dose on Cycle 1 Day 1Population: Pharmacokinetic (PK) population. Only those participants who received 10 mg lenalidomide with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=2 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tlast for Lenalidomide (10 mg), Treatment A
|
—
|
—
|
NA Hour
Interval 4.0 to 4.0
As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
|
21.583 Hour
Interval 21.27 to 23.68
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, 0.5, 1, 2, 4 and 24 Hours Post-Dose on Cycle 1 Day 1Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points for Bortezomib have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=15 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=15 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax for Bortezomib, Treatment B
INTRAVENOUS
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA ug/mL
Geometric Coefficient of Variation NA
As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
|
—
|
NA ug/mL
Geometric Coefficient of Variation NA
As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
|
Cmax for Bortezomib, Treatment B
SUBCUTANEOUS
|
—
|
—
|
—
|
—
|
14.45 ug/mL
Geometric Coefficient of Variation 50.16
|
—
|
—
|
14.89 ug/mL
Geometric Coefficient of Variation 44.03
|
—
|
15.88 ug/mL
Geometric Coefficient of Variation 42.07
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minute, 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48 and 72 hour post bortezomib dosePopulation: Pharmacokinetic (PK) population. Only those participants who received Bortezomib with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=14 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-72h) for Bortezomib, Treatment B
Intravenous
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA h*ug/mL
Geometric Coefficient of Variation NA
As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
|
—
|
NA h*ug/mL
Geometric Coefficient of Variation NA
As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
|
AUC (0-72h) for Bortezomib, Treatment B
Subcutaneous
|
—
|
—
|
—
|
—
|
95.10 h*ug/mL
Geometric Coefficient of Variation 21.71
|
—
|
—
|
73.03 h*ug/mL
Geometric Coefficient of Variation 30.79
|
—
|
73.06 h*ug/mL
Geometric Coefficient of Variation 21.57
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minute, 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48 and 72 hour post bortezomib dosePopulation: Pharmacokinetic (PK) population. Only those participants who received Bortezomib with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=15 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=15 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-t) for Bortezomib, Treatment B
Intravenous
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA h*ug/mL
Geometric Coefficient of Variation NA
As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
|
—
|
NA h*ug/mL
Geometric Coefficient of Variation NA
As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
|
AUC (0-t) for Bortezomib, Treatment B
Subcutaneous
|
—
|
—
|
—
|
—
|
89.48 h*ug/mL
Geometric Coefficient of Variation 25.50
|
—
|
—
|
69.51 h*ug/mL
Geometric Coefficient of Variation 31.87
|
—
|
71.70 h*ug/mL
Geometric Coefficient of Variation 26.79
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minute, 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48 and 72 hour post bortezomib dosePopulation: Pharmacokinetic (PK) population. Only those participants who received Bortezomib with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=15 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=15 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax for Bortezomib, Treatment B
Intravenous
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Hour
Interval 0.08 to 0.08
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
NA Hour
Interval 0.13 to 0.13
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
|
Tmax for Bortezomib, Treatment B
Subcutaneous
|
—
|
—
|
—
|
—
|
0.533 Hour
Interval 0.1 to 1.07
|
—
|
—
|
0.517 Hour
Interval 0.25 to 1.0
|
—
|
0.500 Hour
Interval 0.08 to 1.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose, Post dose on Cycle 1 Day 3Population: Pharmacokinetic (PK) population. Only those participants who received Bortezomib with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=1 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=15 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tlast for Bortezomib, Treatment B
Intravenous
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Hour
Interval 46.97 to 46.97
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
NA Hour
Interval 70.52 to 70.52
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
—
|
—
|
|
Tlast for Bortezomib, Treatment B
Subcutaneous
|
—
|
—
|
—
|
—
|
68.867 Hour
Interval 44.07 to 72.0
|
—
|
NA Hour
Interval 73.07 to 73.07
As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
|
68.392 Hour
Interval 44.35 to 73.1
|
—
|
48.000 Hour
Interval 46.17 to 75.65
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 4.5 years (End of Treatment [EoT])Population: All Treated. Only those participants with data available at specified time points have been analyzed.
Serum samples were collected and tested for the presence of antibodies against belantamab mafodotin using validated immunoassays.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=15 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=3 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
Baseline (Day 1)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
EoT (Up to approx. 4.5 years)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 4.5 yearsPopulation: All Treated. Only those participants with data available at specified time points have been analyzed. There were no participants with positive ADA results at end of treatment. Hence the titer (concentration) of ADA was not collected.
Serum samples were collected and tested for the presence of antibodies against belantamab mafodotin using validated immunoassays. Confirmed positive ADA samples were further analyzed to obtain the titer of the antibodies. Titers of anti-drug antibodies against belantamab mafodotin is presented.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=1 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=1 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=1 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Titers of ADAs Against Belantamab Mafodotin
|
100 Titers
Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual titer value for this single participant.
|
—
|
100 Titers
Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual titer value for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
100 Titers
Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual titer value for this single participant.
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to approximately 4.5 yearsPopulation: All Treated. Only those participants with data available at specified time points have been analyzed.
The OSDI is a 12-item questionnaire designed to assess both the frequency of dry eye symptoms and their impact on vision-related functioning. OSDI consist of three subscales (ocular symptoms: item 1-3; visual related function: item 4-9; environmental triggers: item 10-12). Each item will be graded on a scale of 0 (none of the time or lower disability) to 4 (all of the time or greater disability) with total scores ranging from 0 (no disability) to 100 (complete disability). The total OSDI score was calculated as (sum of scores for all questions answered\*100) divided by (total number of questions answered\*4). Higher scores indicated greater disability. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=14 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=9 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=10 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=15 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Scores
Baseline (Day 1)
|
8.6 Score on scale
Standard Deviation 13.61
|
3.3 Score on scale
Standard Deviation 5.58
|
11.4 Score on scale
Standard Deviation 14.26
|
11.1 Score on scale
Standard Deviation 7.58
|
0.8 Score on scale
Standard Deviation 1.56
|
7.8 Score on scale
Standard Deviation 9.30
|
10.8 Score on scale
Standard Deviation 17.20
|
2.4 Score on scale
Standard Deviation 2.79
|
7.8 Score on scale
Standard Deviation 9.94
|
8.0 Score on scale
Standard Deviation 5.66
|
12.4 Score on scale
Standard Deviation 16.42
|
6.3 Score on scale
Standard Deviation 7.71
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Scores
Change from baseline (up to approx. 4.5 years)
|
48.3 Score on scale
Standard Deviation 27.42
|
19.3 Score on scale
Standard Deviation 14.41
|
2.2 Score on scale
Standard Deviation 7.19
|
-5.2 Score on scale
Standard Deviation 4.42
|
0.6 Score on scale
Standard Deviation 4.10
|
6.9 Score on scale
Standard Deviation 12.03
|
15.2 Score on scale
Standard Deviation 35.94
|
15.9 Score on scale
Standard Deviation 14.80
|
18.7 Score on scale
Standard Deviation 34.95
|
29.3 Score on scale
Standard Deviation 39.18
|
6.1 Score on scale
Standard Deviation 8.59
|
14.4 Score on scale
Standard Deviation 23.26
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to approximately 4.5 yearsPopulation: All Treated. Only those participants with data available at specified time points have been analyzed.
The NEI-VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question to assess the patient's perception of vision-related functioning and vision-related quality of life. Items were coded to a 0 to 100 scale and were averaged to calculate domains. The composite score ranges from 0 (worst score) to 100 (best score), with higher scores indicating better vision-related functioning. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=7 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=10 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=10 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=3 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=8 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=8 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=7 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Scores
Baseline (Day 1)
|
93.2 Score on scale
Standard Deviation 7.13
|
94.7 Score on scale
Standard Deviation 5.59
|
91.0 Score on scale
Standard Deviation 11.35
|
85.1 Score on scale
Standard Deviation 11.42
|
89.0 Score on scale
Standard Deviation 18.43
|
91.9 Score on scale
Standard Deviation 10.88
|
88.0 Score on scale
Standard Deviation 16.92
|
95.5 Score on scale
Standard Deviation 4.70
|
96.2 Score on scale
Standard Deviation 5.20
|
95.3 Score on scale
Standard Deviation 4.60
|
90.4 Score on scale
Standard Deviation 7.67
|
94.1 Score on scale
Standard Deviation 8.33
|
|
Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Scores
Change from baseline (up to approx. 4.5 years)
|
-48.9 Score on scale
Standard Deviation 2.35
|
-11.5 Score on scale
Standard Deviation 15.39
|
-1.9 Score on scale
Standard Deviation 3.43
|
0.2 Score on scale
Standard Deviation 13.53
|
12.9 Score on scale
Standard Deviation 22.42
|
-4.5 Score on scale
Standard Deviation 4.04
|
1.1 Score on scale
Standard Deviation 19.48
|
-8.4 Score on scale
Standard Deviation 13.65
|
-18.3 Score on scale
Standard Deviation 19.96
|
-26.0 Score on scale
Standard Deviation 31.54
|
1.3 Score on scale
|
-13.2 Score on scale
Standard Deviation 25.00
|
SECONDARY outcome
Timeframe: Up to approximately 4.5 yearsPopulation: All Treated.
The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. It included item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE like Anxious, Blurred Vision, Chills, Concentration, Constipation, Cough, Decreased Appetite, Discouraged, Dizziness, Fatigue, Heart Palpitations, Insomnia, Memory, Mouth/Throat Sores, Nausea, Nosebleed, Numbness \& Tingling, Pain, Ringing In Ears, Shortness Of Breath, Vomiting and Watery Eyes. Number of participants with symptomatic AEs measured by PRO-CTCAEs are presented.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nausea
|
10 Participants
|
15 Participants
|
13 Participants
|
8 Participants
|
4 Participants
|
13 Participants
|
8 Participants
|
12 Participants
|
12 Participants
|
11 Participants
|
11 Participants
|
17 Participants
|
|
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Nosebleed
|
10 Participants
|
15 Participants
|
13 Participants
|
8 Participants
|
4 Participants
|
13 Participants
|
8 Participants
|
12 Participants
|
12 Participants
|
11 Participants
|
11 Participants
|
17 Participants
|
|
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Cough
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Decreased Appetite
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Mouth/Throat Sores
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Numbness & tingling
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Pain
|
10 Participants
|
15 Participants
|
13 Participants
|
8 Participants
|
4 Participants
|
13 Participants
|
8 Participants
|
12 Participants
|
12 Participants
|
11 Participants
|
11 Participants
|
17 Participants
|
|
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Ringing In Ears
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Shortness Of Breath
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Vomiting
|
10 Participants
|
15 Participants
|
13 Participants
|
8 Participants
|
4 Participants
|
13 Participants
|
8 Participants
|
12 Participants
|
12 Participants
|
11 Participants
|
11 Participants
|
17 Participants
|
|
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Watery Eyes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Concentration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Constipation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Anxious
|
10 Participants
|
15 Participants
|
13 Participants
|
8 Participants
|
4 Participants
|
13 Participants
|
8 Participants
|
12 Participants
|
12 Participants
|
11 Participants
|
11 Participants
|
17 Participants
|
|
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Blurred Vision
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Chills
|
10 Participants
|
15 Participants
|
13 Participants
|
8 Participants
|
4 Participants
|
13 Participants
|
8 Participants
|
12 Participants
|
12 Participants
|
11 Participants
|
11 Participants
|
17 Participants
|
|
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Discouraged
|
10 Participants
|
15 Participants
|
13 Participants
|
8 Participants
|
4 Participants
|
13 Participants
|
8 Participants
|
12 Participants
|
12 Participants
|
11 Participants
|
11 Participants
|
17 Participants
|
|
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Fatigue
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Dizziness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Heart Palpitations
|
10 Participants
|
15 Participants
|
13 Participants
|
8 Participants
|
4 Participants
|
13 Participants
|
8 Participants
|
12 Participants
|
12 Participants
|
11 Participants
|
11 Participants
|
17 Participants
|
|
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Insomnia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Memory
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 4.5 yearsPopulation: All Treated population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with AESI for belantamab mafodotin (corneal events, thrombocytopenia and infusion related reactions) are presented.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With AEs of Special Interest (AESI)
AESI (Corneal Events)
|
10 Participants
|
16 Participants
|
11 Participants
|
9 Participants
|
3 Participants
|
12 Participants
|
9 Participants
|
12 Participants
|
12 Participants
|
12 Participants
|
10 Participants
|
17 Participants
|
|
Number of Participants With AEs of Special Interest (AESI)
AESI (Infusion Related Reactions)
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With AEs of Special Interest (AESI)
AESI (Thrombocytopenia)
|
12 Participants
|
14 Participants
|
11 Participants
|
4 Participants
|
2 Participants
|
7 Participants
|
9 Participants
|
12 Participants
|
10 Participants
|
11 Participants
|
11 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to approximately 4.5 yearsPopulation: All Treated. Only those participants with data available at specified time points have been analyzed.
BCVA score was assessed individually for each eye. BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any worst-case change from baseline categories are presented for right and left eyes. BCVA test scores were categorized as no change/improved vision, possible worsened vision and definite worsened vision. No change/improved vision was defined as a change from baseline \<0.12 logMAR score; a possible worsened vision was defined as a change from baseline \>=0.12 to \<0.3 logMAR score; a definite worsened vision was defined as a change from baseline \>=0.3 logMAR score. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=14 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=9 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores
Right Eye, No change/improved vision
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores
Right Eye, Possible worsened vision
|
5 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores
Right Eye, Definite worsened vision
|
4 Participants
|
10 Participants
|
9 Participants
|
4 Participants
|
2 Participants
|
8 Participants
|
5 Participants
|
7 Participants
|
10 Participants
|
6 Participants
|
6 Participants
|
13 Participants
|
|
Number of Participants With Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores
Left Eye, Possible worsened vision
|
2 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores
Left Eye, No change/improved vision
|
3 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores
Left Eye, Definite worsened vision
|
6 Participants
|
8 Participants
|
9 Participants
|
5 Participants
|
3 Participants
|
9 Participants
|
7 Participants
|
8 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to approximately 4.5 yearsPopulation: All Treated. Only those participants with data available at specified time points have been analyzed.
BCVA score was assessed individually for better seeing eye and worse seeing eye. BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any worst-case change post baseline categories are presented for better seeing eye and worse seeing eye. BCVA test scores by Snellen results were categorized as improved BCVA, \<= 2 lines decline in visual acuity from baseline, \>= 3 lines decline in visual acuity from baseline. Number of lines change from baseline was defined as the following: Improved BCVA equates to a negative change in logMAR from baseline BCVA. \<= 2 lines decline in visual acuity equates to logMAR change from baseline ≤0.37. \>= 3 lines decline in visual acuity equates to logMAR change from baseline ≥0.38. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=14 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=9 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst-case Post-baseline Change in BCVA Scores by Snellen Results
Better seeing Eye, Improved BCVA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Post-baseline Change in BCVA Scores by Snellen Results
Better seeing Eye, <=2 Lines decline in visual acuity from baseline
|
9 Participants
|
12 Participants
|
11 Participants
|
8 Participants
|
3 Participants
|
9 Participants
|
7 Participants
|
7 Participants
|
10 Participants
|
8 Participants
|
9 Participants
|
8 Participants
|
|
Number of Participants With Worst-case Post-baseline Change in BCVA Scores by Snellen Results
Better seeing Eye, >=3 Lines decline in visual acuity from baseline
|
2 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
9 Participants
|
|
Number of Participants With Worst-case Post-baseline Change in BCVA Scores by Snellen Results
Worse seeing Eye, Improved BCVA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Post-baseline Change in BCVA Scores by Snellen Results
Worse seeing Eye, <=2 Lines decline in visual acuity from baseline
|
7 Participants
|
8 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
8 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Worst-case Post-baseline Change in BCVA Scores by Snellen Results
Worse seeing Eye, >=3 Lines decline in visual acuity from baseline
|
4 Participants
|
8 Participants
|
9 Participants
|
4 Participants
|
1 Participants
|
8 Participants
|
4 Participants
|
7 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to approximately 4.5 yearsPopulation: All Treated. Only those participants with data available at specified time points have been analyzed.
Number of participants with a Decline in BCVA to 'Light Perception (LP)' or 'No Light Perception (NLP)' due to a Corneal Event Anytime Post-Baseline are presented. BCVA score was assessed individually for each eye (Left and Right). Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Number of participants analyzed were who have any post-baseline BCVA score, where the Visual Acuity is due to corneal findings.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=8 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=10 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=9 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=3 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=10 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=10 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=8 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Post-baseline Decline in BCVA to Light Perception or no Light Perception
Right Eye, LP
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Post-baseline Decline in BCVA to Light Perception or no Light Perception
Left Eye, LP
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Post-baseline Decline in BCVA to Light Perception or no Light Perception
Left Eye, NLP
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Post-baseline Decline in BCVA to Light Perception or no Light Perception
Right Eye, NLP
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to approximately 4.5 yearsPopulation: All Treated. Only those participants with data available at specified time points have been analyzed.
Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Corneal epithelium findings like active edema, active opacity, corneal neovascularization (CN), corneal ulcer, epithelial microcystic edema (EME) and subepithelial haze were performed using a slit lamp. Number of participants with shift in corneal epithelium findings from no (Baseline) to yes (worst post-Baseline) are presented.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)
Corneal Ulcer, Left Eye
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)
Epithelial Microcystic Edema, Right Eye
|
3 Participants
|
9 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
9 Participants
|
|
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)
Active Edema, Right Eye
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)
Active Edema, Left Eye
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)
Active Opacity, Right Eye
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)
Active Opacity, Left Eye
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)
Corneal Neovascularization, Right Eye
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)
Corneal Neovascularization, Left Eye
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)
Corneal Ulcer, Right Eye
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)
Epithelial Microcystic Edema, Left Eye
|
3 Participants
|
9 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
8 Participants
|
|
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)
Subepithelial Haze, Right Eye
|
8 Participants
|
9 Participants
|
8 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
8 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
9 Participants
|
|
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)
Subepithelial Haze, Left Eye
|
8 Participants
|
10 Participants
|
9 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
9 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to approximately 4.5 yearsPopulation: All Treated. Only those participants with data available at specified time points have been analyzed.
Participants with worse grade punctate keratopathy findings post baseline at any ocular exam by right eye, left eye and worse eye are presented as none, mild, moderate and severe. Worse eye indicates the eye with the worst visual acuity. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=16 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=14 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=9 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=18 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Worse Grade Post-baseline Punctate Keratopathy Findings
Right Eye, None
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Worse Grade Post-baseline Punctate Keratopathy Findings
Left Eye, Moderate
|
6 Participants
|
10 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
7 Participants
|
9 Participants
|
|
Number of Participants With Worse Grade Post-baseline Punctate Keratopathy Findings
Left Eye, Severe
|
2 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants With Worse Grade Post-baseline Punctate Keratopathy Findings
Worst eye, None
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Worse Grade Post-baseline Punctate Keratopathy Findings
Worst eye, Mild
|
2 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Worse Grade Post-baseline Punctate Keratopathy Findings
Worst eye, Moderate
|
6 Participants
|
9 Participants
|
6 Participants
|
6 Participants
|
2 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
10 Participants
|
|
Number of Participants With Worse Grade Post-baseline Punctate Keratopathy Findings
Worst eye, Severe
|
2 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Worse Grade Post-baseline Punctate Keratopathy Findings
Right Eye, Severe
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Worse Grade Post-baseline Punctate Keratopathy Findings
Left Eye, None
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Worse Grade Post-baseline Punctate Keratopathy Findings
Left Eye, Mild
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Worse Grade Post-baseline Punctate Keratopathy Findings
Right Eye, Mild
|
2 Participants
|
2 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Worse Grade Post-baseline Punctate Keratopathy Findings
Right Eye, Moderate
|
6 Participants
|
9 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
7 Participants
|
4 Participants
|
7 Participants
|
5 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to approximately 4.5 years (End of treatment [EoT])Population: All Treated. Only those participants with data available at specified time points have been analyzed.
The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning \[PF\], role functioning \[RF\], cognitive functioning \[CF\], emotional functioning \[EF\] and social functioning \[SF\]), three symptom scales (fatigue, pain and nausea/vomiting \[N/V\]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss \[AL\] and financial difficulties \[FD\]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline (CFB) was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=10 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=8 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=8 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=10 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=3 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=10 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=10 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, Baseline (Day 1)
|
63.3 Score on scale
Standard Deviation 16.29
|
67.7 Score on scale
Standard Deviation 15.71
|
60.4 Score on scale
Standard Deviation 13.18
|
65.8 Score on scale
Standard Deviation 25.29
|
69.4 Score on scale
Standard Deviation 31.55
|
58.3 Score on scale
Standard Deviation 14.16
|
56.2 Score on scale
Standard Deviation 23.33
|
67.6 Score on scale
Standard Deviation 9.72
|
63.6 Score on scale
Standard Deviation 20.84
|
56.1 Score on scale
Standard Deviation 20.78
|
60.2 Score on scale
Standard Deviation 26.61
|
55.0 Score on scale
Standard Deviation 24.60
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to EoT
|
18.7 Score on scale
Standard Deviation 23.94
|
4.2 Score on scale
Standard Deviation 20.97
|
-16.7 Score on scale
Standard Deviation 18.00
|
-50.0 Score on scale
Standard Deviation 22.05
|
4.2 Score on scale
Standard Deviation 17.68
|
-4.2 Score on scale
Standard Deviation 14.43
|
-10.0 Score on scale
Standard Deviation 34.05
|
-8.3 Score on scale
Standard Deviation 11.79
|
0.0 Score on scale
Standard Deviation 13.94
|
-14.6 Score on scale
Standard Deviation 25.88
|
-4.2 Score on scale
Standard Deviation 17.68
|
-8.3 Score on scale
Standard Deviation 9.62
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, Baseline (Day 1)
|
82.0 Score on scale
Standard Deviation 10.91
|
89.4 Score on scale
Standard Deviation 11.48
|
73.3 Score on scale
Standard Deviation 21.97
|
67.3 Score on scale
Standard Deviation 23.82
|
88.9 Score on scale
Standard Deviation 13.88
|
78.7 Score on scale
Standard Deviation 15.65
|
75.0 Score on scale
Standard Deviation 15.60
|
84.4 Score on scale
Standard Deviation 17.95
|
85.5 Score on scale
Standard Deviation 17.34
|
70.9 Score on scale
Standard Deviation 25.69
|
66.7 Score on scale
Standard Deviation 31.27
|
78.7 Score on scale
Standard Deviation 19.58
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to EoT
|
-11.7 Score on scale
Standard Deviation 42.64
|
-1.7 Score on scale
Standard Deviation 12.62
|
0.0 Score on scale
Standard Deviation 33.11
|
-17.8 Score on scale
Standard Deviation 48.23
|
13.3 Score on scale
Standard Deviation 18.86
|
-6.7 Score on scale
Standard Deviation 24.94
|
-5.3 Score on scale
Standard Deviation 22.80
|
-10.0 Score on scale
Standard Deviation 14.14
|
-1.1 Score on scale
Standard Deviation 9.81
|
-12.5 Score on scale
Standard Deviation 27.93
|
3.3 Score on scale
Standard Deviation 4.71
|
-10.0 Score on scale
Standard Deviation 15.87
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, Baseline (Day 1)
|
71.7 Score on scale
Standard Deviation 22.29
|
89.6 Score on scale
Standard Deviation 19.80
|
72.9 Score on scale
Standard Deviation 29.46
|
66.7 Score on scale
Standard Deviation 30.43
|
88.9 Score on scale
Standard Deviation 19.25
|
76.7 Score on scale
Standard Deviation 22.50
|
68.1 Score on scale
Standard Deviation 21.86
|
72.2 Score on scale
Standard Deviation 22.05
|
81.8 Score on scale
Standard Deviation 24.10
|
57.6 Score on scale
Standard Deviation 36.03
|
70.4 Score on scale
Standard Deviation 33.10
|
73.3 Score on scale
Standard Deviation 19.56
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to EoT
|
20.8 Score on scale
Standard Deviation 36.96
|
-4.2 Score on scale
Standard Deviation 28.46
|
4.2 Score on scale
Standard Deviation 34.36
|
-22.2 Score on scale
Standard Deviation 69.39
|
16.7 Score on scale
Standard Deviation 23.57
|
8.3 Score on scale
Standard Deviation 34.69
|
-6.7 Score on scale
Standard Deviation 25.28
|
-8.3 Score on scale
Standard Deviation 35.36
|
-11.1 Score on scale
Standard Deviation 27.22
|
0.0 Score on scale
Standard Deviation 32.12
|
0.0 Score on scale
Standard Deviation 0.00
|
-20.8 Score on scale
Standard Deviation 34.36
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, Baseline (Day 1)
|
95.0 Score on scale
Standard Deviation 8.05
|
91.7 Score on scale
Standard Deviation 12.60
|
72.9 Score on scale
Standard Deviation 21.71
|
75.0 Score on scale
Standard Deviation 16.20
|
88.9 Score on scale
Standard Deviation 9.62
|
71.7 Score on scale
Standard Deviation 24.91
|
81.9 Score on scale
Standard Deviation 19.41
|
87.0 Score on scale
Standard Deviation 13.89
|
81.8 Score on scale
Standard Deviation 17.41
|
74.2 Score on scale
Standard Deviation 15.57
|
74.1 Score on scale
Standard Deviation 16.90
|
83.3 Score on scale
Standard Deviation 22.22
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to EoT
|
-16.7 Score on scale
Standard Deviation 27.22
|
-8.3 Score on scale
Standard Deviation 9.62
|
12.5 Score on scale
Standard Deviation 20.97
|
-16.7 Score on scale
Standard Deviation 44.10
|
8.3 Score on scale
Standard Deviation 11.79
|
16.7 Score on scale
Standard Deviation 19.25
|
-10.0 Score on scale
Standard Deviation 25.28
|
-16.7 Score on scale
Standard Deviation 23.57
|
2.8 Score on scale
Standard Deviation 6.80
|
0.0 Score on scale
Standard Deviation 17.82
|
8.3 Score on scale
Standard Deviation 11.79
|
-8.3 Score on scale
Standard Deviation 21.52
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, Baseline (Day 1)
|
73.3 Score on scale
Standard Deviation 17.92
|
75.0 Score on scale
Standard Deviation 23.57
|
77.1 Score on scale
Standard Deviation 21.71
|
71.7 Score on scale
Standard Deviation 26.12
|
88.9 Score on scale
Standard Deviation 19.25
|
80.0 Score on scale
Standard Deviation 18.92
|
76.4 Score on scale
Standard Deviation 20.67
|
83.3 Score on scale
Standard Deviation 18.63
|
77.3 Score on scale
Standard Deviation 28.16
|
71.2 Score on scale
Standard Deviation 28.95
|
72.2 Score on scale
Standard Deviation 34.36
|
68.3 Score on scale
Standard Deviation 34.65
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to EoT
|
-12.5 Score on scale
Standard Deviation 34.36
|
16.7 Score on scale
Standard Deviation 19.25
|
-12.5 Score on scale
Standard Deviation 36.96
|
-27.8 Score on scale
Standard Deviation 63.10
|
8.3 Score on scale
Standard Deviation 11.79
|
0.0 Score on scale
Standard Deviation 23.57
|
-6.7 Score on scale
Standard Deviation 25.28
|
-16.7 Score on scale
Standard Deviation 0.00
|
-11.1 Score on scale
Standard Deviation 22.77
|
-27.1 Score on scale
Standard Deviation 36.66
|
0.0 Score on scale
Standard Deviation 0.00
|
8.3 Score on scale
Standard Deviation 16.67
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, Baseline (Day 1)
|
37.8 Score on scale
Standard Deviation 25.77
|
31.9 Score on scale
Standard Deviation 3.93
|
38.9 Score on scale
Standard Deviation 19.70
|
46.7 Score on scale
Standard Deviation 23.89
|
25.9 Score on scale
Standard Deviation 16.97
|
31.1 Score on scale
Standard Deviation 8.76
|
34.3 Score on scale
Standard Deviation 19.22
|
28.4 Score on scale
Standard Deviation 21.60
|
29.3 Score on scale
Standard Deviation 13.40
|
34.3 Score on scale
Standard Deviation 26.51
|
30.9 Score on scale
Standard Deviation 30.32
|
32.2 Score on scale
Standard Deviation 23.10
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to EoT
|
-2.8 Score on scale
Standard Deviation 41.94
|
-11.1 Score on scale
Standard Deviation 12.83
|
2.8 Score on scale
Standard Deviation 24.64
|
3.7 Score on scale
Standard Deviation 35.72
|
-11.1 Score on scale
Standard Deviation 15.71
|
5.6 Score on scale
Standard Deviation 6.42
|
13.3 Score on scale
Standard Deviation 28.76
|
-11.1 Score on scale
Standard Deviation 15.71
|
-3.7 Score on scale
Standard Deviation 13.46
|
16.7 Score on scale
Standard Deviation 33.60
|
11.1 Score on scale
Standard Deviation 15.71
|
2.8 Score on scale
Standard Deviation 18.98
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to EoT
|
4.2 Score on scale
Standard Deviation 8.33
|
0.0 Score on scale
Standard Deviation 13.61
|
-4.2 Score on scale
Standard Deviation 8.33
|
11.1 Score on scale
Standard Deviation 41.94
|
0.0 Score on scale
Standard Deviation 0.00
|
4.2 Score on scale
Standard Deviation 8.33
|
-6.7 Score on scale
Standard Deviation 30.28
|
-8.3 Score on scale
Standard Deviation 11.79
|
5.6 Score on scale
Standard Deviation 17.21
|
6.3 Score on scale
Standard Deviation 12.40
|
0.0 Score on scale
Standard Deviation 0.00
|
-4.2 Score on scale
Standard Deviation 8.33
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, Baseline (Day 1)
|
36.7 Score on scale
Standard Deviation 25.82
|
22.9 Score on scale
Standard Deviation 21.71
|
37.5 Score on scale
Standard Deviation 31.81
|
46.7 Score on scale
Standard Deviation 35.83
|
22.2 Score on scale
Standard Deviation 25.46
|
36.7 Score on scale
Standard Deviation 24.60
|
41.7 Score on scale
Standard Deviation 26.11
|
24.1 Score on scale
Standard Deviation 29.00
|
28.8 Score on scale
Standard Deviation 25.92
|
34.8 Score on scale
Standard Deviation 34.52
|
42.6 Score on scale
Standard Deviation 33.45
|
28.3 Score on scale
Standard Deviation 20.86
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to EoT
|
-4.2 Score on scale
Standard Deviation 43.83
|
8.3 Score on scale
Standard Deviation 16.67
|
-25.0 Score on scale
Standard Deviation 50.00
|
0.0 Score on scale
Standard Deviation 16.67
|
-16.7 Score on scale
Standard Deviation 47.14
|
-12.5 Score on scale
Standard Deviation 15.96
|
20.0 Score on scale
Standard Deviation 36.13
|
-16.7 Score on scale
Standard Deviation 23.57
|
-5.6 Score on scale
Standard Deviation 8.61
|
12.5 Score on scale
Standard Deviation 30.54
|
-8.3 Score on scale
Standard Deviation 11.79
|
25.0 Score on scale
Standard Deviation 31.91
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnoea, Baseline (Day 1)
|
16.7 Score on scale
Standard Deviation 17.57
|
8.3 Score on scale
Standard Deviation 15.43
|
12.5 Score on scale
Standard Deviation 17.25
|
33.3 Score on scale
Standard Deviation 35.14
|
11.1 Score on scale
Standard Deviation 19.25
|
13.3 Score on scale
Standard Deviation 17.21
|
22.2 Score on scale
Standard Deviation 25.95
|
11.1 Score on scale
Standard Deviation 16.67
|
15.2 Score on scale
Standard Deviation 17.41
|
33.3 Score on scale
Standard Deviation 36.51
|
14.8 Score on scale
Standard Deviation 24.22
|
16.7 Score on scale
Standard Deviation 17.57
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnoea, CFB to EoT
|
16.7 Score on scale
Standard Deviation 19.25
|
0.0 Score on scale
Standard Deviation 0.00
|
16.7 Score on scale
Standard Deviation 19.25
|
33.3 Score on scale
Standard Deviation 33.33
|
-16.7 Score on scale
Standard Deviation 23.57
|
25.0 Score on scale
Standard Deviation 31.91
|
0.0 Score on scale
Standard Deviation 23.57
|
0.0 Score on scale
Standard Deviation 0.00
|
-5.6 Score on scale
Standard Deviation 13.61
|
12.5 Score on scale
Standard Deviation 39.59
|
16.7 Score on scale
Standard Deviation 23.57
|
0.0 Score on scale
Standard Deviation 0.00
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, Baseline (Day 1)
|
30.0 Score on scale
Standard Deviation 33.15
|
8.3 Score on scale
Standard Deviation 15.43
|
29.2 Score on scale
Standard Deviation 21.36
|
40.0 Score on scale
Standard Deviation 26.29
|
44.4 Score on scale
Standard Deviation 38.49
|
33.3 Score on scale
Standard Deviation 27.22
|
36.1 Score on scale
Standard Deviation 33.21
|
25.9 Score on scale
Standard Deviation 14.70
|
27.3 Score on scale
Standard Deviation 25.03
|
33.3 Score on scale
Standard Deviation 33.33
|
37.0 Score on scale
Standard Deviation 38.89
|
33.3 Score on scale
Standard Deviation 31.43
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to EoT
|
0.0 Score on scale
Standard Deviation 54.43
|
0.0 Score on scale
Standard Deviation 0.00
|
0.0 Score on scale
Standard Deviation 27.22
|
0.0 Score on scale
Standard Deviation 33.33
|
0.0 Score on scale
Standard Deviation 47.14
|
-16.7 Score on scale
Standard Deviation 19.25
|
-6.7 Score on scale
Standard Deviation 27.89
|
-16.7 Score on scale
Standard Deviation 23.57
|
5.6 Score on scale
Standard Deviation 25.09
|
8.3 Score on scale
Standard Deviation 23.57
|
0.0 Score on scale
Standard Deviation 47.14
|
-16.7 Score on scale
Standard Deviation 19.25
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, Baseline (Day 1)
|
6.7 Score on scale
Standard Deviation 14.05
|
12.5 Score on scale
Standard Deviation 24.80
|
25.0 Score on scale
Standard Deviation 23.57
|
23.3 Score on scale
Standard Deviation 27.44
|
0.0 Score on scale
Standard Deviation 0.00
|
6.7 Score on scale
Standard Deviation 14.05
|
13.9 Score on scale
Standard Deviation 22.29
|
7.4 Score on scale
Standard Deviation 14.70
|
12.1 Score on scale
Standard Deviation 16.82
|
9.1 Score on scale
Standard Deviation 15.57
|
22.2 Score on scale
Standard Deviation 23.57
|
26.7 Score on scale
Standard Deviation 26.29
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to EoT
|
25.0 Score on scale
Standard Deviation 50.00
|
-8.3 Score on scale
Standard Deviation 16.67
|
-16.7 Score on scale
Standard Deviation 19.25
|
22.2 Score on scale
Standard Deviation 19.25
|
16.7 Score on scale
Standard Deviation 23.57
|
16.7 Score on scale
Standard Deviation 19.25
|
0.0 Score on scale
Standard Deviation 33.33
|
16.7 Score on scale
Standard Deviation 23.57
|
0.0 Score on scale
Standard Deviation 0.00
|
-4.2 Score on scale
Standard Deviation 21.36
|
0.0 Score on scale
Standard Deviation 0.00
|
-8.3 Score on scale
Standard Deviation 41.94
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, Baseline (Day 1)
|
20.0 Score on scale
Standard Deviation 32.20
|
8.3 Score on scale
Standard Deviation 15.43
|
12.5 Score on scale
Standard Deviation 17.25
|
20.0 Score on scale
Standard Deviation 28.11
|
0.0 Score on scale
Standard Deviation 0.00
|
6.7 Score on scale
Standard Deviation 14.05
|
16.7 Score on scale
Standard Deviation 26.59
|
11.1 Score on scale
Standard Deviation 16.67
|
12.1 Score on scale
Standard Deviation 16.82
|
9.1 Score on scale
Standard Deviation 15.57
|
7.4 Score on scale
Standard Deviation 22.22
|
13.3 Score on scale
Standard Deviation 17.21
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to EoT
|
-25.0 Score on scale
Standard Deviation 31.91
|
16.7 Score on scale
Standard Deviation 19.25
|
16.7 Score on scale
Standard Deviation 33.33
|
0.0 Score on scale
Standard Deviation 0.00
|
16.7 Score on scale
Standard Deviation 23.57
|
16.7 Score on scale
Standard Deviation 33.33
|
0.0 Score on scale
Standard Deviation 0.00
|
0.0 Score on scale
Standard Deviation 47.14
|
0.0 Score on scale
Standard Deviation 0.00
|
4.2 Score on scale
Standard Deviation 21.36
|
0.0 Score on scale
Standard Deviation 0.00
|
0.0 Score on scale
Standard Deviation 0.00
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhoea, Baseline (Day 1)
|
6.7 Score on scale
Standard Deviation 14.05
|
12.5 Score on scale
Standard Deviation 17.25
|
8.3 Score on scale
Standard Deviation 15.43
|
6.7 Score on scale
Standard Deviation 14.05
|
0.0 Score on scale
Standard Deviation 0.00
|
16.7 Score on scale
Standard Deviation 23.57
|
19.4 Score on scale
Standard Deviation 22.29
|
11.1 Score on scale
Standard Deviation 16.67
|
9.1 Score on scale
Standard Deviation 15.57
|
21.2 Score on scale
Standard Deviation 34.23
|
11.1 Score on scale
Standard Deviation 33.33
|
6.7 Score on scale
Standard Deviation 21.08
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhoea, CFB to EoT
|
16.7 Score on scale
Standard Deviation 19.25
|
-8.3 Score on scale
Standard Deviation 31.91
|
8.3 Score on scale
Standard Deviation 16.67
|
22.2 Score on scale
Standard Deviation 19.25
|
33.3 Score on scale
Standard Deviation 47.14
|
8.3 Score on scale
Standard Deviation 31.91
|
-13.3 Score on scale
Standard Deviation 29.81
|
-16.7 Score on scale
Standard Deviation 23.57
|
-5.6 Score on scale
Standard Deviation 13.61
|
0.0 Score on scale
Standard Deviation 30.86
|
0.0 Score on scale
Standard Deviation 0.00
|
0.0 Score on scale
Standard Deviation 27.22
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, Baseline (Day 1)
|
20.0 Score on scale
Standard Deviation 35.83
|
20.8 Score on scale
Standard Deviation 35.36
|
0.0 Score on scale
Standard Deviation 0.00
|
30.0 Score on scale
Standard Deviation 33.15
|
11.1 Score on scale
Standard Deviation 19.25
|
30.0 Score on scale
Standard Deviation 36.68
|
36.1 Score on scale
Standard Deviation 30.01
|
7.4 Score on scale
Standard Deviation 14.70
|
24.2 Score on scale
Standard Deviation 36.79
|
15.2 Score on scale
Standard Deviation 17.41
|
25.9 Score on scale
Standard Deviation 27.78
|
26.7 Score on scale
Standard Deviation 37.84
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, Baseline (Day 1)
|
83.3 Score on scale
Standard Deviation 16.20
|
91.7 Score on scale
Standard Deviation 8.91
|
76.0 Score on scale
Standard Deviation 16.93
|
76.7 Score on scale
Standard Deviation 25.40
|
86.1 Score on scale
Standard Deviation 4.81
|
77.5 Score on scale
Standard Deviation 18.02
|
70.8 Score on scale
Standard Deviation 20.87
|
94.4 Score on scale
Standard Deviation 7.22
|
73.5 Score on scale
Standard Deviation 25.50
|
68.9 Score on scale
Standard Deviation 28.89
|
83.3 Score on scale
Standard Deviation 13.18
|
78.3 Score on scale
Standard Deviation 17.21
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to EoT
|
-12.5 Score on scale
Standard Deviation 15.96
|
6.3 Score on scale
Standard Deviation 12.50
|
10.4 Score on scale
Standard Deviation 15.77
|
5.6 Score on scale
Standard Deviation 29.27
|
-12.5 Score on scale
Standard Deviation 5.89
|
0.0 Score on scale
Standard Deviation 0.00
|
3.3 Score on scale
Standard Deviation 33.64
|
-16.7 Score on scale
Standard Deviation 23.57
|
0.0 Score on scale
Standard Deviation 11.79
|
-6.3 Score on scale
Standard Deviation 25.49
|
-12.5 Score on scale
Standard Deviation 5.89
|
2.1 Score on scale
Standard Deviation 14.23
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, Baseline (Day 1)
|
5.0 Score on scale
Standard Deviation 8.05
|
2.1 Score on scale
Standard Deviation 5.89
|
2.1 Score on scale
Standard Deviation 5.89
|
11.7 Score on scale
Standard Deviation 15.81
|
0.0 Score on scale
Standard Deviation 0.00
|
11.7 Score on scale
Standard Deviation 15.81
|
8.3 Score on scale
Standard Deviation 15.08
|
3.7 Score on scale
Standard Deviation 7.35
|
4.5 Score on scale
Standard Deviation 7.78
|
1.5 Score on scale
Standard Deviation 5.03
|
5.6 Score on scale
Standard Deviation 8.33
|
8.3 Score on scale
Standard Deviation 11.79
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to EoT
|
8.3 Score on scale
Standard Deviation 16.67
|
-16.7 Score on scale
Standard Deviation 33.33
|
0.0 Score on scale
Standard Deviation 0.00
|
33.3 Score on scale
Standard Deviation 57.74
|
0.0 Score on scale
Standard Deviation 0.00
|
8.3 Score on scale
Standard Deviation 31.91
|
-13.3 Score on scale
Standard Deviation 18.26
|
0.0 Score on scale
Standard Deviation 0.00
|
0.0 Score on scale
Standard Deviation 0.00
|
4.2 Score on scale
Standard Deviation 21.36
|
0.0 Score on scale
Standard Deviation 0.00
|
16.7 Score on scale
Standard Deviation 19.25
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to approximately 4.5 years (End of treatment [EoT])Population: All Treated. Only those participants with data available at specified time points have been analyzed.
The EORTC QLQ-MY20 is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. The module comprised of 20 questions that addressed four myeloma-specific HRQoL domains: disease symptoms (DS), side effects of treatment (SET), future perspective (FP) and body image (BI). Responses are 1 to 4. Scores were averaged and scales were transformed to 0 to 100 scale. A high score for disease symptoms and side effects of treatment represented a high level of symptomatology or problems, whereas a high score for future perspective and body image represented better outcomes. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=10 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=8 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=10 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=3 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=10 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 Participants
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=11 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=9 Participants
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=10 Participants
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score
SET, CFB to EoT
|
5.6 Score on scale
Standard Deviation 8.74
|
6.5 Score on scale
Standard Deviation 20.14
|
0.0 Score on scale
Standard Deviation 9.07
|
-11.4 Score on scale
Standard Deviation 15.19
|
-14.8 Score on scale
Standard Deviation 15.71
|
0.1 Score on scale
Standard Deviation 7.86
|
0.0 Score on scale
Standard Deviation 14.60
|
1.9 Score on scale
Standard Deviation 7.86
|
3.3 Score on scale
Standard Deviation 5.00
|
19.0 Score on scale
Standard Deviation 19.38
|
1.1 Score on scale
Standard Deviation 6.81
|
-2.7 Score on scale
Standard Deviation 8.74
|
|
Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score
FP, Baseline (Day 1)
|
63.3 Score on scale
Standard Deviation 16.60
|
66.7 Score on scale
Standard Deviation 13.28
|
72.8 Score on scale
Standard Deviation 16.77
|
58.9 Score on scale
Standard Deviation 29.65
|
48.1 Score on scale
Standard Deviation 12.83
|
58.9 Score on scale
Standard Deviation 28.71
|
65.7 Score on scale
Standard Deviation 17.38
|
67.9 Score on scale
Standard Deviation 17.07
|
55.6 Score on scale
Standard Deviation 31.03
|
59.3 Score on scale
Standard Deviation 23.57
|
58.0 Score on scale
Standard Deviation 34.15
|
62.2 Score on scale
Standard Deviation 15.00
|
|
Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score
FP, CFB to EoT
|
-2.8 Score on scale
Standard Deviation 44.79
|
22.2 Score on scale
Standard Deviation 15.71
|
13.9 Score on scale
Standard Deviation 13.98
|
-7.4 Score on scale
Standard Deviation 51.32
|
38.9 Score on scale
Standard Deviation 39.28
|
16.7 Score on scale
Standard Deviation 19.25
|
-6.7 Score on scale
Standard Deviation 21.66
|
0.0 Score on scale
Standard Deviation 15.71
|
1.9 Score on scale
Standard Deviation 14.77
|
-3.2 Score on scale
Standard Deviation 22.87
|
-5.6 Score on scale
Standard Deviation 7.86
|
-8.3 Score on scale
Standard Deviation 31.91
|
|
Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score
DS, Baseline (Day 1)
|
25.6 Score on scale
Standard Deviation 20.15
|
18.8 Score on scale
Standard Deviation 8.88
|
24.7 Score on scale
Standard Deviation 19.47
|
45.0 Score on scale
Standard Deviation 25.45
|
24.1 Score on scale
Standard Deviation 22.45
|
26.6 Score on scale
Standard Deviation 12.22
|
40.7 Score on scale
Standard Deviation 19.58
|
21.0 Score on scale
Standard Deviation 19.40
|
21.2 Score on scale
Standard Deviation 17.88
|
31.5 Score on scale
Standard Deviation 21.15
|
29.0 Score on scale
Standard Deviation 23.37
|
26.7 Score on scale
Standard Deviation 15.89
|
|
Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score
DS, CFB to EoT
|
12.5 Score on scale
Standard Deviation 20.48
|
4.2 Score on scale
Standard Deviation 13.13
|
-5.6 Score on scale
Standard Deviation 36.00
|
-14.8 Score on scale
Standard Deviation 17.86
|
-8.3 Score on scale
Standard Deviation 27.50
|
10.0 Score on scale
Standard Deviation 9.34
|
23.3 Score on scale
Standard Deviation 26.76
|
-2.8 Score on scale
Standard Deviation 19.64
|
-8.3 Score on scale
Standard Deviation 10.39
|
5.6 Score on scale
Standard Deviation 22.22
|
5.6 Score on scale
Standard Deviation 15.71
|
-2.8 Score on scale
Standard Deviation 18.43
|
|
Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score
SET, Baseline (Day 1)
|
13.9 Score on scale
Standard Deviation 13.60
|
11.3 Score on scale
Standard Deviation 8.99
|
18.8 Score on scale
Standard Deviation 13.87
|
27.5 Score on scale
Standard Deviation 16.65
|
21.0 Score on scale
Standard Deviation 18.64
|
19.9 Score on scale
Standard Deviation 11.20
|
23.6 Score on scale
Standard Deviation 13.79
|
7.7 Score on scale
Standard Deviation 6.87
|
12.7 Score on scale
Standard Deviation 9.65
|
15.1 Score on scale
Standard Deviation 9.43
|
14.9 Score on scale
Standard Deviation 6.21
|
16.7 Score on scale
Standard Deviation 14.21
|
|
Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score
BI, Baseline (Day 1)
|
93.3 Score on scale
Standard Deviation 14.05
|
75.0 Score on scale
Standard Deviation 34.50
|
81.5 Score on scale
Standard Deviation 24.22
|
83.3 Score on scale
Standard Deviation 17.57
|
100.0 Score on scale
Standard Deviation 0.00
|
76.7 Score on scale
Standard Deviation 31.62
|
77.8 Score on scale
Standard Deviation 29.59
|
85.2 Score on scale
Standard Deviation 24.22
|
69.7 Score on scale
Standard Deviation 37.87
|
88.9 Score on scale
Standard Deviation 16.67
|
77.8 Score on scale
Standard Deviation 33.33
|
90.0 Score on scale
Standard Deviation 22.50
|
|
Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score
BI, CFB to EoT
|
-8.3 Score on scale
Standard Deviation 16.67
|
16.7 Score on scale
Standard Deviation 19.25
|
8.3 Score on scale
Standard Deviation 41.94
|
-11.1 Score on scale
Standard Deviation 50.92
|
-16.7 Score on scale
Standard Deviation 23.57
|
-8.3 Score on scale
Standard Deviation 31.91
|
6.7 Score on scale
Standard Deviation 14.91
|
0.0 Score on scale
Standard Deviation 0.00
|
0.0 Score on scale
Standard Deviation 0.00
|
-9.5 Score on scale
Standard Deviation 16.27
|
0.0 Score on scale
Standard Deviation 0.00
|
-8.3 Score on scale
Standard Deviation 16.67
|
Adverse Events
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
Serious events: 6 serious events
Other events: 12 other events
Deaths: 3 deaths
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Serious events: 6 serious events
Other events: 13 other events
Deaths: 6 deaths
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
Serious events: 10 serious events
Other events: 16 other events
Deaths: 8 deaths
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Serious events: 8 serious events
Other events: 12 other events
Deaths: 4 deaths
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Serious events: 8 serious events
Other events: 12 other events
Deaths: 2 deaths
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Serious events: 6 serious events
Other events: 12 other events
Deaths: 4 deaths
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Serious events: 6 serious events
Other events: 12 other events
Deaths: 5 deaths
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Serious events: 7 serious events
Other events: 13 other events
Deaths: 5 deaths
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Serious events: 13 serious events
Other events: 18 other events
Deaths: 8 deaths
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Serious events: 6 serious events
Other events: 12 other events
Deaths: 6 deaths
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Serious events: 9 serious events
Other events: 16 other events
Deaths: 4 deaths
PACT Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
PACT Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PACT Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PACT Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
PACT Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
PACT Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
PACT Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
PACT Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PACT Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PACT Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 participants at risk
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 participants at risk
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 participants at risk
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=16 participants at risk
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 participants at risk
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 participants at risk
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 participants at risk
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=12 participants at risk
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=13 participants at risk
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=18 participants at risk
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=12 participants at risk
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=16 participants at risk
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
PACT Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=3 participants at risk
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=1 participants at risk
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=2 participants at risk
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=4 participants at risk
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=2 participants at risk
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 1.9 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=4 participants at risk
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 1.9 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=4 participants at risk
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 2.5 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=2 participants at risk
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 2.5 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=2 participants at risk
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 2.5 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=1 participants at risk
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 3.4 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
COVID-19
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
50.0%
1/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Campylobacter colitis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Meningitis cryptococcal
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pseudomonas infection
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Septic shock
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
2/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
50.0%
1/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Autonomic neuropathy
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Cytopenia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Malaise
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Haematoma
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Cataract
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatic Vein Occlusion
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Abscess
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Nodular regenerative hyperplasia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=12 participants at risk
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=4 participants at risk
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=13 participants at risk
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=16 participants at risk
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=12 participants at risk
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=12 participants at risk
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=12 participants at risk
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
n=12 participants at risk
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=13 participants at risk
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=18 participants at risk
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=12 participants at risk
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
n=16 participants at risk
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
|
PACT Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
n=3 participants at risk
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
n=1 participants at risk
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
n=2 participants at risk
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
n=4 participants at risk
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
n=2 participants at risk
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 1.9 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
n=4 participants at risk
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 1.9 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
n=4 participants at risk
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 2.5 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
n=2 participants at risk
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 2.5 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
n=2 participants at risk
Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 2.5 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
PACT Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
n=1 participants at risk
Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles followed by belantamab mafodotin monotherapy as 3.4 mg/kg dose until PD, death, intolerable toxicity, or consent withdrawn.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Ocular discomfort
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Periorbital swelling
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Photophobia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
30.8%
4/13 • Number of events 9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
33.3%
6/18 • Number of events 12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Pterygium
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
3/18 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Uveitis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
53.8%
7/13 • Number of events 12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
37.5%
6/16 • Number of events 27 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
41.7%
5/12 • Number of events 10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
41.7%
5/12 • Number of events 9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
38.5%
5/13 • Number of events 17 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
66.7%
12/18 • Number of events 56 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
43.8%
7/16 • Number of events 24 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Visual acuity reduced
|
41.7%
5/12 • Number of events 26 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 23 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
30.8%
4/13 • Number of events 29 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
31.2%
5/16 • Number of events 77 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
33.3%
4/12 • Number of events 26 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
50.0%
6/12 • Number of events 39 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
33.3%
4/12 • Number of events 49 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
33.3%
4/12 • Number of events 24 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 39 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Visual impairment
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
50.0%
2/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Aerophagia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
50.0%
2/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
23.1%
3/13 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
66.7%
8/12 • Number of events 8 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
41.7%
5/12 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
33.3%
6/18 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
43.8%
7/16 • Number of events 8 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
41.7%
5/12 • Number of events 9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
75.0%
3/4 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
46.2%
6/13 • Number of events 9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
37.5%
6/16 • Number of events 11 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
50.0%
6/12 • Number of events 13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
41.7%
5/12 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
50.0%
6/12 • Number of events 11 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
30.8%
4/13 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
44.4%
8/18 • Number of events 12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
4/16 • Number of events 9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
30.8%
4/13 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
31.2%
5/16 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
23.1%
3/13 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
22.2%
4/18 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
50.0%
2/4 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
23.1%
3/13 • Number of events 18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Oedema
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 8 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
43.8%
7/16 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
33.3%
4/12 • Number of events 8 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
41.7%
5/12 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
41.7%
5/12 • Number of events 9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
69.2%
9/13 • Number of events 13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
33.3%
6/18 • Number of events 18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
75.0%
9/12 • Number of events 10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
56.2%
9/16 • Number of events 12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac failure
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Mitral valve incompetence
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Congenital, familial and genetic disorders
Muir-Torre syndrome
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Age-related macular degeneration
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Asthenopia
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Blepharitis
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 8 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Blepharospasm
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Blindness
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Cataract
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Cataract cortical
|
8.3%
1/12 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Cataract nuclear
|
16.7%
2/12 • Number of events 8 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Chalazion
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Cornea verticillata
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Corneal epithelium defect
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Corneal oedema
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Corneal opacity
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Diplopia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Dry eye
|
8.3%
1/12 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
22.2%
4/18 • Number of events 9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
4/16 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Eye irritation
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Eye pain
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
23.1%
3/13 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
22.2%
4/18 • Number of events 10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Foreign body sensation in eyes
|
16.7%
2/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Glaucoma
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Keratitis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Keratopathy
|
75.0%
9/12 • Number of events 114 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
75.0%
3/4 • Number of events 52 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
92.3%
12/13 • Number of events 122 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
68.8%
11/16 • Number of events 224 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
75.0%
9/12 • Number of events 61 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
91.7%
11/12 • Number of events 111 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
100.0%
12/12 • Number of events 123 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
100.0%
12/12 • Number of events 85 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
76.9%
10/13 • Number of events 97 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
83.3%
15/18 • Number of events 188 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
83.3%
10/12 • Number of events 130 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
93.8%
15/16 • Number of events 143 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Meibomian gland dysfunction
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Eye disorders
Night blindness
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
3/18 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Hyperaesthesia teeth
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Loose tooth
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
50.0%
2/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
30.8%
4/13 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
33.3%
4/12 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
41.7%
5/12 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
23.1%
3/13 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
44.4%
8/18 • Number of events 18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
43.8%
7/16 • Number of events 10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
3/18 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
31.2%
5/16 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Asthenia
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Catheter site bruise
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Catheter site pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Chest pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Chills
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Crepitations
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Disease progression
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Face oedema
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Facial pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
30.8%
4/13 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
43.8%
7/16 • Number of events 10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
41.7%
5/12 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
33.3%
4/12 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
41.7%
5/12 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
30.8%
4/13 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
33.3%
6/18 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
41.7%
5/12 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Feeling abnormal
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Gait disturbance
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Injection site bruising
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Injection site erythema
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Injection site reaction
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Localised oedema
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Malaise
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Oedema peripheral
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
33.3%
4/12 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
41.7%
5/12 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
3/18 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
31.2%
5/16 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Peripheral swelling
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Soft tissue inflammation
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
General disorders
Swelling
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Abscess
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
COVID-19
|
25.0%
3/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
33.3%
4/12 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Campylobacter colitis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Candida infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cystitis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Ear infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Eye infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Herpes ophthalmic
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Lip infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nail infection
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nosocomial infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Oral candidiasis
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Picornavirus infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Prostate infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
50.0%
9/18 • Number of events 11 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
37.5%
6/16 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
4/12 • Number of events 8 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection viral
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Viral infection
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Chemical burns of eye
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
22.2%
4/18 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
4/16 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
41.7%
5/12 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
33.3%
4/12 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Blood uric acid decreased
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
50.0%
6/12 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Grip strength decreased
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Lipids increased
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
41.7%
5/12 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Neutrophil count decreased
|
33.3%
4/12 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
30.8%
4/13 • Number of events 9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
31.2%
5/16 • Number of events 14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 17 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Occult blood positive
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Platelet count decreased
|
25.0%
3/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
38.5%
5/13 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
4/16 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
50.0%
6/12 • Number of events 13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
75.0%
9/12 • Number of events 12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
58.3%
7/12 • Number of events 12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
58.3%
7/12 • Number of events 12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
50.0%
9/18 • Number of events 11 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
31.2%
5/16 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Troponin T increased
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Urine albumin/creatinine ratio increased
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Urine output decreased
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Visual acuity tests abnormal
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 25 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Weight decreased
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
Weight increased
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
3/18 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Appetite disorder
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
27.8%
5/18 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
4/16 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
3/18 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
4/16 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
4/16 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Magnesium deficiency
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Steroid diabetes
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
23.1%
3/13 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
30.8%
4/13 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
3/18 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
23.1%
3/13 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
23.1%
3/13 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
27.8%
5/18 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone cyst
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
23.1%
3/13 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest wall haematoma
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Diffuse idiopathic skeletal hyperostosis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Exposed bone in jaw
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
4/16 • Number of events 8 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
23.1%
3/13 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spondyloarthropathy
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Autonomic neuropathy
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Balance disorder
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
33.3%
4/12 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
31.2%
5/16 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
33.3%
4/12 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Lethargy
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Migraine
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
23.1%
3/13 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
33.3%
6/18 • Number of events 8 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
50.0%
8/16 • Number of events 10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
33.3%
4/12 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
22.2%
4/18 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
4/16 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Restless legs syndrome
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Tremor
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Delirium
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
41.7%
5/12 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
50.0%
2/4 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
37.5%
6/16 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
50.0%
6/12 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
33.3%
4/12 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
23.1%
3/13 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
33.3%
6/18 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
4/16 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Persistent depressive disorder
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Genital lesion
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
3/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
30.8%
4/13 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
3/18 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
4/16 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
33.3%
4/12 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
23.1%
3/13 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
3/18 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
3/18 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Blister
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Cold urticaria
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
2/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
3/12 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Flushing
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Haematoma
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hot flush
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
22.2%
4/18 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
All treated population included all participants who received at least one dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER