NCT03544281 · ADVERSE EVENTS

Adverse events

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) · Source last updated 2025-03-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.
Other-event reporting threshold: 5%

All treated population included all participants who received at least one dose of study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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.	6 / 12	12 / 12	3 / 12
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.	2 / 4	4 / 4	2 / 4
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.	6 / 13	13 / 13	6 / 13
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.	10 / 16	16 / 16	8 / 16
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.	8 / 12	12 / 12	4 / 12
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.	8 / 12	12 / 12	2 / 12
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.	6 / 12	12 / 12	4 / 12
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.	6 / 12	12 / 12	5 / 12
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.	7 / 13	13 / 13	5 / 13
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.	13 / 18	18 / 18	8 / 18
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.	6 / 12	12 / 12	6 / 12
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.	9 / 16	16 / 16	4 / 16
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.	1 / 3	0 / 3	0 / 3
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.	0 / 1	0 / 1	0 / 1
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.	0 / 2	0 / 2	0 / 2
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.	2 / 4	0 / 4	0 / 4
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.	1 / 2	0 / 2	0 / 2
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.	1 / 4	0 / 4	0 / 4
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.	1 / 4	0 / 4	0 / 4
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.	0 / 2	0 / 2	0 / 2
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.	0 / 2	0 / 2	0 / 2
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.	0 / 1	0 / 1	0 / 1

Group identifiers: EG000: Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex · EG001: Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex · EG002: Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex · EG003: Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex · EG004: Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex · EG005: Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex · EG006: Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex · EG007: Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex · EG008: Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex · EG009: Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex · EG010: Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex · EG011: Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex · EG012: PACT Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex · EG013: PACT Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex · EG014: PACT Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex · EG015: PACT Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex · EG016: PACT Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex · EG017: PACT Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex · EG018: PACT Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex · EG019: PACT Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex · EG020: PACT Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex · EG021: PACT Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
2
num At Risk
12
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
13
num Events
5
group Id
EG003
num Affected
3
num At Risk
16
num Events
5
group Id
EG004
num Affected
3
num At Risk
12
num Events
3
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
1
num At Risk
13
num Events
1
group Id
EG009
num Affected
2
num At Risk
18
num Events
5
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
1
num At Risk
16
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
13
num Events
1
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
1
num At Risk
12
num Events
1
group Id
EG007
num Affected
1
num At Risk
12
num Events
1
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
COVID-19 pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
13
num Events
1
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
2
num At Risk
12
num Events
2
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
2
num At Risk
18
num Events
4
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
1
num At Risk
16
num Events
1
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
1
num At Risk
12
num Events
1
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
13
num Events
1
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
12
num Events
1
group Id
EG006
num Affected
1
num At Risk
12
num Events
1
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Campylobacter colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
13
num Events
1
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Campylobacter gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
1
num At Risk
12
num Events
1
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
1
num At Risk
18
num Events
1
group Id
EG010
num Affected
1
num At Risk
12
num Events
1
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
13
num Events
1
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Gastroenteritis norovirus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Meningitis cryptococcal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Parainfluenzae virus infection

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
2
num At Risk
12
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
4
num At Risk
13
num Events
5
group Id
EG003
num Affected
5
num At Risk
16
num Events
5
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
3
num At Risk
12
num Events
6
group Id
EG006
num Affected
2
num At Risk
12
num Events
2
group Id
EG007
num Affected
3
num At Risk
12
num Events
3
group Id
EG008
num Affected
3
num At Risk
13
num Events
3
group Id
EG009
num Affected
4
num At Risk
18
num Events
5
group Id
EG010
num Affected
2
num At Risk
12
num Events
2
group Id
EG011
num Affected
2
num At Risk
16
num Events
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
12
num Events
1
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
1
num At Risk
12
num Events
1
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
1
num At Risk
12
num Events
1
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
1
num At Risk
18
num Events
1
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
13
num Events
1
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
12
num Events
2
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
2
num At Risk
4
num Events
3
group Id
EG002
num Affected
3
num At Risk
13
num Events
18
group Id
EG003
num Affected
2
num At Risk
16
num Events
3
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
2
num At Risk
12
num Events
7
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
2
num At Risk
13
num Events
3
group Id
EG009
num Affected
2
num At Risk
18
num Events
10
group Id
EG010
num Affected
2
num At Risk
12
num Events
2
group Id
EG011
num Affected
1
num At Risk
16
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
12
num Events
1
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Neutrophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
2
num At Risk
13
num Events
8
group Id
EG003
num Affected
7
num At Risk
16
num Events
7
group Id
EG004
num Affected
4
num At Risk
12
num Events
8
group Id
EG005
num Affected
5
num At Risk
12
num Events
6
group Id
EG006
num Affected
3
num At Risk
12
num Events
10
group Id
EG007
num Affected
5
num At Risk
12
num Events
9
group Id
EG008
num Affected
9
num At Risk
13
num Events
13
group Id
EG009
num Affected
6
num At Risk
18
num Events
18
group Id
EG010
num Affected
9
num At Risk
12
num Events
10
group Id
EG011
num Affected
9
num At Risk
16
num Events
12
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Aortic valve disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
2
num At Risk
13
num Events
2
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
2
num At Risk
12
num Events
2
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
1
num At Risk
12
num Events
1
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
13
num Events
1
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
12
num Events
1
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
1
num At Risk
12
num Events
1
group Id
EG011
num Affected
1
num At Risk
16
num Events
1
term
Atrioventricular block first degree

Complete source fields

description

All treated population included all participants who received at least one dose of study treatment.

event Groups

deaths Num Affected
3
deaths Num At Risk
12
description
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.
id
EG000
other Num Affected
12
other Num At Risk
12
serious Num Affected
6
serious Num At Risk
12
title
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
deaths Num Affected
2
deaths Num At Risk
4
description
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.
id
EG001
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
deaths Num Affected
6
deaths Num At Risk
13
description
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.
id
EG002
other Num Affected
13
other Num At Risk
13
serious Num Affected
6
serious Num At Risk
13
title
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
deaths Num Affected
8
deaths Num At Risk
16
description
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.
id
EG003
other Num Affected
16
other Num At Risk
16
serious Num Affected
10
serious Num At Risk
16
title
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
deaths Num Affected
4
deaths Num At Risk
12
description
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.
id
EG004
other Num Affected
12
other Num At Risk
12
serious Num Affected
8
serious Num At Risk
12
title
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
deaths Num Affected
2
deaths Num At Risk
12
description
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.
id
EG005
other Num Affected
12
other Num At Risk
12
serious Num Affected
8
serious Num At Risk
12
title
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
deaths Num Affected
4
deaths Num At Risk
12
description
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.
id
EG006
other Num Affected
12
other Num At Risk
12
serious Num Affected
6
serious Num At Risk
12
title
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
deaths Num Affected
5
deaths Num At Risk
12
description
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.
id
EG007
other Num Affected
12
other Num At Risk
12
serious Num Affected
6
serious Num At Risk
12
title
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
deaths Num Affected
5
deaths Num At Risk
13
description
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.
id
EG008
other Num Affected
13
other Num At Risk
13
serious Num Affected
7
serious Num At Risk
13
title
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
deaths Num Affected
8
deaths Num At Risk
18
description
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.
id
EG009
other Num Affected
18
other Num At Risk
18
serious Num Affected
13
serious Num At Risk
18
title
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
deaths Num Affected
6
deaths Num At Risk
12
description
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.
id
EG010
other Num Affected
12
other Num At Risk
12
serious Num Affected
6
serious Num At Risk
12
title
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
deaths Num Affected
4
deaths Num At Risk
16
description
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.
id
EG011
other Num Affected
16
other Num At Risk
16
serious Num Affected
9
serious Num At Risk
16
title
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
2
num At Risk
12
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
4
num At Risk
13
num Events
5
group Id
EG003
num Affected
5
num At Risk
16
num Events
5
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
3
num At Risk
12
num Events
6
group Id
EG006
num Affected
2
num At Risk
12
num Events
2
group Id
EG007
num Affected
3
num At Risk
12
num Events
3
group Id
EG008
num Affected
3
num At Risk
13
num Events
3
group Id
EG009
num Affected
4
num At Risk
18
num Events
5
group Id
EG010
num Affected
2
num At Risk
12
num Events
2
group Id
EG011
num Affected
2
num At Risk
16
num Events
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
12
num Events
1
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
1
num At Risk
12
num Events
1
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
1
num At Risk
12
num Events
1
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
1
num At Risk
18
num Events
1
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
13
num Events
1
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
12
num Events
2
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
2
num At Risk
4
num Events
3
group Id
EG002
num Affected
3
num At Risk
13
num Events
18
group Id
EG003
num Affected
2
num At Risk
16
num Events
3
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
2
num At Risk
12
num Events
7
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
2
num At Risk
13
num Events
3
group Id
EG009
num Affected
2
num At Risk
18
num Events
10
group Id
EG010
num Affected
2
num At Risk
12
num Events
2
group Id
EG011
num Affected
1
num At Risk
16
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
12
num Events
1
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Neutrophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
2
num At Risk
13
num Events
8
group Id
EG003
num Affected
7
num At Risk
16
num Events
7
group Id
EG004
num Affected
4
num At Risk
12
num Events
8
group Id
EG005
num Affected
5
num At Risk
12
num Events
6
group Id
EG006
num Affected
3
num At Risk
12
num Events
10
group Id
EG007
num Affected
5
num At Risk
12
num Events
9
group Id
EG008
num Affected
9
num At Risk
13
num Events
13
group Id
EG009
num Affected
6
num At Risk
18
num Events
18
group Id
EG010
num Affected
9
num At Risk
12
num Events
10
group Id
EG011
num Affected
9
num At Risk
16
num Events
12
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Aortic valve disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
2
num At Risk
13
num Events
2
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
2
num At Risk
12
num Events
2
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
1
num At Risk
12
num Events
1
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
13
num Events
1
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
12
num Events
1
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v 25.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
1
num At Risk
12
num Events
1
group Id
EG011
num Affected
1
num At Risk
16
num Events
1
term
Atrioventricular block first degree

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
2
num At Risk
12
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
13
num Events
5
group Id
EG003
num Affected
3
num At Risk
16
num Events
5
group Id
EG004
num Affected
3
num At Risk
12
num Events
3
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
1
num At Risk
13
num Events
1
group Id
EG009
num Affected
2
num At Risk
18
num Events
5
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
1
num At Risk
16
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
13
num Events
1
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
1
num At Risk
12
num Events
1
group Id
EG007
num Affected
1
num At Risk
12
num Events
1
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
COVID-19 pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
13
num Events
1
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
2
num At Risk
12
num Events
2
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
2
num At Risk
18
num Events
4
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
1
num At Risk
16
num Events
1
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
1
num At Risk
12
num Events
1
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
13
num Events
1
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
12
num Events
1
group Id
EG006
num Affected
1
num At Risk
12
num Events
1
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Campylobacter colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
13
num Events
1
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Campylobacter gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
1
num At Risk
12
num Events
1
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
1
num At Risk
18
num Events
1
group Id
EG010
num Affected
1
num At Risk
12
num Events
1
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
13
num Events
1
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Gastroenteritis norovirus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Meningitis cryptococcal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v 27.1
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
13
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
12
num Events
0
group Id
EG006
num Affected
0
num At Risk
12
num Events
0
group Id
EG007
num Affected
0
num At Risk
12
num Events
0
group Id
EG008
num Affected
0
num At Risk
13
num Events
0
group Id
EG009
num Affected
0
num At Risk
18
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
16
num Events
0
term
Parainfluenzae virus infection

time Frame

All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to Month 53 for Main Study Phase and from Month 53 up to Month 65, which marks the completion of the PACT Phase for all participants.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice