NCT03828292 · ADVERSE EVENTS

Adverse events

An Open-label, Dose Escalation Study in Japanese Participants With Relapsed/Refractory Multiple Myeloma Who Have Failed Prior Anti Myeloma Treatments · Source last updated 2025-08-19

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 up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Other-event reporting threshold: 0%

Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.	2 / 4	4 / 4	0 / 4
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.	0 / 4	4 / 4	1 / 4
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter\^2 (m\^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles.	0 / 3	3 / 3	0 / 3
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression.	1 / 4	4 / 4	0 / 4
PACT Phase - ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter\^2 (m\^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles.	1 / 2	0 / 2	0 / 2
PACT Phase - ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dex (Pom/Dex) Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression.	0 / 2	0 / 2	0 / 2

Group identifiers: EG000: Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) · EG001: Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg · EG002: Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) · EG003: Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) · EG004: PACT Phase - ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) · EG005: PACT Phase - ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dex (Pom/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
General disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
1
num At Risk
4
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
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
1
num At Risk
4
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
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Intratumoural haematoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
1
num At Risk
2
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Osteonecrosis

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
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
3
num Events
2
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
1
num At Risk
4
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
3
num Events
3
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
2
num At Risk
4
num Events
4
group Id
EG002
num Affected
3
num At Risk
3
num Events
3
group Id
EG003
num Affected
2
num At Risk
4
num Events
2
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hypoacusis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Asthenopia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Corneal oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
3
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Abnormal faeces

Complete source fields

description

Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).

event Groups

deaths Num Affected
0
deaths Num At Risk
4
description
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
id
EG000
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
deaths Num Affected
1
deaths Num At Risk
4
description
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
id
EG001
other Num Affected
4
other Num At Risk
4
serious Num Affected
0
serious Num At Risk
4
title
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
deaths Num Affected
0
deaths Num At Risk
3
description
Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter\^2 (m\^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles.
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
deaths Num Affected
0
deaths Num At Risk
4
description
Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression.
id
EG003
other Num Affected
4
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
deaths Num Affected
0
deaths Num At Risk
2
description
Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter\^2 (m\^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles.
id
EG004
other Num Affected
0
other Num At Risk
2
serious Num Affected
1
serious Num At Risk
2
title
PACT Phase - ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
deaths Num Affected
0
deaths Num At Risk
2
description
Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression.
id
EG005
other Num Affected
0
other Num At Risk
2
serious Num Affected
0
serious Num At Risk
2
title
PACT Phase - ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dex (Pom/Dex)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
3
num Events
2
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
1
num At Risk
4
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
3
num Events
3
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
2
num At Risk
4
num Events
4
group Id
EG002
num Affected
3
num At Risk
3
num Events
3
group Id
EG003
num Affected
2
num At Risk
4
num Events
2
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hypoacusis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Asthenopia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Corneal oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
3
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Abnormal faeces

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
1
num At Risk
4
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
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
1
num At Risk
4
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
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Intratumoural haematoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA24.1(P1)26(P2)
stats
group Id
EG000
num Affected
0
num At Risk
4
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
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
1
num At Risk
2
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Osteonecrosis

time Frame

All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.

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

Preserved source evidence · Not medical advice