NCT05064358 · ADVERSE EVENTS

Adverse events

Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2026-05-05

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, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks.
Other-event reporting threshold: 5%

All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	17 / 39	38 / 39	23 / 40
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	17 / 40	36 / 40	23 / 40
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	21 / 39	36 / 39	25 / 40
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	16 / 40	40 / 40	21 / 40
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	4 / 17	16 / 17	5 / 17

Group identifiers: EG000: Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) · EG001: Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W · EG002: Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) · EG003: Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W · EG004: Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)

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 v27.0
stats
group Id
EG000
num Affected
2
num At Risk
39
num Events
2
group Id
EG001
num Affected
3
num At Risk
40
num Events
5
group Id
EG002
num Affected
3
num At Risk
39
num Events
3
group Id
EG003
num Affected
2
num At Risk
40
num Events
2
group Id
EG004
num Affected
1
num At Risk
17
num Events
2
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
1
num At Risk
39
num Events
1
group Id
EG001
num Affected
2
num At Risk
40
num Events
3
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Pneumonia bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
1
num At Risk
40
num Events
1
group Id
EG002
num Affected
1
num At Risk
39
num Events
1
group Id
EG003
num Affected
1
num At Risk
40
num Events
1
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
1
num At Risk
40
num Events
1
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Kidney infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
1
num At Risk
40
num Events
2
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
1
num At Risk
40
num Events
1
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Respiratory tract infection viral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
3
num At Risk
39
num Events
3
group Id
EG001
num Affected
1
num At Risk
40
num Events
1
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
1
num At Risk
40
num Events
1
group Id
EG002
num Affected
1
num At Risk
39
num Events
1
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
1
num At Risk
40
num Events
1
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Streptococcal sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
0
num At Risk
40
num Events
0
group Id
EG002
num Affected
2
num At Risk
39
num Events
2
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
0
num At Risk
40
num Events
0
group Id
EG002
num Affected
1
num At Risk
39
num Events
1
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
COVID-19 pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
0
num At Risk
40
num Events
0
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
1
num At Risk
40
num Events
1
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Cellulitis

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 v27.0
stats
group Id
EG000
num Affected
9
num At Risk
39
num Events
16
group Id
EG001
num Affected
12
num At Risk
40
num Events
15
group Id
EG002
num Affected
12
num At Risk
39
num Events
13
group Id
EG003
num Affected
15
num At Risk
40
num Events
23
group Id
EG004
num Affected
4
num At Risk
17
num Events
4
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
0
num At Risk
40
num Events
0
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
1
num At Risk
17
num Events
1
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
2
num At Risk
40
num Events
2
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
2
num At Risk
40
num Events
2
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
2
num At Risk
39
num Events
2
group Id
EG001
num Affected
0
num At Risk
40
num Events
0
group Id
EG002
num Affected
2
num At Risk
39
num Events
2
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
3
num At Risk
39
num Events
3
group Id
EG001
num Affected
8
num At Risk
40
num Events
11
group Id
EG002
num Affected
3
num At Risk
39
num Events
3
group Id
EG003
num Affected
7
num At Risk
40
num Events
8
group Id
EG004
num Affected
4
num At Risk
17
num Events
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
11
num At Risk
39
num Events
17
group Id
EG001
num Affected
17
num At Risk
40
num Events
26
group Id
EG002
num Affected
13
num At Risk
39
num Events
20
group Id
EG003
num Affected
10
num At Risk
40
num Events
14
group Id
EG004
num Affected
4
num At Risk
17
num Events
4
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
0
num At Risk
40
num Events
0
group Id
EG002
num Affected
1
num At Risk
39
num Events
1
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
1
num At Risk
17
num Events
1
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
5
num At Risk
39
num Events
7
group Id
EG001
num Affected
4
num At Risk
40
num Events
4
group Id
EG002
num Affected
2
num At Risk
39
num Events
3
group Id
EG003
num Affected
7
num At Risk
40
num Events
9
group Id
EG004
num Affected
3
num At Risk
17
num Events
3
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
0
num At Risk
40
num Events
0
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
1
num At Risk
17
num Events
1
term
Corneal epithelial microcysts
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
2
num At Risk
40
num Events
3
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
1
num At Risk
17
num Events
1
term
Corneal erosion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
15
num At Risk
39
num Events
25
group Id
EG001
num Affected
12
num At Risk
40
num Events
17
group Id
EG002
num Affected
12
num At Risk
39
num Events
33
group Id
EG003
num Affected
12
num At Risk
40
num Events
17
group Id
EG004
num Affected
8
num At Risk
17
num Events
14
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
11
num At Risk
39
num Events
20
group Id
EG001
num Affected
9
num At Risk
40
num Events
19
group Id
EG002
num Affected
11
num At Risk
39
num Events
32
group Id
EG003
num Affected
11
num At Risk
40
num Events
21
group Id
EG004
num Affected
5
num At Risk
17
num Events
11
term
Eye irritation

Complete source fields

description

event Groups

deaths Num Affected
23
deaths Num At Risk
40
description
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
id
EG000
other Num Affected
38
other Num At Risk
39
serious Num Affected
17
serious Num At Risk
39
title
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
deaths Num Affected
23
deaths Num At Risk
40
description
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
id
EG001
other Num Affected
36
other Num At Risk
40
serious Num Affected
17
serious Num At Risk
40
title
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
deaths Num Affected
25
deaths Num At Risk
40
description
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
id
EG002
other Num Affected
36
other Num At Risk
39
serious Num Affected
21
serious Num At Risk
39
title
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
deaths Num Affected
21
deaths Num At Risk
40
description
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
id
EG003
other Num Affected
40
other Num At Risk
40
serious Num Affected
16
serious Num At Risk
40
title
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
deaths Num Affected
5
deaths Num At Risk
17
description
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
id
EG004
other Num Affected
16
other Num At Risk
17
serious Num Affected
4
serious Num At Risk
17
title
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
9
num At Risk
39
num Events
16
group Id
EG001
num Affected
12
num At Risk
40
num Events
15
group Id
EG002
num Affected
12
num At Risk
39
num Events
13
group Id
EG003
num Affected
15
num At Risk
40
num Events
23
group Id
EG004
num Affected
4
num At Risk
17
num Events
4
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
0
num At Risk
40
num Events
0
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
1
num At Risk
17
num Events
1
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
2
num At Risk
40
num Events
2
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
2
num At Risk
40
num Events
2
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
2
num At Risk
39
num Events
2
group Id
EG001
num Affected
0
num At Risk
40
num Events
0
group Id
EG002
num Affected
2
num At Risk
39
num Events
2
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
3
num At Risk
39
num Events
3
group Id
EG001
num Affected
8
num At Risk
40
num Events
11
group Id
EG002
num Affected
3
num At Risk
39
num Events
3
group Id
EG003
num Affected
7
num At Risk
40
num Events
8
group Id
EG004
num Affected
4
num At Risk
17
num Events
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
11
num At Risk
39
num Events
17
group Id
EG001
num Affected
17
num At Risk
40
num Events
26
group Id
EG002
num Affected
13
num At Risk
39
num Events
20
group Id
EG003
num Affected
10
num At Risk
40
num Events
14
group Id
EG004
num Affected
4
num At Risk
17
num Events
4
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
0
num At Risk
40
num Events
0
group Id
EG002
num Affected
1
num At Risk
39
num Events
1
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
1
num At Risk
17
num Events
1
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
5
num At Risk
39
num Events
7
group Id
EG001
num Affected
4
num At Risk
40
num Events
4
group Id
EG002
num Affected
2
num At Risk
39
num Events
3
group Id
EG003
num Affected
7
num At Risk
40
num Events
9
group Id
EG004
num Affected
3
num At Risk
17
num Events
3
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
0
num At Risk
40
num Events
0
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
1
num At Risk
17
num Events
1
term
Corneal epithelial microcysts
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
2
num At Risk
40
num Events
3
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
1
num At Risk
17
num Events
1
term
Corneal erosion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
15
num At Risk
39
num Events
25
group Id
EG001
num Affected
12
num At Risk
40
num Events
17
group Id
EG002
num Affected
12
num At Risk
39
num Events
33
group Id
EG003
num Affected
12
num At Risk
40
num Events
17
group Id
EG004
num Affected
8
num At Risk
17
num Events
14
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
11
num At Risk
39
num Events
20
group Id
EG001
num Affected
9
num At Risk
40
num Events
19
group Id
EG002
num Affected
11
num At Risk
39
num Events
32
group Id
EG003
num Affected
11
num At Risk
40
num Events
21
group Id
EG004
num Affected
5
num At Risk
17
num Events
11
term
Eye irritation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
2
num At Risk
39
num Events
2
group Id
EG001
num Affected
3
num At Risk
40
num Events
5
group Id
EG002
num Affected
3
num At Risk
39
num Events
3
group Id
EG003
num Affected
2
num At Risk
40
num Events
2
group Id
EG004
num Affected
1
num At Risk
17
num Events
2
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
1
num At Risk
39
num Events
1
group Id
EG001
num Affected
2
num At Risk
40
num Events
3
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Pneumonia bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
1
num At Risk
40
num Events
1
group Id
EG002
num Affected
1
num At Risk
39
num Events
1
group Id
EG003
num Affected
1
num At Risk
40
num Events
1
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
1
num At Risk
40
num Events
1
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Kidney infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
1
num At Risk
40
num Events
2
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
1
num At Risk
40
num Events
1
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Respiratory tract infection viral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
3
num At Risk
39
num Events
3
group Id
EG001
num Affected
1
num At Risk
40
num Events
1
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
1
num At Risk
40
num Events
1
group Id
EG002
num Affected
1
num At Risk
39
num Events
1
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
1
num At Risk
40
num Events
1
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Streptococcal sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
0
num At Risk
40
num Events
0
group Id
EG002
num Affected
2
num At Risk
39
num Events
2
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
0
num At Risk
40
num Events
0
group Id
EG002
num Affected
1
num At Risk
39
num Events
1
group Id
EG003
num Affected
0
num At Risk
40
num Events
0
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
COVID-19 pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
39
num Events
0
group Id
EG001
num Affected
0
num At Risk
40
num Events
0
group Id
EG002
num Affected
0
num At Risk
39
num Events
0
group Id
EG003
num Affected
1
num At Risk
40
num Events
1
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Cellulitis

time Frame

All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks.

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

Preserved source evidence · Not medical advice