NCT03837899 · ADVERSE EVENTS

Adverse events

Durvalumab and Tremelimumab for Pediatric Malignancies · Source last updated 2026-07-07

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: From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023)
Other-event reporting threshold: 5%

The safety analysis set included all participants who received any amount of study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	1 / 7	6 / 7	6 / 7
Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	1 / 11	11 / 11	8 / 11
Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	0 / 3	3 / 3	3 / 3
Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	1 / 8	7 / 8	7 / 8
SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	6 / 11	8 / 11	8 / 11
STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.	3 / 10	9 / 10	7 / 10

Group identifiers: EG000: Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg · EG001: Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg · EG002: Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg · EG003: Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg · EG004: SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg · EG005: STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg

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
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Transverse sinus thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Laryngospasm
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
1
num At Risk
10
num Events
1
term
Pulmonary thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
1
num At Risk
10
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
3
num At Risk
11
num Events
3
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
2
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Gastroenteritis rotavirus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Fall

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
Endocrine disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
2
num At Risk
11
num Events
3
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
8
num Events
1
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
group Id
EG005
num Affected
1
num At Risk
10
num Events
1
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Tumour pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Amputation stump pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Anosmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Dysaesthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
2
group Id
EG001
num Affected
4
num At Risk
11
num Events
5
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
2
num At Risk
8
num Events
7
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
group Id
EG005
num Affected
2
num At Risk
10
num Events
3
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Horner's syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
1
num At Risk
10
num Events
1
term
Hypersomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Hypoaesthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Neuralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Peripheral sensory neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Eyelid oedema

Complete source fields

description

The safety analysis set included all participants who received any amount of study treatment.

event Groups

deaths Num Affected
6
deaths Num At Risk
7
description
Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
id
EG000
other Num Affected
6
other Num At Risk
7
serious Num Affected
1
serious Num At Risk
7
title
Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg
deaths Num Affected
8
deaths Num At Risk
11
description
Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
id
EG001
other Num Affected
11
other Num At Risk
11
serious Num Affected
1
serious Num At Risk
11
title
Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
deaths Num Affected
3
deaths Num At Risk
3
description
Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg
deaths Num Affected
7
deaths Num At Risk
8
description
Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
id
EG003
other Num Affected
7
other Num At Risk
8
serious Num Affected
1
serious Num At Risk
8
title
Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
deaths Num Affected
8
deaths Num At Risk
11
description
Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
id
EG004
other Num Affected
8
other Num At Risk
11
serious Num Affected
6
serious Num At Risk
11
title
SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
deaths Num Affected
7
deaths Num At Risk
10
description
Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
id
EG005
other Num Affected
9
other Num At Risk
10
serious Num Affected
3
serious Num At Risk
10
title
STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
2
num At Risk
11
num Events
3
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
8
num Events
1
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
group Id
EG005
num Affected
1
num At Risk
10
num Events
1
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Tumour pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Amputation stump pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Anosmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Dysaesthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
2
group Id
EG001
num Affected
4
num At Risk
11
num Events
5
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
2
num At Risk
8
num Events
7
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
group Id
EG005
num Affected
2
num At Risk
10
num Events
3
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Horner's syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
1
num At Risk
10
num Events
1
term
Hypersomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Hypoaesthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Neuralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Peripheral sensory neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Eyelid oedema

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Transverse sinus thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Laryngospasm
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
1
num At Risk
10
num Events
1
term
Pulmonary thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
1
num At Risk
10
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
3
num At Risk
11
num Events
3
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
2
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Gastroenteritis rotavirus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
11
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
8
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
group Id
EG005
num Affected
0
num At Risk
10
num Events
0
term
Fall

time Frame

From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice