NCT04579679 · ADVERSE EVENTS

Adverse events

Open-Label Surufatinib in European Patients With NET · Source last updated 2025-07-25

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: Adverse events were collected from the first dose of study drug (Day 1) up to 30 days after last dose of study drug, approximately 33 months. Deaths were collected from screening (Day -28) up to end of follow-up, approximately 36 months
Other-event reporting threshold: 0%

The safety analysis set included all patients who received at least 1 dose of surufatinib.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort A (NET, Lung) Patients with NET of lung origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.	4 / 20	20 / 20	2 / 20
Cohort B (NET, Small Bowel) Patients with NET of small bowel origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.	12 / 32	32 / 32	2 / 32
Cohort C (NET, Other) Patients with NET of non-small bowel, non-pancreas, and non-lung origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.	8 / 20	20 / 20	2 / 20
Cohort D (NET, Any) Patients with NET of any origin received a single dose of drug cocktail (midazolam 2.5 mg, fexofenadine 30 mg and rosuvastatin 10 mg) on Day -2 followed by surufatinib 300 mg orally QD from C1D1 to C1D14. On C1D15, a single dose of surufatinib 300 mg and a single dose of drug cocktail as above was administered. Patients received surufatinib 300 mg orally QD from C1D16 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.	2 / 6	6 / 6	0 / 6

Group identifiers: EG000: Cohort A (NET, Lung) · EG001: Cohort B (NET, Small Bowel) · EG002: Cohort C (NET, Other) · EG003: Cohort D (NET, Any)

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
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
2
num At Risk
32
num Events
2
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
1
num At Risk
32
num Events
1
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
1
num At Risk
32
num Events
1
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
1
num At Risk
32
num Events
1
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Large intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
1
num At Risk
32
num Events
1
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Upper gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
2
num At Risk
32
num Events
2
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
3
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Atrioventricular block
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
1
num At Risk
32
num Events
2
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Malignant neoplasm progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Glioblastoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Tumour haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
2
num At Risk
32
num Events
2
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
General physical health deterioration

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
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
14
num At Risk
20
num Events
49
group Id
EG001
num Affected
20
num At Risk
32
num Events
47
group Id
EG002
num Affected
13
num At Risk
20
num Events
22
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
6
num At Risk
20
num Events
11
group Id
EG001
num Affected
7
num At Risk
32
num Events
12
group Id
EG002
num Affected
4
num At Risk
20
num Events
4
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
group Id
EG001
num Affected
10
num At Risk
32
num Events
17
group Id
EG002
num Affected
1
num At Risk
20
num Events
6
group Id
EG003
num Affected
3
num At Risk
6
num Events
4
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
3
num At Risk
20
num Events
4
group Id
EG001
num Affected
7
num At Risk
32
num Events
9
group Id
EG002
num Affected
3
num At Risk
20
num Events
3
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
2
num At Risk
20
num Events
3
group Id
EG001
num Affected
2
num At Risk
32
num Events
3
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Mucosal inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
2
num At Risk
20
num Events
2
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
term
Influenza like illness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
2
num At Risk
32
num Events
2
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
2
num At Risk
32
num Events
2
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
term
Peripheral swelling
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
11
num At Risk
20
num Events
20
group Id
EG001
num Affected
22
num At Risk
32
num Events
82
group Id
EG002
num Affected
13
num At Risk
20
num Events
24
group Id
EG003
num Affected
2
num At Risk
6
num Events
4
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
5
num At Risk
20
num Events
7
group Id
EG001
num Affected
10
num At Risk
32
num Events
30
group Id
EG002
num Affected
4
num At Risk
20
num Events
6
group Id
EG003
num Affected
3
num At Risk
6
num Events
3
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
2
num At Risk
20
num Events
4
group Id
EG001
num Affected
11
num At Risk
32
num Events
23
group Id
EG002
num Affected
3
num At Risk
20
num Events
3
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Abdominal pain

Complete source fields

description

The safety analysis set included all patients who received at least 1 dose of surufatinib.

event Groups

deaths Num Affected
2
deaths Num At Risk
20
description
Patients with NET of lung origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
id
EG000
other Num Affected
20
other Num At Risk
20
serious Num Affected
4
serious Num At Risk
20
title
Cohort A (NET, Lung)
deaths Num Affected
2
deaths Num At Risk
32
description
Patients with NET of small bowel origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
id
EG001
other Num Affected
32
other Num At Risk
32
serious Num Affected
12
serious Num At Risk
32
title
Cohort B (NET, Small Bowel)
deaths Num Affected
2
deaths Num At Risk
20
description
Patients with NET of non-small bowel, non-pancreas, and non-lung origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
id
EG002
other Num Affected
20
other Num At Risk
20
serious Num Affected
8
serious Num At Risk
20
title
Cohort C (NET, Other)
deaths Num Affected
0
deaths Num At Risk
6
description
Patients with NET of any origin received a single dose of drug cocktail (midazolam 2.5 mg, fexofenadine 30 mg and rosuvastatin 10 mg) on Day -2 followed by surufatinib 300 mg orally QD from C1D1 to C1D14. On C1D15, a single dose of surufatinib 300 mg and a single dose of drug cocktail as above was administered. Patients received surufatinib 300 mg orally QD from C1D16 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
id
EG003
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Cohort D (NET, Any)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
14
num At Risk
20
num Events
49
group Id
EG001
num Affected
20
num At Risk
32
num Events
47
group Id
EG002
num Affected
13
num At Risk
20
num Events
22
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
6
num At Risk
20
num Events
11
group Id
EG001
num Affected
7
num At Risk
32
num Events
12
group Id
EG002
num Affected
4
num At Risk
20
num Events
4
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
group Id
EG001
num Affected
10
num At Risk
32
num Events
17
group Id
EG002
num Affected
1
num At Risk
20
num Events
6
group Id
EG003
num Affected
3
num At Risk
6
num Events
4
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
3
num At Risk
20
num Events
4
group Id
EG001
num Affected
7
num At Risk
32
num Events
9
group Id
EG002
num Affected
3
num At Risk
20
num Events
3
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
2
num At Risk
20
num Events
3
group Id
EG001
num Affected
2
num At Risk
32
num Events
3
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Mucosal inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
2
num At Risk
20
num Events
2
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
term
Influenza like illness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
2
num At Risk
32
num Events
2
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
2
num At Risk
32
num Events
2
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
term
Peripheral swelling
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
11
num At Risk
20
num Events
20
group Id
EG001
num Affected
22
num At Risk
32
num Events
82
group Id
EG002
num Affected
13
num At Risk
20
num Events
24
group Id
EG003
num Affected
2
num At Risk
6
num Events
4
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
5
num At Risk
20
num Events
7
group Id
EG001
num Affected
10
num At Risk
32
num Events
30
group Id
EG002
num Affected
4
num At Risk
20
num Events
6
group Id
EG003
num Affected
3
num At Risk
6
num Events
3
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
2
num At Risk
20
num Events
4
group Id
EG001
num Affected
11
num At Risk
32
num Events
23
group Id
EG002
num Affected
3
num At Risk
20
num Events
3
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Abdominal pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
2
num At Risk
32
num Events
2
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
1
num At Risk
32
num Events
1
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
1
num At Risk
32
num Events
1
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
1
num At Risk
32
num Events
1
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Large intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
1
num At Risk
32
num Events
1
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Upper gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
2
num At Risk
32
num Events
2
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
3
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Atrioventricular block
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
1
num At Risk
32
num Events
2
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Malignant neoplasm progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Glioblastoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
Tumour haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
20
num Events
0
group Id
EG001
num Affected
2
num At Risk
32
num Events
2
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
term
General physical health deterioration

time Frame

Adverse events were collected from the first dose of study drug (Day 1) up to 30 days after last dose of study drug, approximately 33 months. Deaths were collected from screening (Day -28) up to end of follow-up, approximately 36 months

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Preserved source evidence · Not medical advice