NCT04579757 · ADVERSE EVENTS

Adverse events

Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors · Source last updated 2025-05-08

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 treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 9 months for dose escalation phase and approximately 33 months for dose expansion phase. All-cause mortality (deaths) were collected from signing of the informed consent form up to end of follow up, approximately 42 months.
Other-event reporting threshold: 5%

The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.	5 / 6	5 / 6	4 / 6
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.	3 / 6	6 / 6	1 / 6
Dose Expansion Phase: Cohort A: CRC Patients with microsatellite stable, locally advanced or metastatic CRC that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.	9 / 15	14 / 15	14 / 15
Dose Expansion Phase: Cohort B1: Thoracic NETs Patients with thoracic NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.	5 / 10	10 / 10	4 / 10
Dose Expansion Phase: Cohort B2: GEP NETs Patients with GEP NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.	9 / 20	20 / 20	2 / 20
Dose Expansion Phase: Cohort C: SCLC Patients with locally advanced or metastatic SCLC that was previously progressed on first-line chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.	8 / 15	15 / 15	8 / 15
Dose Expansion Phase: Cohort D: GC Patients with microsatellite stable, PD-L1 ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GC) and were previously treated with at least 2 lines of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.	0 / 3	3 / 3	0 / 3
Dose Expansion Phase: Cohort E2: UPS Patients with UPS who progressed on, or had discontinued due to intolerable toxicity to, at least 1 line of standard therapy or were unsuitable for standard frontline cytotoxic chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.	4 / 9	8 / 9	1 / 9
Dose Expansion Phase: Cohort F: ATC Patients with locally advanced or metastatic ATC and who had a BRAFV600E mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.	1 / 3	3 / 3	3 / 3

Group identifiers: EG000: Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab · EG001: Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab · EG002: Dose Expansion Phase: Cohort A: CRC · EG003: Dose Expansion Phase: Cohort B1: Thoracic NETs · EG004: Dose Expansion Phase: Cohort B2: GEP NETs · EG005: Dose Expansion Phase: Cohort C: SCLC · EG006: Dose Expansion Phase: Cohort D: GC · EG007: Dose Expansion Phase: Cohort E2: UPS · EG008: Dose Expansion Phase: Cohort F: ATC

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
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
15
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
20
num Events
1
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
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
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
15
num Events
1
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
group Id
EG004
num Affected
2
num At Risk
20
num Events
2
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
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
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
2
num At Risk
15
num Events
2
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
20
num Events
0
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
15
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
20
num Events
1
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
20
num Events
1
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Enteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
group Id
EG004
num Affected
0
num At Risk
20
num Events
0
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
20
num Events
0
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
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
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
20
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Intestinal perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
15
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
20
num Events
0
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
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
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
15
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
20
num Events
0
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Obstruction gastric
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
group Id
EG004
num Affected
0
num At Risk
20
num Events
0
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Pancreatic fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
15
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
20
num Events
0
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Small intestinal obstruction

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
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
3
num At Risk
6
num Events
3
group Id
EG001
num Affected
3
num At Risk
6
num Events
3
group Id
EG002
num Affected
10
num At Risk
15
num Events
18
group Id
EG003
num Affected
5
num At Risk
10
num Events
10
group Id
EG004
num Affected
12
num At Risk
20
num Events
17
group Id
EG005
num Affected
6
num At Risk
15
num Events
12
group Id
EG006
num Affected
3
num At Risk
3
num Events
4
group Id
EG007
num Affected
4
num At Risk
9
num Events
7
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
3
num At Risk
6
num Events
4
group Id
EG002
num Affected
6
num At Risk
15
num Events
14
group Id
EG003
num Affected
3
num At Risk
10
num Events
15
group Id
EG004
num Affected
11
num At Risk
20
num Events
19
group Id
EG005
num Affected
6
num At Risk
15
num Events
8
group Id
EG006
num Affected
3
num At Risk
3
num Events
7
group Id
EG007
num Affected
4
num At Risk
9
num Events
16
group Id
EG008
num Affected
1
num At Risk
3
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
7
num At Risk
15
num Events
13
group Id
EG003
num Affected
3
num At Risk
10
num Events
4
group Id
EG004
num Affected
6
num At Risk
20
num Events
10
group Id
EG005
num Affected
4
num At Risk
15
num Events
6
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
3
num At Risk
9
num Events
5
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
3
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
3
num At Risk
15
num Events
4
group Id
EG003
num Affected
4
num At Risk
10
num Events
8
group Id
EG004
num Affected
4
num At Risk
20
num Events
6
group Id
EG005
num Affected
5
num At Risk
15
num Events
5
group Id
EG006
num Affected
2
num At Risk
3
num Events
3
group Id
EG007
num Affected
2
num At Risk
9
num Events
2
group Id
EG008
num Affected
0
num At Risk
3
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
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
2
num At Risk
6
num Events
2
group Id
EG002
num Affected
2
num At Risk
15
num Events
4
group Id
EG003
num Affected
2
num At Risk
10
num Events
2
group Id
EG004
num Affected
2
num At Risk
20
num Events
2
group Id
EG005
num Affected
3
num At Risk
15
num Events
3
group Id
EG006
num Affected
1
num At Risk
3
num Events
1
group Id
EG007
num Affected
3
num At Risk
9
num Events
3
group Id
EG008
num Affected
2
num At Risk
3
num Events
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
2
num At Risk
15
num Events
2
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
group Id
EG004
num Affected
2
num At Risk
20
num Events
2
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
9
num Events
1
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
15
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
3
num At Risk
20
num Events
4
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
group Id
EG006
num Affected
1
num At Risk
3
num Events
1
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
2
num At Risk
10
num Events
2
group Id
EG004
num Affected
1
num At Risk
20
num Events
1
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
2
num At Risk
9
num Events
3
group Id
EG008
num Affected
1
num At Risk
3
num Events
1
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
3
num At Risk
15
num Events
4
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
2
num At Risk
20
num Events
3
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
15
num Events
2
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
group Id
EG004
num Affected
0
num At Risk
20
num Events
0
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
9
num Events
1
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
15
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
2
num At Risk
20
num Events
3
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
group Id
EG004
num Affected
0
num At Risk
20
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Dysphagia

Complete source fields

description

The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.

event Groups

deaths Num Affected
4
deaths Num At Risk
6
description
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
id
EG000
other Num Affected
5
other Num At Risk
6
serious Num Affected
5
serious Num At Risk
6
title
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab
deaths Num Affected
1
deaths Num At Risk
6
description
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
id
EG001
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab
deaths Num Affected
14
deaths Num At Risk
15
description
Patients with microsatellite stable, locally advanced or metastatic CRC that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
id
EG002
other Num Affected
14
other Num At Risk
15
serious Num Affected
9
serious Num At Risk
15
title
Dose Expansion Phase: Cohort A: CRC
deaths Num Affected
4
deaths Num At Risk
10
description
Patients with thoracic NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
id
EG003
other Num Affected
10
other Num At Risk
10
serious Num Affected
5
serious Num At Risk
10
title
Dose Expansion Phase: Cohort B1: Thoracic NETs
deaths Num Affected
2
deaths Num At Risk
20
description
Patients with GEP NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
id
EG004
other Num Affected
20
other Num At Risk
20
serious Num Affected
9
serious Num At Risk
20
title
Dose Expansion Phase: Cohort B2: GEP NETs
deaths Num Affected
8
deaths Num At Risk
15
description
Patients with locally advanced or metastatic SCLC that was previously progressed on first-line chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
id
EG005
other Num Affected
15
other Num At Risk
15
serious Num Affected
8
serious Num At Risk
15
title
Dose Expansion Phase: Cohort C: SCLC
deaths Num Affected
0
deaths Num At Risk
3
description
Patients with microsatellite stable, PD-L1 ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GC) and were previously treated with at least 2 lines of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
id
EG006
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Dose Expansion Phase: Cohort D: GC
deaths Num Affected
1
deaths Num At Risk
9
description
Patients with UPS who progressed on, or had discontinued due to intolerable toxicity to, at least 1 line of standard therapy or were unsuitable for standard frontline cytotoxic chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
id
EG007
other Num Affected
8
other Num At Risk
9
serious Num Affected
4
serious Num At Risk
9
title
Dose Expansion Phase: Cohort E2: UPS
deaths Num Affected
3
deaths Num At Risk
3
description
Patients with locally advanced or metastatic ATC and who had a BRAFV600E mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
id
EG008
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Dose Expansion Phase: Cohort F: ATC

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
3
num At Risk
6
num Events
3
group Id
EG001
num Affected
3
num At Risk
6
num Events
3
group Id
EG002
num Affected
10
num At Risk
15
num Events
18
group Id
EG003
num Affected
5
num At Risk
10
num Events
10
group Id
EG004
num Affected
12
num At Risk
20
num Events
17
group Id
EG005
num Affected
6
num At Risk
15
num Events
12
group Id
EG006
num Affected
3
num At Risk
3
num Events
4
group Id
EG007
num Affected
4
num At Risk
9
num Events
7
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
3
num At Risk
6
num Events
4
group Id
EG002
num Affected
6
num At Risk
15
num Events
14
group Id
EG003
num Affected
3
num At Risk
10
num Events
15
group Id
EG004
num Affected
11
num At Risk
20
num Events
19
group Id
EG005
num Affected
6
num At Risk
15
num Events
8
group Id
EG006
num Affected
3
num At Risk
3
num Events
7
group Id
EG007
num Affected
4
num At Risk
9
num Events
16
group Id
EG008
num Affected
1
num At Risk
3
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
7
num At Risk
15
num Events
13
group Id
EG003
num Affected
3
num At Risk
10
num Events
4
group Id
EG004
num Affected
6
num At Risk
20
num Events
10
group Id
EG005
num Affected
4
num At Risk
15
num Events
6
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
3
num At Risk
9
num Events
5
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
3
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
3
num At Risk
15
num Events
4
group Id
EG003
num Affected
4
num At Risk
10
num Events
8
group Id
EG004
num Affected
4
num At Risk
20
num Events
6
group Id
EG005
num Affected
5
num At Risk
15
num Events
5
group Id
EG006
num Affected
2
num At Risk
3
num Events
3
group Id
EG007
num Affected
2
num At Risk
9
num Events
2
group Id
EG008
num Affected
0
num At Risk
3
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
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
2
num At Risk
6
num Events
2
group Id
EG002
num Affected
2
num At Risk
15
num Events
4
group Id
EG003
num Affected
2
num At Risk
10
num Events
2
group Id
EG004
num Affected
2
num At Risk
20
num Events
2
group Id
EG005
num Affected
3
num At Risk
15
num Events
3
group Id
EG006
num Affected
1
num At Risk
3
num Events
1
group Id
EG007
num Affected
3
num At Risk
9
num Events
3
group Id
EG008
num Affected
2
num At Risk
3
num Events
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
2
num At Risk
15
num Events
2
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
group Id
EG004
num Affected
2
num At Risk
20
num Events
2
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
9
num Events
1
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
15
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
3
num At Risk
20
num Events
4
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
group Id
EG006
num Affected
1
num At Risk
3
num Events
1
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
2
num At Risk
10
num Events
2
group Id
EG004
num Affected
1
num At Risk
20
num Events
1
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
2
num At Risk
9
num Events
3
group Id
EG008
num Affected
1
num At Risk
3
num Events
1
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
3
num At Risk
15
num Events
4
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
2
num At Risk
20
num Events
3
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
15
num Events
2
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
group Id
EG004
num Affected
0
num At Risk
20
num Events
0
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
9
num Events
1
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
15
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
2
num At Risk
20
num Events
3
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
group Id
EG004
num Affected
0
num At Risk
20
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Dysphagia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
15
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
20
num Events
1
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
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
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
15
num Events
1
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
group Id
EG004
num Affected
2
num At Risk
20
num Events
2
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
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
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
2
num At Risk
15
num Events
2
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
20
num Events
0
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
15
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
20
num Events
1
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
20
num Events
1
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Enteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
group Id
EG004
num Affected
0
num At Risk
20
num Events
0
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
20
num Events
0
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
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
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
20
num Events
0
group Id
EG005
num Affected
1
num At Risk
15
num Events
1
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Intestinal perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
15
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
20
num Events
0
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
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
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
15
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
20
num Events
0
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Obstruction gastric
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
group Id
EG004
num Affected
0
num At Risk
20
num Events
0
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Pancreatic fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
15
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
20
num Events
0
group Id
EG005
num Affected
0
num At Risk
15
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
9
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
term
Small intestinal obstruction

time Frame

Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 9 months for dose escalation phase and approximately 33 months for dose expansion phase. All-cause mortality (deaths) were collected from signing of the informed consent form up to end of follow up, approximately 42 months.

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Preserved source evidence · Not medical advice