NCT04322539 · ADVERSE EVENTS

Adverse events

A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer · Source last updated 2025-04-04

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 start of study drug administration up to approximately 40 months
Other-event reporting threshold: 5%

All-Cause Mortality data collected during the study was assessed for all randomized participants. Serious AEs and Non-Serious AEs data were collected based on safety population that included all randomized participants who received at least 1 dose.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Fruquintinib + BSC Group Participants received 5 mg of fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).	173 / 456	446 / 456	411 / 461
Placebo + BSC Group Participants received placebo matched to fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).	88 / 230	205 / 230	203 / 230

Group identifiers: EG000: Fruquintinib + BSC Group · EG001: Placebo + BSC Group

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
7
num At Risk
456
group Id
EG001
num Affected
2
num At Risk
230
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
7
num At Risk
456
group Id
EG001
num Affected
6
num At Risk
230
term
Intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
5
num At Risk
456
group Id
EG001
num Affected
1
num At Risk
230
term
Small intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
4
num At Risk
456
group Id
EG001
num Affected
0
num At Risk
230
term
Rectal haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
3
num At Risk
456
group Id
EG001
num Affected
0
num At Risk
230
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
2
num At Risk
456
group Id
EG001
num Affected
5
num At Risk
230
term
Ileus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
4
num At Risk
456
group Id
EG001
num Affected
0
num At Risk
230
term
Intestinal perforation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
3
num At Risk
456
group Id
EG001
num Affected
3
num At Risk
230
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
1
num At Risk
456
group Id
EG001
num Affected
0
num At Risk
230
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
2
num At Risk
456
group Id
EG001
num Affected
0
num At Risk
230
term
Gastrointestinal haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
2
num At Risk
456
group Id
EG001
num Affected
0
num At Risk
230
term
Small intestinal perforation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
2
num At Risk
456
group Id
EG001
num Affected
1
num At Risk
230
term
Stomatitis

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
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
153
num At Risk
456
group Id
EG001
num Affected
52
num At Risk
230
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
93
num At Risk
456
group Id
EG001
num Affected
37
num At Risk
230
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
62
num At Risk
456
group Id
EG001
num Affected
6
num At Risk
230
term
Mucosal inflammation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
43
num At Risk
456
group Id
EG001
num Affected
22
num At Risk
230
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
23
num At Risk
456
group Id
EG001
num Affected
17
num At Risk
230
term
Oedema peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
113
num At Risk
456
group Id
EG001
num Affected
24
num At Risk
230
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
80
num At Risk
456
group Id
EG001
num Affected
36
num At Risk
230
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
82
num At Risk
456
group Id
EG001
num Affected
43
num At Risk
230
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
75
num At Risk
456
group Id
EG001
num Affected
22
num At Risk
230
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
67
num At Risk
456
group Id
EG001
num Affected
7
num At Risk
230
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
67
num At Risk
456
group Id
EG001
num Affected
25
num At Risk
230
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
35
num At Risk
456
group Id
EG001
num Affected
8
num At Risk
230
term
Abdominal pain upper

Complete source fields

description

event Groups

deaths Num Affected
411
deaths Num At Risk
461
description
Participants received 5 mg of fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
id
EG000
other Num Affected
446
other Num At Risk
456
serious Num Affected
173
serious Num At Risk
456
title
Fruquintinib + BSC Group
deaths Num Affected
203
deaths Num At Risk
230
description
Participants received placebo matched to fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
id
EG001
other Num Affected
205
other Num At Risk
230
serious Num Affected
88
serious Num At Risk
230
title
Placebo + BSC Group

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
153
num At Risk
456
group Id
EG001
num Affected
52
num At Risk
230
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
93
num At Risk
456
group Id
EG001
num Affected
37
num At Risk
230
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
62
num At Risk
456
group Id
EG001
num Affected
6
num At Risk
230
term
Mucosal inflammation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
43
num At Risk
456
group Id
EG001
num Affected
22
num At Risk
230
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
23
num At Risk
456
group Id
EG001
num Affected
17
num At Risk
230
term
Oedema peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
113
num At Risk
456
group Id
EG001
num Affected
24
num At Risk
230
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
80
num At Risk
456
group Id
EG001
num Affected
36
num At Risk
230
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
82
num At Risk
456
group Id
EG001
num Affected
43
num At Risk
230
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
75
num At Risk
456
group Id
EG001
num Affected
22
num At Risk
230
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
67
num At Risk
456
group Id
EG001
num Affected
7
num At Risk
230
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
67
num At Risk
456
group Id
EG001
num Affected
25
num At Risk
230
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
35
num At Risk
456
group Id
EG001
num Affected
8
num At Risk
230
term
Abdominal pain upper

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
7
num At Risk
456
group Id
EG001
num Affected
2
num At Risk
230
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
7
num At Risk
456
group Id
EG001
num Affected
6
num At Risk
230
term
Intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
5
num At Risk
456
group Id
EG001
num Affected
1
num At Risk
230
term
Small intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
4
num At Risk
456
group Id
EG001
num Affected
0
num At Risk
230
term
Rectal haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
3
num At Risk
456
group Id
EG001
num Affected
0
num At Risk
230
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
2
num At Risk
456
group Id
EG001
num Affected
5
num At Risk
230
term
Ileus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
4
num At Risk
456
group Id
EG001
num Affected
0
num At Risk
230
term
Intestinal perforation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
3
num At Risk
456
group Id
EG001
num Affected
3
num At Risk
230
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
1
num At Risk
456
group Id
EG001
num Affected
0
num At Risk
230
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
2
num At Risk
456
group Id
EG001
num Affected
0
num At Risk
230
term
Gastrointestinal haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
2
num At Risk
456
group Id
EG001
num Affected
0
num At Risk
230
term
Small intestinal perforation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0.
stats
group Id
EG000
num Affected
2
num At Risk
456
group Id
EG001
num Affected
1
num At Risk
230
term
Stomatitis

time Frame

From start of study drug administration up to approximately 40 months

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

Preserved source evidence · Independent clinical review pending · Not medical advice