NCT04466891 · ADVERSE EVENTS

Adverse events

A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers · Source last updated 2025-09-15

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 start of dosing of any study drug up until 30 days after last study dose, up to approximately 45 months
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort I Participants with advanced or metastatic biliary tract cancer with HER2 amplification by in situ hybridization (ISH) and HER2 overexpression by immunohistochemistry (IHC) which includes IHC 2+ or 3+	43 / 80	78 / 80	60 / 80
Cohort II Participants with advanced or metastatic biliary tract cancer with HER2 amplification by ISH and HER2 IHC 0 or 1+.	3 / 7	5 / 7	6 / 7

Group identifiers: EG000: Cohort I · EG001: Cohort II

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
Hepatobiliary disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
5
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Jaundice cholestatic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
4
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Biliary obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
3
num At Risk
80
group Id
EG001
num Affected
2
num At Risk
7
term
Cholangitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Jaundice
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Bile duct stenosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Cholecystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Hepatic failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
80
group Id
EG001
num Affected
1
num At Risk
7
term
Hepatitis cholestatic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
4
num At Risk
80
group Id
EG001
num Affected
1
num At Risk
7
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
4
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
80
group Id
EG001
num Affected
1
num At Risk
7
term
Biliary sepsis

Other reported adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
18
num At Risk
80
group Id
EG001
num Affected
3
num At Risk
7
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
80
group Id
EG001
num Affected
1
num At Risk
7
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
80
group Id
EG001
num Affected
1
num At Risk
7
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
16
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
7
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
4
num At Risk
80
group Id
EG001
num Affected
1
num At Risk
7
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
5
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
39
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
80
group Id
EG001
num Affected
1
num At Risk
7
term
Duodenal ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
5
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
14
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
13
num At Risk
80
group Id
EG001
num Affected
1
num At Risk
7
term
Vomiting

Complete source fields

event Groups

deaths Num Affected
60
deaths Num At Risk
80
description
Participants with advanced or metastatic biliary tract cancer with HER2 amplification by in situ hybridization (ISH) and HER2 overexpression by immunohistochemistry (IHC) which includes IHC 2+ or 3+
id
EG000
other Num Affected
78
other Num At Risk
80
serious Num Affected
43
serious Num At Risk
80
title
Cohort I
deaths Num Affected
6
deaths Num At Risk
7
description
Participants with advanced or metastatic biliary tract cancer with HER2 amplification by ISH and HER2 IHC 0 or 1+.
id
EG001
other Num Affected
5
other Num At Risk
7
serious Num Affected
3
serious Num At Risk
7
title
Cohort II

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
18
num At Risk
80
group Id
EG001
num Affected
3
num At Risk
7
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
80
group Id
EG001
num Affected
1
num At Risk
7
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
80
group Id
EG001
num Affected
1
num At Risk
7
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
16
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
7
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
4
num At Risk
80
group Id
EG001
num Affected
1
num At Risk
7
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
5
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
39
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
80
group Id
EG001
num Affected
1
num At Risk
7
term
Duodenal ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
5
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
14
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
13
num At Risk
80
group Id
EG001
num Affected
1
num At Risk
7
term
Vomiting

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
5
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Jaundice cholestatic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
4
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Biliary obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
3
num At Risk
80
group Id
EG001
num Affected
2
num At Risk
7
term
Cholangitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Jaundice
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Bile duct stenosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Cholecystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Hepatic failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
80
group Id
EG001
num Affected
1
num At Risk
7
term
Hepatitis cholestatic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
4
num At Risk
80
group Id
EG001
num Affected
1
num At Risk
7
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
4
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
80
group Id
EG001
num Affected
0
num At Risk
7
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
80
group Id
EG001
num Affected
1
num At Risk
7
term
Biliary sepsis

time Frame

Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 45 months

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

Preserved source evidence · Not medical advice