NCT04513665 · ADVERSE EVENTS

Adverse events

ZW25 in Women With Endometrial Cancers · Source last updated 2025-05-22

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: 24 weeks from end of treatment, up to 48 weeks
Other-event reporting threshold: 0%

No participants accrued to Stage 2 arm

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Stage 1 Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy. 16 participants will be accrued. If 2 or greater responses are seen, Stage 2 will accrue additional participants. ZW25: ZW25 at 20mg/kg intravenously (IV) every two weeks.	2 / 16	16 / 16	8 / 16
Stage 2 If 2 or greater responses are seen during Stage 1, Stage 2 will accrue an additional 9 participants. Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy. ZW25: ZW25 at 20mg/kg intravenously (IV) every two weeks.	0 / 0	0 / 0	0 / 0

Group identifiers: EG000: Stage 1 · EG001: Stage 2

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
stats
group Id
EG000
num Affected
2
num At Risk
16
group Id
EG001
num At Risk
0
term
Abdominal Pain

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
stats
group Id
EG000
num Affected
1
num At Risk
16
group Id
EG001
num At Risk
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
16
group Id
EG001
num At Risk
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
16
group Id
EG001
num At Risk
0
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
16
group Id
EG001
num At Risk
0
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
16
group Id
EG001
num At Risk
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
7
num At Risk
16
group Id
EG001
num At Risk
0
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
16
group Id
EG001
num At Risk
0
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
16
group Id
EG001
num At Risk
0
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
stats
group Id
EG000
num Affected
1
num At Risk
16
group Id
EG001
num At Risk
0
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
16
group Id
EG001
num At Risk
0
term
Catheter related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
16
group Id
EG001
num At Risk
0
term
Colonic obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
16
group Id
EG001
num At Risk
0
term
Constipation

Complete source fields

description

No participants accrued to Stage 2 arm

event Groups

deaths Num Affected
8
deaths Num At Risk
16
description
Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy. 16 participants will be accrued. If 2 or greater responses are seen, Stage 2 will accrue additional participants. ZW25: ZW25 at 20mg/kg intravenously (IV) every two weeks.
id
EG000
other Num Affected
16
other Num At Risk
16
serious Num Affected
2
serious Num At Risk
16
title
Stage 1
deaths Num Affected
0
deaths Num At Risk
0
description
If 2 or greater responses are seen during Stage 1, Stage 2 will accrue an additional 9 participants. Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy. ZW25: ZW25 at 20mg/kg intravenously (IV) every two weeks.
id
EG001
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Stage 2

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
16
group Id
EG001
num At Risk
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
16
group Id
EG001
num At Risk
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
16
group Id
EG001
num At Risk
0
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
16
group Id
EG001
num At Risk
0
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
16
group Id
EG001
num At Risk
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
7
num At Risk
16
group Id
EG001
num At Risk
0
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
16
group Id
EG001
num At Risk
0
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
16
group Id
EG001
num At Risk
0
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
stats
group Id
EG000
num Affected
1
num At Risk
16
group Id
EG001
num At Risk
0
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
16
group Id
EG001
num At Risk
0
term
Catheter related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
16
group Id
EG001
num At Risk
0
term
Colonic obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
16
group Id
EG001
num At Risk
0
term
Constipation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
16
group Id
EG001
num At Risk
0
term
Abdominal Pain

time Frame

24 weeks from end of treatment, up to 48 weeks

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Preserved source evidence · Not medical advice