NCT01631552 · ADVERSE EVENTS

Adverse events

Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer · Source last updated 2021-08-12

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: First dose date up to 91.88 months plus 30 days - All-Cause Mortality: First dose date up to 91.88 months
Other-event reporting threshold: 5%

Overall Safety Population: All participants who received at least 1 dose of SG. Per planned analysis, data were collected for the Overall Safety Population, pooling all participants regardless of dose level received.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Overall Safety Population All participants who were enrolled in the study and received one dose of sacituzumab govitecan-hziy (SG) at dose level of either 8 mg/kg, 10 mg/kg, 12 mg/kg, or 18 mg/kg of body weight via intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.	192 / 495	490 / 495	422 / 495

Group identifiers: EG000: Overall Safety Population

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
4
num At Risk
495
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
20
num At Risk
495
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
495
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
495
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
495
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
7
num At Risk
495
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
495
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
3
num At Risk
495
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
495
term
Cardiac tamponade
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
495
term
Cardio-respiratory arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
2
num At Risk
495
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
495
term
Inappropriate antidiuretic hormone secretion

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 24.0
stats
group Id
EG000
num Affected
207
num At Risk
495
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
196
num At Risk
495
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
25
num At Risk
495
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
108
num At Risk
495
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
184
num At Risk
495
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
303
num At Risk
495
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
26
num At Risk
495
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
25
num At Risk
495
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
342
num At Risk
495
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
27
num At Risk
495
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
220
num At Risk
495
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
27
num At Risk
495
term
Asthenia

Complete source fields

description

event Groups

deaths Num Affected
422
deaths Num At Risk
495
description
All participants who were enrolled in the study and received one dose of sacituzumab govitecan-hziy (SG) at dose level of either 8 mg/kg, 10 mg/kg, 12 mg/kg, or 18 mg/kg of body weight via intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.
id
EG000
other Num Affected
490
other Num At Risk
495
serious Num Affected
192
serious Num At Risk
495
title
Overall Safety Population

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
207
num At Risk
495
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
196
num At Risk
495
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
25
num At Risk
495
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
108
num At Risk
495
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
184
num At Risk
495
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
303
num At Risk
495
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
26
num At Risk
495
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
25
num At Risk
495
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
342
num At Risk
495
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
27
num At Risk
495
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
220
num At Risk
495
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
27
num At Risk
495
term
Asthenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
4
num At Risk
495
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
20
num At Risk
495
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
495
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
495
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
495
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
7
num At Risk
495
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
495
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
3
num At Risk
495
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
495
term
Cardiac tamponade
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
495
term
Cardio-respiratory arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
2
num At Risk
495
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
495
term
Inappropriate antidiuretic hormone secretion

time Frame

- Adverse Events: First dose date up to 91.88 months plus 30 days - All-Cause Mortality: First dose date up to 91.88 months

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Preserved source evidence · Not medical advice