NCT01190644 · ADVERSE EVENTS

Adverse events

Study to Evaluate Effect of a Single Dose of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Participants With Solid Tumors · Source last updated 2023-11-29

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: Up to approximately 7 months
Other-event reporting threshold: 5%

The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Sotatercept 35 mg Participants received a single 35 mg dose of sotatercept by SC injection on Day 1, Day 43, and Day 85.	3 / 4	4 / 4	2 / 5

Group identifiers: EG000: Sotatercept 35 mg

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
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
CARDIO-RESPIRATORY ARREST
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
CARDIOGENIC SHOCK
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
PNEUMOPERITONEUM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
DEVICE DISLOCATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
INFECTED SKIN ULCER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
term
PROCEDURAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
DEHYDRATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
HYPONATRAEMIA

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 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
MYOCARDIAL INFARCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
ABDOMINAL DISTENSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
ASCITES
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
GASTROOESOPHAGEAL REFLUX DISEASE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
NAUSEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
3
num At Risk
4
num Events
3
term
VOMITING
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
2
term
OEDEMA PERIPHERAL
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
DEVICE RELATED INFECTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
ESCHERICHIA INFECTION

Complete source fields

description

The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.

event Groups

deaths Num Affected
2
deaths Num At Risk
5
description
Participants received a single 35 mg dose of sotatercept by SC injection on Day 1, Day 43, and Day 85.
id
EG000
other Num Affected
4
other Num At Risk
4
serious Num Affected
3
serious Num At Risk
4
title
Sotatercept 35 mg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
MYOCARDIAL INFARCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
ABDOMINAL DISTENSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
ASCITES
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
GASTROOESOPHAGEAL REFLUX DISEASE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
NAUSEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
3
num At Risk
4
num Events
3
term
VOMITING
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
2
term
OEDEMA PERIPHERAL
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
DEVICE RELATED INFECTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
ESCHERICHIA INFECTION

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
CARDIO-RESPIRATORY ARREST
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
CARDIOGENIC SHOCK
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
PNEUMOPERITONEUM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
DEVICE DISLOCATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
INFECTED SKIN ULCER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
term
PROCEDURAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
DEHYDRATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
term
HYPONATRAEMIA

time Frame

Up to approximately 7 months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice