NCT02664961 · ADVERSE EVENTS

Adverse events

Study of TRC105 and Bevacizumab in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN) · Source last updated 2019-07-23

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: Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, up to approximately 2 years.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
TRC105 and/or Bevacizumab All subjects will begin by receiving single agent TRC105 weekly. In the case of a complete response to single agent TRC105, subjects will continue to receive single agent TRC105 for at least 3 months following complete response. In the case of a partial response (without a complete response) to single agent TRC105, bevacizumab every two weeks will be added. In the absence of a partial or complete response to single agent TRC105, subjects will receive single agent bevacizumab every two weeks. In the absence of a complete response to single agent bevacizumab, or for subjects who have documented disease progression on a prior bevacizumab containing regimen, subjects will receive TRC105 weekly and bevacizumab every two weeks. TRC105: Subjects will begin by receiving TRC105 weekly. Subjects who achieve a complete response on single agent TRC105 may transition to every two week dosing. Bevacizumab: Bevacizumab will be dosed every two weeks.	1 / 3	3 / 3	0 / 3

Group identifiers: EG000: TRC105 and/or Bevacizumab

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
Infections and infestations
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Urinary Tract Infection

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 (14.1)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
7
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
term
Blood Amylase Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Candiduria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Decreased Appetite
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
term
Device Related Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Dry Mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Dyspepsia

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
3
description
All subjects will begin by receiving single agent TRC105 weekly. In the case of a complete response to single agent TRC105, subjects will continue to receive single agent TRC105 for at least 3 months following complete response. In the case of a partial response (without a complete response) to single agent TRC105, bevacizumab every two weeks will be added. In the absence of a partial or complete response to single agent TRC105, subjects will receive single agent bevacizumab every two weeks. In the absence of a complete response to single agent bevacizumab, or for subjects who have documented disease progression on a prior bevacizumab containing regimen, subjects will receive TRC105 weekly and bevacizumab every two weeks. TRC105: Subjects will begin by receiving TRC105 weekly. Subjects who achieve a complete response on single agent TRC105 may transition to every two week dosing. Bevacizumab: Bevacizumab will be dosed every two weeks.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
TRC105 and/or Bevacizumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
7
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
term
Blood Amylase Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Candiduria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Decreased Appetite
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
term
Device Related Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Dry Mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Dyspepsia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Urinary Tract Infection

time Frame

Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, up to approximately 2 years.

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Preserved source evidence · Not medical advice