NCT03761914 · ADVERSE EVENTS

Adverse events

Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers · Source last updated 2024-11-19

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 event data was collected for 29 months.
Other-event reporting threshold: 5%

All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Ovarian Cancer (OvC) * Metastatic platinum-resistant or refractory OvC previously treated with ≥1 line of prior platinum-containing therapy * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab	5 / 25	25 / 25	7 / 25
Colorectal Cancer (CRC) Metastatic CRC previously treated with ≥ 2 lines of prior systematic chemotherapies Galinpepimut-S + Montanide + GM-CSF + pembrolizumab	0 / 0	0 / 0	0 / 0

Group identifiers: EG000: Ovarian Cancer (OvC) · EG001: Colorectal Cancer (CRC)

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
group Id
EG001
num At Risk
0
term
Pneumonitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
group Id
EG001
num At Risk
0
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
group Id
EG001
num At Risk
0
term
Hydronephrosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
group Id
EG001
num At Risk
0
term
Dyspnoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
group Id
EG001
num At Risk
0
term
Small intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
group Id
EG001
num At Risk
0
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
group Id
EG001
num At Risk
0
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
group Id
EG001
num At Risk
0
term
Back 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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
5
num At Risk
25
num Events
5
group Id
EG001
num At Risk
0
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
9
num At Risk
25
num Events
9
group Id
EG001
num At Risk
0
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
7
num At Risk
25
num Events
7
group Id
EG001
num At Risk
0
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
7
num At Risk
25
num Events
7
group Id
EG001
num At Risk
0
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
6
num At Risk
25
num Events
6
group Id
EG001
num At Risk
0
term
Abdominal distension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
6
num At Risk
25
num Events
6
group Id
EG001
num At Risk
0
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
6
num At Risk
25
num Events
6
group Id
EG001
num At Risk
0
term
Gastroesophageal reflux disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
5
num At Risk
25
num Events
5
group Id
EG001
num At Risk
0
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
4
num At Risk
25
num Events
4
group Id
EG001
num At Risk
0
term
Ascites
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
3
num At Risk
25
num Events
3
group Id
EG001
num At Risk
0
term
Small intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
2
group Id
EG001
num At Risk
0
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
8
num At Risk
25
num Events
8
group Id
EG001
num At Risk
0
term
Fatigue

Complete source fields

description

event Groups

deaths Num Affected
7
deaths Num At Risk
25
description
* Metastatic platinum-resistant or refractory OvC previously treated with ≥1 line of prior platinum-containing therapy * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
id
EG000
other Num Affected
25
other Num At Risk
25
serious Num Affected
5
serious Num At Risk
25
title
Ovarian Cancer (OvC)
deaths Num Affected
0
deaths Num At Risk
0
description
Metastatic CRC previously treated with ≥ 2 lines of prior systematic chemotherapies Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
id
EG001
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Colorectal Cancer (CRC)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
5
num At Risk
25
num Events
5
group Id
EG001
num At Risk
0
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
9
num At Risk
25
num Events
9
group Id
EG001
num At Risk
0
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
7
num At Risk
25
num Events
7
group Id
EG001
num At Risk
0
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
7
num At Risk
25
num Events
7
group Id
EG001
num At Risk
0
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
6
num At Risk
25
num Events
6
group Id
EG001
num At Risk
0
term
Abdominal distension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
6
num At Risk
25
num Events
6
group Id
EG001
num At Risk
0
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
6
num At Risk
25
num Events
6
group Id
EG001
num At Risk
0
term
Gastroesophageal reflux disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
5
num At Risk
25
num Events
5
group Id
EG001
num At Risk
0
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
4
num At Risk
25
num Events
4
group Id
EG001
num At Risk
0
term
Ascites
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
3
num At Risk
25
num Events
3
group Id
EG001
num At Risk
0
term
Small intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
2
group Id
EG001
num At Risk
0
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
8
num At Risk
25
num Events
8
group Id
EG001
num At Risk
0
term
Fatigue

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
group Id
EG001
num At Risk
0
term
Pneumonitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
group Id
EG001
num At Risk
0
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
group Id
EG001
num At Risk
0
term
Hydronephrosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
group Id
EG001
num At Risk
0
term
Dyspnoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
group Id
EG001
num At Risk
0
term
Small intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
group Id
EG001
num At Risk
0
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
group Id
EG001
num At Risk
0
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (23.0)
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
group Id
EG001
num At Risk
0
term
Back pain

time Frame

Adverse event data was collected for 29 months.

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Preserved source evidence · Not medical advice