NCT04383210 · ADVERSE EVENTS

Adverse events

Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors · Source last updated 2025-04-03

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: 3 years, 4 months
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort 1 Enrolled 36 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, excluding prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively. Seribantumab: Anti-HER3 monoclonal antibody	17 / 36	35 / 36	21 / 36
Cohort 2 Enrolled 11 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, including prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively. Seribantumab: Anti-HER3 monoclonal antibody	6 / 11	11 / 11	8 / 11
Cohort 3 Enrolled 7 adult advanced solid tumor patients harboring NRG1 gene fusions lacking an EGF-like domain, who have received prior standard treatment, which may have included prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively. Seribantumab: Anti-HER3 monoclonal antibody	4 / 7	7 / 7	7 / 7

Group identifiers: EG000: Cohort 1 · EG001: Cohort 2 · EG002: Cohort 3

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
stats
group Id
EG000
num Affected
3
num At Risk
36
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
1
num At Risk
7
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
COVID-19 pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Kidney Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Carotid artery insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Cerebrovascular accident
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Encephalopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
1
num At Risk
7
term
Hepatic encephalopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Hypersensitive encephalopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Presyncope
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Seizure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
1
num At Risk
7
term
Ascites

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
23
num At Risk
36
group Id
EG001
num Affected
4
num At Risk
11
group Id
EG002
num Affected
1
num At Risk
7
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
17
num At Risk
36
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
2
num At Risk
7
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
7
num At Risk
36
group Id
EG001
num Affected
2
num At Risk
11
group Id
EG002
num Affected
1
num At Risk
7
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
6
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
2
num At Risk
7
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
6
num At Risk
36
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
6
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
4
num At Risk
36
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
20
num At Risk
36
group Id
EG001
num Affected
4
num At Risk
11
group Id
EG002
num Affected
3
num At Risk
7
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
36
group Id
EG001
num Affected
3
num At Risk
11
group Id
EG002
num Affected
2
num At Risk
7
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
4
num At Risk
36
group Id
EG001
num Affected
2
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
4
num At Risk
36
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
1
num At Risk
7
term
Peripheral edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
6
num At Risk
36
group Id
EG001
num Affected
3
num At Risk
11
group Id
EG002
num Affected
1
num At Risk
7
term
Pruritus

Complete source fields

event Groups

deaths Num Affected
21
deaths Num At Risk
36
description
Enrolled 36 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, excluding prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively. Seribantumab: Anti-HER3 monoclonal antibody
id
EG000
other Num Affected
35
other Num At Risk
36
serious Num Affected
17
serious Num At Risk
36
title
Cohort 1
deaths Num Affected
8
deaths Num At Risk
11
description
Enrolled 11 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, including prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively. Seribantumab: Anti-HER3 monoclonal antibody
id
EG001
other Num Affected
11
other Num At Risk
11
serious Num Affected
6
serious Num At Risk
11
title
Cohort 2
deaths Num Affected
7
deaths Num At Risk
7
description
Enrolled 7 adult advanced solid tumor patients harboring NRG1 gene fusions lacking an EGF-like domain, who have received prior standard treatment, which may have included prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively. Seribantumab: Anti-HER3 monoclonal antibody
id
EG002
other Num Affected
7
other Num At Risk
7
serious Num Affected
4
serious Num At Risk
7
title
Cohort 3

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
23
num At Risk
36
group Id
EG001
num Affected
4
num At Risk
11
group Id
EG002
num Affected
1
num At Risk
7
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
17
num At Risk
36
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
2
num At Risk
7
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
7
num At Risk
36
group Id
EG001
num Affected
2
num At Risk
11
group Id
EG002
num Affected
1
num At Risk
7
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
6
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
2
num At Risk
7
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
6
num At Risk
36
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
6
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
4
num At Risk
36
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
20
num At Risk
36
group Id
EG001
num Affected
4
num At Risk
11
group Id
EG002
num Affected
3
num At Risk
7
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
36
group Id
EG001
num Affected
3
num At Risk
11
group Id
EG002
num Affected
2
num At Risk
7
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
4
num At Risk
36
group Id
EG001
num Affected
2
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
4
num At Risk
36
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
1
num At Risk
7
term
Peripheral edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
6
num At Risk
36
group Id
EG001
num Affected
3
num At Risk
11
group Id
EG002
num Affected
1
num At Risk
7
term
Pruritus

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
3
num At Risk
36
group Id
EG001
num Affected
1
num At Risk
11
group Id
EG002
num Affected
1
num At Risk
7
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
COVID-19 pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Kidney Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Carotid artery insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Cerebrovascular accident
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Encephalopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
1
num At Risk
7
term
Hepatic encephalopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Hypersensitive encephalopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Presyncope
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
0
num At Risk
7
term
Seizure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
11
group Id
EG002
num Affected
1
num At Risk
7
term
Ascites

time Frame

3 years, 4 months

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

Preserved source evidence · Not medical advice