NCT03468218 · ADVERSE EVENTS

Adverse events

Pembrolizumab & Cabozantinib in Patients With Head and Neck Squamous Cell Cancer · Source last updated 2026-01-23

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: 2 years
Other-event reporting threshold: 0%

CTCAE Version 4

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Pembrolizumab, Cabozantinib) Patients receive pembrolizumab IV over 30 minutes on day 1 and cabozantinib PO QD on days 1-21. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cabozantinib: Given PO Pembrolizumab: Given IV	18 / 36	24 / 36	7 / 36

Group identifiers: EG000: Treatment (Pembrolizumab, Cabozantinib)

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
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
Hospitalization-Transanitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
Hospitalization- Low blood pressure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
36
term
Hospitalization-hyponatremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
36
term
Hospiltaization- acute respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
Hospitalization-drug induced hepatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
7
num At Risk
36
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
Hospitalization- Atrial Fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
Hospitalization-hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
36
term
Hospitalization- Aspiration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
Hospitalization- Ulcer in right oropharynx
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
36
term
Hospitalization- Hypercalcemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
Hospitalizaiton- Pancreatitis

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
General disorders
stats
group Id
EG000
num Affected
16
num At Risk
36
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
13
num At Risk
36
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
stats
group Id
EG000
num Affected
12
num At Risk
36
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
11
num At Risk
36
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
10
num At Risk
36
term
Dry Mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
10
num At Risk
36
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
10
num At Risk
36
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
12
num At Risk
36
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
10
num At Risk
36
term
Hyponatremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
9
num At Risk
36
term
Oral Mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
8
num At Risk
36
term
hypomagnesemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
9
num At Risk
36
term
Pain

Complete source fields

description

CTCAE Version 4

event Groups

deaths Num Affected
7
deaths Num At Risk
36
description
Patients receive pembrolizumab IV over 30 minutes on day 1 and cabozantinib PO QD on days 1-21. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cabozantinib: Given PO Pembrolizumab: Given IV
id
EG000
other Num Affected
24
other Num At Risk
36
serious Num Affected
18
serious Num At Risk
36
title
Treatment (Pembrolizumab, Cabozantinib)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
16
num At Risk
36
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
13
num At Risk
36
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
stats
group Id
EG000
num Affected
12
num At Risk
36
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
11
num At Risk
36
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
10
num At Risk
36
term
Dry Mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
10
num At Risk
36
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
10
num At Risk
36
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
12
num At Risk
36
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
10
num At Risk
36
term
Hyponatremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
9
num At Risk
36
term
Oral Mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
8
num At Risk
36
term
hypomagnesemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
9
num At Risk
36
term
Pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
Hospitalization-Transanitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
Hospitalization- Low blood pressure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
36
term
Hospitalization-hyponatremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
36
term
Hospiltaization- acute respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
Hospitalization-drug induced hepatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
7
num At Risk
36
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
Hospitalization- Atrial Fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
Hospitalization-hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
36
term
Hospitalization- Aspiration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
Hospitalization- Ulcer in right oropharynx
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
36
term
Hospitalization- Hypercalcemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
Hospitalizaiton- Pancreatitis

time Frame

2 years

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

Preserved source evidence · Not medical advice