NCT04325828 · ADVERSE EVENTS

Adverse events

A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma · Source last updated 2026-08-28

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 13 months
Other-event reporting threshold: 5%

Safety analysis set included all participants who received at least 1 dose of study intervention.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Apalutamide + Goserelin Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.	5 / 31	28 / 31	4 / 31

Group identifiers: EG000: Apalutamide + Goserelin

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Oesophageal Stenosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Cancer Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Cerebral Infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Hydronephrosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Laryngeal Oedema

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 Version 24.0
stats
group Id
EG000
num Affected
4
num At Risk
31
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
3
num At Risk
31
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
6
num At Risk
31
term
Hypothyroidism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
3
num At Risk
31
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
4
num At Risk
31
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
5
num At Risk
31
term
Malaise
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Upper Respiratory Tract Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Radiation Skin Injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Blood Creatinine Increased

Complete source fields

description

Safety analysis set included all participants who received at least 1 dose of study intervention.

event Groups

deaths Num Affected
4
deaths Num At Risk
31
description
Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.
id
EG000
other Num Affected
28
other Num At Risk
31
serious Num Affected
5
serious Num At Risk
31
title
Apalutamide + Goserelin

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
4
num At Risk
31
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
3
num At Risk
31
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
6
num At Risk
31
term
Hypothyroidism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
3
num At Risk
31
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
4
num At Risk
31
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
5
num At Risk
31
term
Malaise
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Upper Respiratory Tract Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Radiation Skin Injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Blood Creatinine Increased

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Oesophageal Stenosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
31
term
Cancer Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Cerebral Infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Hydronephrosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
31
term
Laryngeal Oedema

time Frame

Up to 13 months

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Preserved source evidence · Not medical advice