NCT03548285 · ADVERSE EVENTS

Adverse events

Stereotactic Ablative Radiotherapy for Early-stage Glottic Larynx Cancer · Source last updated 2025-05-22

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: From baseline to 36M post treatment
Other-event reporting threshold: 0%

Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
All Patients All patients on the clinical trial.	2 / 25	25 / 25	4 / 25

Group identifiers: EG000: All Patients

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
Renal and urinary disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Aspiration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Chronic kidney disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
2
term
Dysphagia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Gastroenteritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Hypoglycemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
2
term
Hyponatremia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
INR Increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Lung infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Productive cough
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Hypoxic respiratory failure

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
Gastrointestinal disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
4
num At Risk
25
num Events
4
term
Allergic rhinitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Anxiety
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Arthralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
5
term
Atrial flutter
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Blurred vision
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Bronchial infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
4
term
Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
6
num At Risk
25
num Events
7
term
constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
8
num At Risk
25
num Events
9
term
Cough
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Creatinine increased

Complete source fields

description

Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.

event Groups

deaths Num Affected
4
deaths Num At Risk
25
description
All patients on the clinical trial.
id
EG000
other Num Affected
25
other Num At Risk
25
serious Num Affected
2
serious Num At Risk
25
title
All Patients

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
4
num At Risk
25
num Events
4
term
Allergic rhinitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Anxiety
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Arthralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
5
term
Atrial flutter
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Blurred vision
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Bronchial infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
4
term
Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
6
num At Risk
25
num Events
7
term
constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
8
num At Risk
25
num Events
9
term
Cough
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Creatinine increased

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Aspiration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Chronic kidney disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
2
term
Dysphagia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Gastroenteritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Hypoglycemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
2
term
Hyponatremia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
INR Increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Lung infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Productive cough
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Hypoxic respiratory failure

time Frame

From baseline to 36M post treatment

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Preserved source evidence · Not medical advice