NCT00304070 · ADVERSE EVENTS

Adverse events

Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor · Source last updated 2024-02-28

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: Not reported
Other-event reporting threshold: 0%

Serious and other adverse events were collected only for Stratum 3 patients who received systemic intervention. Stratum 1 and Stratum 2 patients did not receive chemotherapy as part of protocol treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Stratum 3 Stage III OR IV Disease (chemotherapy)	1 / 39	38 / 39	Not reported / Not reported

Group identifiers: EG000: Stratum 3

Serious adverse events

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

organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
39
num Events
1
term
Pneumonitis

Other reported adverse events

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

organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
39
num Events
1
term
Abdominal infection
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
39
num Events
2
term
Abdominal pain
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
39
num Events
1
term
Acidosis
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
39
num Events
1
term
Activated partial thromboplastin time prolonged
organ System
Endocrine disorders
stats
group Id
EG000
num Affected
5
num At Risk
39
num Events
5
term
Adrenal insufficiency
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
39
num Events
1
term
Agitation
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
39
num Events
3
term
Alanine aminotransferase increased
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
39
num Events
1
term
Allergic reaction
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
39
num Events
1
term
Alopecia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
24
num At Risk
39
num Events
24
term
Anemia
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
7
num At Risk
39
num Events
7
term
Anorexia
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
39
num Events
1
term
Anxiety

Complete source fields

description

event Groups

description
Stage III OR IV Disease (chemotherapy)
id
EG000
other Num Affected
38
other Num At Risk
39
serious Num Affected
1
serious Num At Risk
39
title
Stratum 3

frequency Threshold

other Events

organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
39
num Events
1
term
Abdominal infection
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
39
num Events
2
term
Abdominal pain
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
39
num Events
1
term
Acidosis
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
39
num Events
1
term
Activated partial thromboplastin time prolonged
organ System
Endocrine disorders
stats
group Id
EG000
num Affected
5
num At Risk
39
num Events
5
term
Adrenal insufficiency
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
39
num Events
1
term
Agitation
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
39
num Events
3
term
Alanine aminotransferase increased
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
39
num Events
1
term
Allergic reaction
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
39
num Events
1
term
Alopecia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
24
num At Risk
39
num Events
24
term
Anemia
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
7
num At Risk
39
num Events
7
term
Anorexia
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
39
num Events
1
term
Anxiety

serious Events

organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
39
num Events
1
term
Pneumonitis

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Preserved source evidence · Not medical advice