NCT00094497 · ADVERSE EVENTS

Adverse events

Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT) · Source last updated 2016-09-21

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 5 years
Other-event reporting threshold: 5%

Other non-serious adverse events were not reliably collected and therefore not reported

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
EDP-M etopodide, doxorubicin, cisplatin and mitotane Etoposide Doxorubicin Cisplatin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)	86 / 148	0 / 0	Not reported / Not reported
Sz-M streptozotocin and mitotane Streptozotocin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)	62 / 149	0 / 0	Not reported / Not reported

Group identifiers: EG000: EDP-M · EG001: Sz-M

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
Endocrine disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
5
num At Risk
148
group Id
EG001
num Affected
1
num At Risk
149
term
adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
17
num At Risk
148
group Id
EG001
num Affected
3
num At Risk
149
term
bone marrow toxicity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
10
num At Risk
148
group Id
EG001
num Affected
0
num At Risk
149
term
cardiovascular or thromboembolic events
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
8
num At Risk
148
group Id
EG001
num Affected
7
num At Risk
149
term
fatigue or general health deterioration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
6
num At Risk
148
group Id
EG001
num Affected
12
num At Risk
149
term
gastrointestinal disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
148
group Id
EG001
num Affected
7
num At Risk
149
term
impaired liver function
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
148
group Id
EG001
num Affected
6
num At Risk
149
term
impaired renal function
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
10
num At Risk
148
group Id
EG001
num Affected
4
num At Risk
149
term
infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
5
num At Risk
148
group Id
EG001
num Affected
4
num At Risk
149
term
neurologic toxicity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
9
num At Risk
148
group Id
EG001
num Affected
5
num At Risk
149
term
respiratory disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
15
num At Risk
148
group Id
EG001
num Affected
13
num At Risk
149
term
Other

Other reported adverse events

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

Complete source fields

description

Other non-serious adverse events were not reliably collected and therefore not reported

event Groups

description
etopodide, doxorubicin, cisplatin and mitotane Etoposide Doxorubicin Cisplatin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)
id
EG000
other Num Affected
0
other Num At Risk
0
serious Num Affected
86
serious Num At Risk
148
title
EDP-M
description
streptozotocin and mitotane Streptozotocin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)
id
EG001
other Num Affected
0
other Num At Risk
0
serious Num Affected
62
serious Num At Risk
149
title
Sz-M

frequency Threshold

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
5
num At Risk
148
group Id
EG001
num Affected
1
num At Risk
149
term
adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
17
num At Risk
148
group Id
EG001
num Affected
3
num At Risk
149
term
bone marrow toxicity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
10
num At Risk
148
group Id
EG001
num Affected
0
num At Risk
149
term
cardiovascular or thromboembolic events
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
8
num At Risk
148
group Id
EG001
num Affected
7
num At Risk
149
term
fatigue or general health deterioration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
6
num At Risk
148
group Id
EG001
num Affected
12
num At Risk
149
term
gastrointestinal disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
148
group Id
EG001
num Affected
7
num At Risk
149
term
impaired liver function
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
148
group Id
EG001
num Affected
6
num At Risk
149
term
impaired renal function
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
10
num At Risk
148
group Id
EG001
num Affected
4
num At Risk
149
term
infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
5
num At Risk
148
group Id
EG001
num Affected
4
num At Risk
149
term
neurologic toxicity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
9
num At Risk
148
group Id
EG001
num Affected
5
num At Risk
149
term
respiratory disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
15
num At Risk
148
group Id
EG001
num Affected
13
num At Risk
149
term
Other

time Frame

up to 5 years

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Preserved source evidence · Not medical advice