NCT02804750 · ADVERSE EVENTS

Adverse events

Study to Evaluate CORT125134 in Participants With Cushing's Syndrome · Source last updated 2019-10-15

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: Group 1: up to Week 16; Group 2: up to Week 20
Other-event reporting threshold: 0%

All enrolled participants who received at least 1 dose of study drug

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Group 1: Low-dose Group 100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.	0 / 17	15 / 17	0 / 17
Group 2: High-dose Group 250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4.	4 / 18	18 / 18	0 / 18

Group identifiers: EG000: Group 1: Low-dose Group · EG001: Group 2: High-dose Group

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
Infections and infestations
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
18
term
Pilonidal cyst
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
18
term
Myopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
18
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
18
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
18
term
Polyneuropathy

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
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
4
num At Risk
17
group Id
EG001
num Affected
3
num At Risk
18
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
3
num At Risk
17
group Id
EG001
num Affected
5
num At Risk
18
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
2
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
18
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
2
num At Risk
18
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
18
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
4
num At Risk
18
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
2
num At Risk
18
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
18
term
Haemorrhoids
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
4
num At Risk
18
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
3
num At Risk
18
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
18
term
Gingival hyperpigmentation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
2
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
18
term
Asthenia

Complete source fields

description

All enrolled participants who received at least 1 dose of study drug

event Groups

deaths Num Affected
0
deaths Num At Risk
17
description
100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.
id
EG000
other Num Affected
15
other Num At Risk
17
serious Num Affected
0
serious Num At Risk
17
title
Group 1: Low-dose Group
deaths Num Affected
0
deaths Num At Risk
18
description
250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4.
id
EG001
other Num Affected
18
other Num At Risk
18
serious Num Affected
4
serious Num At Risk
18
title
Group 2: High-dose Group

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
4
num At Risk
17
group Id
EG001
num Affected
3
num At Risk
18
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
3
num At Risk
17
group Id
EG001
num Affected
5
num At Risk
18
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
2
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
18
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
2
num At Risk
18
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
18
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
4
num At Risk
18
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
2
num At Risk
18
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
18
term
Haemorrhoids
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
4
num At Risk
18
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
3
num At Risk
18
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
18
term
Gingival hyperpigmentation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
2
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
18
term
Asthenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
18
term
Pilonidal cyst
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
18
term
Myopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
18
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
18
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
18
term
Polyneuropathy

time Frame

Group 1: up to Week 16; Group 2: up to Week 20

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Preserved source evidence · Not medical advice