NCT02150213 · ADVERSE EVENTS

Adverse events

Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492 · Source last updated 2016-12-05

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: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
BGG492 This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to \> 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day	5 / 59	3 / 59	Not reported / Not reported

Group identifiers: EG000: BGG492

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
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
3
num At Risk
59
term
Adrenal Adenoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
1
num At Risk
59
term
Angiomyolipoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
1
num At Risk
59
term
Ovarian cyst

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
Renal and urinary disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
3
num At Risk
59
term
Renal Cyst

Complete source fields

event Groups

description
This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to \> 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
id
EG000
other Num Affected
3
other Num At Risk
59
serious Num Affected
5
serious Num At Risk
59
title
BGG492

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
3
num At Risk
59
term
Renal Cyst

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
3
num At Risk
59
term
Adrenal Adenoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
1
num At Risk
59
term
Angiomyolipoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
1
num At Risk
59
term
Ovarian cyst

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Preserved source evidence · Not medical advice