NCT01587703 · ADVERSE EVENTS

Adverse events

A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers · Source last updated 2020-03-16

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: Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Other-event reporting threshold: 0%

Adverse events were collected in the All Treated Population.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part1: GSK525762 4 mg QD Participants were administered once daily oral dose of 4 mg GSK525762.	2 / 4	4 / 4	4 / 4
Part 1: GSK525762 8 mg QD Participants were administered once daily oral dose of 8 mg GSK525762.	0 / 1	1 / 1	1 / 1
Part 1: GSK525762 16 mg QD Participants were administered once daily oral dose of 16 mg GSK525762.	0 / 3	3 / 3	3 / 3
Part 1: GSK525762 30 mg QD Participants were administered once daily oral dose of 30 mg GSK525762.	1 / 4	3 / 4	4 / 4
Part 1: GSK525762 60 mg QD Participants were administered once daily oral dose of 60 mg GSK525762.	2 / 9	9 / 9	7 / 9
Part 1: GSK525762 80 mg QD Participants were administered once daily oral dose of 80 mg GSK525762.	21 / 32	31 / 32	30 / 32
Part 1: GSK525762 100 mg QD Participants were administered once daily oral dose of 100 mg GSK525762.	3 / 9	9 / 9	7 / 9
Part 1: GSK525762 20 mg BID Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	0 / 4	4 / 4	1 / 4
Part 1: GSK525762 30 mg BID Participants were administered twice daily oral dose of 30 mg GSK525762.	4 / 10	10 / 10	9 / 10
Part 1: GSK525762 40 mg BID Participants were administered twice daily oral dose of 40 mg GSK525762.	2 / 5	5 / 5	3 / 5
Part 2: Participants With NMC Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762.	6 / 12	11 / 12	8 / 12
Part 2: Participants With SCLC Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762.	9 / 14	14 / 14	12 / 14
Part 2: Participants With CRPC Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762.	16 / 23	23 / 23	21 / 23
Part1: GSK525762 2 mg QD Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.	0 / 3	3 / 3	2 / 3
Part 2: Participants With TNBC Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762.	11 / 19	19 / 19	16 / 19
Part 2: Participants With ER+BC Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762.	15 / 21	21 / 21	17 / 21
Part 2: Participants With GIST Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762.	8 / 13	12 / 13	5 / 13
80mg Amor+6mg Iso/80mg Bes+6mg Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.	3 / 5	5 / 5	1 / 5
80mg Bes+6mg Iso/80mg Amor+6mg Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.	3 / 5	5 / 5	0 / 5

Group identifiers: EG000: Part1: GSK525762 4 mg QD · EG001: Part 1: GSK525762 8 mg QD · EG002: Part 1: GSK525762 16 mg QD · EG003: Part 1: GSK525762 30 mg QD · EG004: Part 1: GSK525762 60 mg QD · EG005: Part 1: GSK525762 80 mg QD · EG006: Part 1: GSK525762 100 mg QD · EG007: Part 1: GSK525762 20 mg BID · EG008: Part 1: GSK525762 30 mg BID · EG009: Part 1: GSK525762 40 mg BID · EG010: Part 2: Participants With NMC · EG011: Part 2: Participants With SCLC · EG012: Part 2: Participants With CRPC · EG013: Part1: GSK525762 2 mg QD · EG014: Part 2: Participants With TNBC · EG015: Part 2: Participants With ER+BC · EG016: Part 2: Participants With GIST · EG017: 80mg Amor+6mg Iso/80mg Bes+6mg · EG018: 80mg Bes+6mg Iso/80mg Amor+6mg

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
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
1
num At Risk
32
num Events
1
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
1
num At Risk
14
num Events
1
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
1
num At Risk
10
num Events
1
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
1
num At Risk
12
num Events
1
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Amylase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
2
num At Risk
32
num Events
2
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
1
num At Risk
10
num Events
1
group Id
EG009
num Affected
1
num At Risk
5
num Events
1
group Id
EG010
num Affected
2
num At Risk
12
num Events
3
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
1
num At Risk
14
num Events
1
term
Anal abscess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
1
num At Risk
14
num Events
1
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
2
num At Risk
32
num Events
2
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
1
num At Risk
5
num Events
1
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
1
num At Risk
32
num Events
1
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Blood creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Cardiotoxicity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
1
num At Risk
12
num Events
1
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Catheter site infection

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 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Abdominal hernia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
4
num At Risk
32
num Events
4
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
2
num At Risk
10
num Events
2
group Id
EG009
num Affected
2
num At Risk
5
num Events
2
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
1
num At Risk
14
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
1
num At Risk
12
num Events
1
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Abdominal pain lower
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
1
num At Risk
32
num Events
1
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
1
num At Risk
10
num Events
1
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
2
num At Risk
12
num Events
2
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Abdominal tenderness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
2
num At Risk
32
num Events
3
group Id
EG006
num Affected
1
num At Risk
9
num Events
1
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
1
num At Risk
10
num Events
1
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
3
num At Risk
32
num Events
3
group Id
EG006
num Affected
1
num At Risk
9
num Events
1
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Acute respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
1
num At Risk
14
num Events
1
term
Ageusia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
1
num At Risk
14
num Events
1
term
Agitation

Complete source fields

description

Adverse events were collected in the All Treated Population.

event Groups

deaths Num Affected
4
deaths Num At Risk
4
description
Participants were administered once daily oral dose of 4 mg GSK525762.
id
EG000
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Part1: GSK525762 4 mg QD
deaths Num Affected
1
deaths Num At Risk
1
description
Participants were administered once daily oral dose of 8 mg GSK525762.
id
EG001
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Part 1: GSK525762 8 mg QD
deaths Num Affected
3
deaths Num At Risk
3
description
Participants were administered once daily oral dose of 16 mg GSK525762.
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Part 1: GSK525762 16 mg QD
deaths Num Affected
4
deaths Num At Risk
4
description
Participants were administered once daily oral dose of 30 mg GSK525762.
id
EG003
other Num Affected
3
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Part 1: GSK525762 30 mg QD
deaths Num Affected
7
deaths Num At Risk
9
description
Participants were administered once daily oral dose of 60 mg GSK525762.
id
EG004
other Num Affected
9
other Num At Risk
9
serious Num Affected
2
serious Num At Risk
9
title
Part 1: GSK525762 60 mg QD
deaths Num Affected
30
deaths Num At Risk
32
description
Participants were administered once daily oral dose of 80 mg GSK525762.
id
EG005
other Num Affected
31
other Num At Risk
32
serious Num Affected
21
serious Num At Risk
32
title
Part 1: GSK525762 80 mg QD
deaths Num Affected
7
deaths Num At Risk
9
description
Participants were administered once daily oral dose of 100 mg GSK525762.
id
EG006
other Num Affected
9
other Num At Risk
9
serious Num Affected
3
serious Num At Risk
9
title
Part 1: GSK525762 100 mg QD
deaths Num Affected
1
deaths Num At Risk
4
description
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
id
EG007
other Num Affected
4
other Num At Risk
4
serious Num Affected
0
serious Num At Risk
4
title
Part 1: GSK525762 20 mg BID
deaths Num Affected
9
deaths Num At Risk
10
description
Participants were administered twice daily oral dose of 30 mg GSK525762.
id
EG008
other Num Affected
10
other Num At Risk
10
serious Num Affected
4
serious Num At Risk
10
title
Part 1: GSK525762 30 mg BID
deaths Num Affected
3
deaths Num At Risk
5
description
Participants were administered twice daily oral dose of 40 mg GSK525762.
id
EG009
other Num Affected
5
other Num At Risk
5
serious Num Affected
2
serious Num At Risk
5
title
Part 1: GSK525762 40 mg BID
deaths Num Affected
8
deaths Num At Risk
12
description
Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762.
id
EG010
other Num Affected
11
other Num At Risk
12
serious Num Affected
6
serious Num At Risk
12
title
Part 2: Participants With NMC
deaths Num Affected
12
deaths Num At Risk
14
description
Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762.
id
EG011
other Num Affected
14
other Num At Risk
14
serious Num Affected
9
serious Num At Risk
14
title
Part 2: Participants With SCLC

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Abdominal hernia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
4
num At Risk
32
num Events
4
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
2
num At Risk
10
num Events
2
group Id
EG009
num Affected
2
num At Risk
5
num Events
2
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
1
num At Risk
14
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
1
num At Risk
12
num Events
1
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Abdominal pain lower
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
1
num At Risk
32
num Events
1
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
1
num At Risk
10
num Events
1
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
2
num At Risk
12
num Events
2
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Abdominal tenderness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
2
num At Risk
32
num Events
3
group Id
EG006
num Affected
1
num At Risk
9
num Events
1
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
1
num At Risk
10
num Events
1
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
3
num At Risk
32
num Events
3
group Id
EG006
num Affected
1
num At Risk
9
num Events
1
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Acute respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
1
num At Risk
14
num Events
1
term
Ageusia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
1
num At Risk
14
num Events
1
term
Agitation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
1
num At Risk
32
num Events
1
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
1
num At Risk
14
num Events
1
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
1
num At Risk
10
num Events
1
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
1
num At Risk
12
num Events
1
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Amylase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
2
num At Risk
32
num Events
2
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
1
num At Risk
10
num Events
1
group Id
EG009
num Affected
1
num At Risk
5
num Events
1
group Id
EG010
num Affected
2
num At Risk
12
num Events
3
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
1
num At Risk
14
num Events
1
term
Anal abscess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
1
num At Risk
14
num Events
1
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
2
num At Risk
32
num Events
2
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
1
num At Risk
5
num Events
1
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
1
num At Risk
32
num Events
1
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Blood creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
0
num At Risk
12
num Events
0
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Cardiotoxicity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
32
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
0
num At Risk
10
num Events
0
group Id
EG009
num Affected
0
num At Risk
5
num Events
0
group Id
EG010
num Affected
1
num At Risk
12
num Events
1
group Id
EG011
num Affected
0
num At Risk
14
num Events
0
term
Catheter site infection

time Frame

Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).

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Preserved source evidence · Not medical advice