TriangleNCT01943851 · OUTCOME
Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) and AE Leading to Discontinuation (AELD)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 86.9 weeks
What was measured
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect. AELD is adverse events leading to permanent discontinuation of study treatment.
Analysis population: All Treated Population consists of all participants that received at least one dose of study treatment.
Groups in this outcome
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
| Group | Source count |
|---|---|
| Part 1: GSK525762 5 mg QD | 1 |
| Part 1: GSK525762 10 mg QD | 1 |
| Part 1: GSK525762 20 mg QD | 1 |
| Part 1: GSK525762 30 mg QD MM | 5 |
| Part 1: GSK525762 40 mg QD | 1 |
| Part 1: GSK525762 40 mg QD MM | 4 |
| Part 1: GSK525762 60 mg QD AML | 8 |
| Part 1: GSK525762 60 mg QD NHL | 18 |
| Part 1: GSK525762 60 mg QD MM | 3 |
| Part 1: GSK525762 75 mg QD AML | 8 |
| Part 1: GSK525762 80 mg QD | 1 |
| Part 1: GSK525762 80 mg QD AML | 7 |
| Part 1: GSK525762 80 mg QD NHL | 7 |
| Part 1: GSK525762 100 mg QD AML | 16 |
| Part 1: GSK525762 120 mg QD AML | 6 |
Reported measurements
Non-serious AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 5 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 10 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 20 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 30 mg QD MM | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD MM | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD AML | 8 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD NHL | 18 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD MM | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 75 mg QD AML | 8 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD AML | 7 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD NHL | 7 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD AML | 16 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 120 mg QD AML | 6 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 5 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 10 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 20 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 30 mg QD MM | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD MM | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD AML | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD NHL | 12 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD MM | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 75 mg QD AML | 8 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD AML | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD NHL | 7 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD AML | 14 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 120 mg QD AML | 6 | Not reported | Not reported | Not reported | Not reported |
AELD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 5 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 10 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 20 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 30 mg QD MM | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD MM | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD AML | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD NHL | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD MM | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 75 mg QD AML | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD AML | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD NHL | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD AML | 8 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 120 mg QD AML | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 18
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 8
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 7
- title
- Non-serious AEs
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 12
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 8
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 6
- title
- SAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 3
- title
- AELD
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 18
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 8
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 7
- units
- Participants
- description
- An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect. AELD is adverse events leading to permanent discontinuation of study treatment.
- groups
- description
- Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
- id
- OG000
- title
- Part 1: GSK525762 5 mg QD
- description
- Participants were administered once daily oral dose of 10 mg GSK525762.
- id
- OG001
- title
- Part 1: GSK525762 10 mg QD
- description
- Participants were administered once daily oral dose of 20 mg GSK525762.
- id
- OG002
- title
- Part 1: GSK525762 20 mg QD
- description
- Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
- id
- OG003
- title
- Part 1: GSK525762 30 mg QD MM
- description
- Participants were administered once daily oral dose of 40 mg GSK525762.
- id
- OG004
- title
- Part 1: GSK525762 40 mg QD
- description
- Participants with MM were administered once daily oral dose of 40 mg GSK525762.
- id
- OG005
- title
- Part 1: GSK525762 40 mg QD MM
- description
- Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
- id
- OG006
- title
- Part 1: GSK525762 60 mg QD AML
- description
- Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
- id
- OG007
- title
- Part 1: GSK525762 60 mg QD NHL
- description
- Participants with MM were administered once daily oral dose of 60 mg GSK525762.
- id
- OG008
- title
- Part 1: GSK525762 60 mg QD MM
- description
- Participants with AML were administered once daily oral dose of 75 mg GSK525762.
- id
- OG009
- title
- Part 1: GSK525762 75 mg QD AML
- description
- Participants were administered once daily oral dose of 80 mg GSK525762.
- id
- OG010
- title
- Part 1: GSK525762 80 mg QD
- description
- Participants with AML were administered once daily oral dose of 80 mg GSK525762.
- id
- OG011
- title
- Part 1: GSK525762 80 mg QD AML
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All Treated Population consists of all participants that received at least one dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Up to 86.9 weeks
- title
- Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) and AE Leading to Discontinuation (AELD)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice