TriangleNCT03614728 · OUTCOME
Part 2: Number of Participants With Non-serious Treatment-emergent Adverse Events (Non-STEAEs) and Serious Treatment Emergent Adverse Events (STEAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Up to 3 years and 2 months
What was measured
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. Treatment emergent adverse event (TEAE) is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with non-STEAEs and STEAEs were planned to be assessed.
Analysis population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Groups in this outcome
Part 2-Dose Escalation: GSK3326595+5-Azacitidine
Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
Part 2-Dose Expansion: GSK3326595+5-Azacitidine
Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.
| Group | Source count |
|---|---|
| Part 2-Dose Escalation: GSK3326595+5-Azacitidine | 0 |
| Part 2-Dose Expansion: GSK3326595+5-Azacitidine | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- units
- Participants
- description
- An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. Treatment emergent adverse event (TEAE) is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with non-STEAEs and STEAEs were planned to be assessed.
- groups
- description
- Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
- id
- OG000
- title
- Part 2-Dose Escalation: GSK3326595+5-Azacitidine
- description
- Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.
- id
- OG001
- title
- Part 2-Dose Expansion: GSK3326595+5-Azacitidine
- population Description
- All Treated Population. Data was not collected as no participants were enrolled in Part 2.
- reporting Status
- POSTED
- time Frame
- Up to 3 years and 2 months
- title
- Part 2: Number of Participants With Non-serious Treatment-emergent Adverse Events (Non-STEAEs) and Serious Treatment Emergent Adverse Events (STEAEs)
- type
- PRIMARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice