TriangleNCT02610777 · OUTCOME
Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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
- From date of first dose up to 30 days after administration of the last dose of any study drug (up to approximately 5 years)
What was measured
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A SAE was defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is an medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. A TEAE was defined as any adverse event occurring after the start of pevonedistat administration of the treatment period.
Analysis population: Safety Population included all enrolled participants who receive at least 1 dose of any study drug azacitidine alone or pevonedistat + azacitidine.
Groups in this outcome
Azacitidine 75 mg/m^2
Azacitidine 75 milligram per square meter (mg/m\^2), infusion, intravenously or subcutaneously, on Days 1 to 5, and on Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2
Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Days 1 to 5, and on Days 8 and 9 and pevonedistat 20 mg/m\^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
| Group | Source count |
|---|---|
| Azacitidine 75 mg/m^2 | 62 |
| Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2 | 58 |
Reported measurements
TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 75 mg/m^2 | 62 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2 | 57 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 75 mg/m^2 | 40 | Not reported | Not reported | Not reported | Not reported |
| Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2 | 40 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 57
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 40
- title
- SAEs
- denoms
- counts
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 58
- units
- Participants
- description
- An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A SAE was defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is an medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. A TEAE was defined as any adverse event occurring after the start of pevonedistat administration of the treatment period.
- groups
- description
- Azacitidine 75 milligram per square meter (mg/m\^2), infusion, intravenously or subcutaneously, on Days 1 to 5, and on Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
- id
- OG000
- title
- Azacitidine 75 mg/m^2
- description
- Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Days 1 to 5, and on Days 8 and 9 and pevonedistat 20 mg/m\^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
- id
- OG001
- title
- Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Population included all enrolled participants who receive at least 1 dose of any study drug azacitidine alone or pevonedistat + azacitidine.
- reporting Status
- POSTED
- time Frame
- From date of first dose up to 30 days after administration of the last dose of any study drug (up to approximately 5 years)
- title
- Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice