TriangleNCT02989857 · OUTCOME
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose of study drug up to 28 days after last dose for each intervention (Up to approximately 4 Years)
What was measured
An AE is any untoward medical occurrence associated with the use of a drug in participants, whether or not considered drug related. An AE or suspected adverse reaction is considered serious (an SAE) if it is fatal, life-threatening, causes in-patient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect in a neonate/infant born to a mother or father exposed to study treatment or is an important medical event. Treatment-emergent adverse events are reported.
Analysis population: Safety Analysis Set (SAS) included all participants who received at least one dose of study drug (AG-120 or Placebo).
Groups in this outcome
AG-120
Participants received AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 45 months.
Placebo
Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 7 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.
After Crossover to AG-120
Participants who experienced disease progression and received placebo were allowed to cross over to receive AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle for up to approximately 32 months.
| Group | Source count |
|---|---|
| AG-120 | 123 |
| Placebo | 59 |
| After Crossover to AG-120 | 43 |
Reported measurements
AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AG-120 | 97.6 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 96.6 | Not reported | Not reported | Not reported | Not reported |
| After Crossover to AG-120 | 95.3 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AG-120 | 35.0 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 23.7 | Not reported | Not reported | Not reported | Not reported |
| After Crossover to AG-120 | 27.9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 97.6
- group Id
- OG001
- value
- 96.6
- group Id
- OG002
- value
- 95.3
- title
- AEs
- categories
- measurements
- group Id
- OG000
- value
- 35.0
- group Id
- OG001
- value
- 23.7
- group Id
- OG002
- value
- 27.9
- title
- SAEs
- denoms
- counts
- group Id
- OG000
- value
- 123
- group Id
- OG001
- value
- 59
- group Id
- OG002
- value
- 43
- units
- Participants
- description
- An AE is any untoward medical occurrence associated with the use of a drug in participants, whether or not considered drug related. An AE or suspected adverse reaction is considered serious (an SAE) if it is fatal, life-threatening, causes in-patient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect in a neonate/infant born to a mother or father exposed to study treatment or is an important medical event. Treatment-emergent adverse events are reported.
- groups
- description
- Participants received AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 45 months.
- id
- OG000
- title
- AG-120
- description
- Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 7 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.
- id
- OG001
- title
- Placebo
- description
- Participants who experienced disease progression and received placebo were allowed to cross over to receive AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle for up to approximately 32 months.
- id
- OG002
- title
- After Crossover to AG-120
- param Type
- NUMBER
- population Description
- Safety Analysis Set (SAS) included all participants who received at least one dose of study drug (AG-120 or Placebo).
- reporting Status
- POSTED
- time Frame
- From first dose of study drug up to 28 days after last dose for each intervention (Up to approximately 4 Years)
- title
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice