TriangleNCT02989857 · OUTCOME
Percentage of Participants With Clinically Significant Grade 3 or Higher Vital Signs AEs
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 the study drug up to end of treatment visit for each intervention (Up to approximately 4 Years)
What was measured
Clinically significant vital signs were recorded as adverse events; there were some vital signs reported as Grade 3 or higher adverse events. Grading categories were determined by NCI CTCAE, version 4.03.
Analysis population: 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
Pyrexia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AG-120 | 0.8 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 0.0 | Not reported | Not reported | Not reported | Not reported |
| After Crossover to AG-120 | 2.3 | Not reported | Not reported | Not reported | Not reported |
Weight Decreased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AG-120 | 0.8 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 1.7 | Not reported | Not reported | Not reported | Not reported |
| After Crossover to AG-120 | 0.0 | Not reported | Not reported | Not reported | Not reported |
Hypertension
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AG-120 | 1.6 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 1.7 | Not reported | Not reported | Not reported | Not reported |
| After Crossover to AG-120 | 7.0 | Not reported | Not reported | Not reported | Not reported |
Hypotension
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AG-120 | 1.6 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 1.7 | Not reported | Not reported | Not reported | Not reported |
| After Crossover to AG-120 | 2.3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.8
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 2.3
- title
- Pyrexia
- categories
- measurements
- group Id
- OG000
- value
- 0.8
- group Id
- OG001
- value
- 1.7
- group Id
- OG002
- value
- 0.0
- title
- Weight Decreased
- categories
- measurements
- group Id
- OG000
- value
- 1.6
- group Id
- OG001
- value
- 1.7
- group Id
- OG002
- value
- 7.0
- title
- Hypertension
- categories
- measurements
- group Id
- OG000
- value
- 1.6
- group Id
- OG001
- value
- 1.7
- group Id
- OG002
- value
- 2.3
- title
- Hypotension
- denoms
- counts
- group Id
- OG000
- value
- 123
- group Id
- OG001
- value
- 59
- group Id
- OG002
- value
- 43
- units
- Participants
- description
- Clinically significant vital signs were recorded as adverse events; there were some vital signs reported as Grade 3 or higher adverse events. Grading categories were determined by NCI CTCAE, version 4.03.
- 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
- 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 the study drug up to end of treatment visit for each intervention (Up to approximately 4 Years)
- title
- Percentage of Participants With Clinically Significant Grade 3 or Higher Vital Signs AEs
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice