TriangleNCT02989857 · OUTCOME
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
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
- Baseline
What was measured
The Eastern Cooperative Oncology Group Performance Status (ECOG PS) score classified participants according to their functional impairment, with scores ranging from 0 to 4. ECOG PS: 0 = fully active, able to carry on all pre-disease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work; 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3 = capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = completely disabled, cannot carry on any self-care, totally confined to bed or chair. A higher score means a worse functional status.
Analysis population: ITT population included all participants who were randomized, with the treatment group designated according to the randomization.
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.
| Group | Source count |
|---|---|
| AG-120 | 126 |
| Placebo | 61 |
Reported measurements
0
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AG-120 | 39.7 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 31.1 | Not reported | Not reported | Not reported | Not reported |
1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AG-120 | 59.5 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 67.2 | Not reported | Not reported | Not reported | Not reported |
2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AG-120 | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 1.6 | Not reported | Not reported | Not reported | Not reported |
3
| 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 |
4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AG-120 | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 0.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 39.7
- group Id
- OG001
- value
- 31.1
- title
- 0
- categories
- measurements
- group Id
- OG000
- value
- 59.5
- group Id
- OG001
- value
- 67.2
- title
- 1
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 1.6
- title
- 2
- categories
- measurements
- group Id
- OG000
- value
- 0.8
- group Id
- OG001
- value
- 0.0
- title
- 3
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.0
- title
- 4
- denoms
- counts
- group Id
- OG000
- value
- 126
- group Id
- OG001
- value
- 61
- units
- Participants
- description
- The Eastern Cooperative Oncology Group Performance Status (ECOG PS) score classified participants according to their functional impairment, with scores ranging from 0 to 4. ECOG PS: 0 = fully active, able to carry on all pre-disease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work; 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3 = capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = completely disabled, cannot carry on any self-care, totally confined to bed or chair. A higher score means a worse functional status.
- 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
- param Type
- NUMBER
- population Description
- ITT population included all participants who were randomized, with the treatment group designated according to the randomization.
- reporting Status
- POSTED
- time Frame
- Baseline
- title
- Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice