TriangleNCT00426764 · OUTCOME
Change in 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
- participants
- Interval / dispersion
- Not reported
- Time frame
- From Baseline up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.
What was measured
The ECOG scale is as follows: Grade 0: Fully active, able to perform all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory, able to carry out light work; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or chair. Data reported is the shift from Baseline ECOG score to best on-study assessment score.
Analysis population: Safety Population: all participants who received at least 1 dose of romidepsin.
Groups in this outcome
Missing
Participants with a missing best on study ECOG performance score, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Best ECOG = 0
Participants with a best on study ECOG performance score of 0, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Best ECOG = 1
Participants with a best on study ECOG performance score of 1, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Best ECOG = 2
Participants with a best on study ECOG performance score of 2, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Best ECOG = 3
Participants with a best on study ECOG performance score of 3, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Best ECOG = 4
Participants with a best on study ECOG performance score of 4, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
| Group | Source count |
|---|---|
| Missing | 5 |
| Best ECOG = 0 | 40 |
| Best ECOG = 1 | 57 |
| Best ECOG = 2 | 19 |
| Best ECOG = 3 | 6 |
| Best ECOG = 4 | 4 |
Reported measurements
Missing Baseline ECOG Score
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Missing | 1 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 0 | 0 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 4 | 0 | Not reported | Not reported | Not reported | Not reported |
Baseline ECOG Score = 0
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Missing | 2 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 0 | 26 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 1 | 16 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 4 | 1 | Not reported | Not reported | Not reported | Not reported |
Baseline ECOG Score = 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Missing | 1 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 0 | 13 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 1 | 35 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 2 | 12 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 3 | 4 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 4 | 2 | Not reported | Not reported | Not reported | Not reported |
Baseline ECOG Score = 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Missing | 1 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 0 | 1 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 1 | 6 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 3 | 2 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 4 | 1 | Not reported | Not reported | Not reported | Not reported |
Baseline ECOG Score = 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Missing | 0 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 0 | 0 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 4 | 0 | Not reported | Not reported | Not reported | Not reported |
Baseline ECOG Score = 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Missing | 0 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 0 | 0 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Best ECOG = 4 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Missing Baseline ECOG Score
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 26
- group Id
- OG002
- value
- 16
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- title
- Baseline ECOG Score = 0
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 35
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 2
- title
- Baseline ECOG Score = 1
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 1
- title
- Baseline ECOG Score = 2
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Baseline ECOG Score = 3
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Baseline ECOG Score = 4
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 40
- group Id
- OG002
- value
- 57
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 4
- units
- Participants
- description
- The ECOG scale is as follows: Grade 0: Fully active, able to perform all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory, able to carry out light work; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or chair. Data reported is the shift from Baseline ECOG score to best on-study assessment score.
- groups
- description
- Participants with a missing best on study ECOG performance score, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
- id
- OG000
- title
- Missing
- description
- Participants with a best on study ECOG performance score of 0, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
- id
- OG001
- title
- Best ECOG = 0
- description
- Participants with a best on study ECOG performance score of 1, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
- id
- OG002
- title
- Best ECOG = 1
- description
- Participants with a best on study ECOG performance score of 2, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
- id
- OG003
- title
- Best ECOG = 2
- description
- Participants with a best on study ECOG performance score of 3, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
- id
- OG004
- title
- Best ECOG = 3
- description
- Participants with a best on study ECOG performance score of 4, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
- id
- OG005
- title
- Best ECOG = 4
- param Type
- NUMBER
- population Description
- Safety Population: all participants who received at least 1 dose of romidepsin.
- reporting Status
- POSTED
- time Frame
- From Baseline up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.
- title
- Change in Eastern Cooperative Oncology Group (ECOG) Performance Status
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice