TriangleNCT00636168 · OUTCOME
Distant Metastasis-Free Survival (DMFS) Rates Per IRC at 1 Year, 2 Years, 3 Years, 4 Years and 5 Years in the ITT Population
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
- 95% Confidence Interval
- Time frame
- At years 1, 2, 3, 4 and 5
What was measured
Yearly distant metastasis-free survival rates, e.g. at 1 year, defined as the probability that a participant was alive at 1 year following randomization, were estimated via the Kaplan-Meier method. Distant Metastasis-Free Survival (DMFS) was programmatically determined based on the first date of distant metastasis provided by the IRC and was defined as the time between the date of randomization and the date of first distant metastasis or death (whatever the cause), whichever occurred first. A participant who died without reported disease distant metastasis was considered to have distant metastasis on the date of death. For those who remained alive and metastasis-free, DMFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment. Participants with disease at baseline were considered to have an event on the day of randomization.
Analysis population: Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization
Groups in this outcome
Ipilimumab 10mg/kg
Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
Placebo
Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
| Group | Source count |
|---|---|
| Ipilimumab 10mg/kg | 475 |
| Placebo | 476 |
Reported measurements
DMFS Rate at 1 Year
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ipilimumab 10mg/kg | 74.27 | Not reported | 69.98 | 78.04 | Not reported |
| Placebo | 65.77 | Not reported | 61.27 | 69.88 | Not reported |
DMFS Rate at 2 Years
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ipilimumab 10mg/kg | 61.48 | Not reported | 56.75 | 65.85 | Not reported |
| Placebo | 53.26 | Not reported | 48.58 | 57.70 | Not reported |
DMFS Rate at 3 Years
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ipilimumab 10mg/kg | 53.90 | Not reported | 49.04 | 58.50 | Not reported |
| Placebo | 45.17 | Not reported | 40.53 | 49.70 | Not reported |
DMFS Rate at 4 Years
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ipilimumab 10mg/kg | 50.19 | Not reported | 45.30 | 54.87 | Not reported |
| Placebo | 41.48 | Not reported | 36.87 | 46.02 | Not reported |
DMFS Rate at 5 Years
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ipilimumab 10mg/kg | 48.29 | Not reported | 43.36 | 53.04 | Not reported |
| Placebo | 38.90 | Not reported | 34.29 | 43.47 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 69.98
- upper Limit
- 78.04
- value
- 74.27
- group Id
- OG001
- lower Limit
- 61.27
- upper Limit
- 69.88
- value
- 65.77
- title
- DMFS Rate at 1 Year
- categories
- measurements
- group Id
- OG000
- lower Limit
- 56.75
- upper Limit
- 65.85
- value
- 61.48
- group Id
- OG001
- lower Limit
- 48.58
- upper Limit
- 57.70
- value
- 53.26
- title
- DMFS Rate at 2 Years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 49.04
- upper Limit
- 58.50
- value
- 53.90
- group Id
- OG001
- lower Limit
- 40.53
- upper Limit
- 49.70
- value
- 45.17
- title
- DMFS Rate at 3 Years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 45.30
- upper Limit
- 54.87
- value
- 50.19
- group Id
- OG001
- lower Limit
- 36.87
- upper Limit
- 46.02
- value
- 41.48
- title
- DMFS Rate at 4 Years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 43.36
- upper Limit
- 53.04
- value
- 48.29
- group Id
- OG001
- lower Limit
- 34.29
- upper Limit
- 43.47
- value
- 38.90
- title
- DMFS Rate at 5 Years
- denoms
- counts
- group Id
- OG000
- value
- 475
- group Id
- OG001
- value
- 476
- units
- Participants
- description
- Yearly distant metastasis-free survival rates, e.g. at 1 year, defined as the probability that a participant was alive at 1 year following randomization, were estimated via the Kaplan-Meier method. Distant Metastasis-Free Survival (DMFS) was programmatically determined based on the first date of distant metastasis provided by the IRC and was defined as the time between the date of randomization and the date of first distant metastasis or death (whatever the cause), whichever occurred first. A participant who died without reported disease distant metastasis was considered to have distant metastasis on the date of death. For those who remained alive and metastasis-free, DMFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment. Participants with disease at baseline were considered to have an event on the day of randomization.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
- id
- OG000
- title
- Ipilimumab 10mg/kg
- description
- Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
- id
- OG001
- title
- Placebo
- param Type
- NUMBER
- population Description
- Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization
- reporting Status
- POSTED
- time Frame
- At years 1, 2, 3, 4 and 5
- title
- Distant Metastasis-Free Survival (DMFS) Rates Per IRC at 1 Year, 2 Years, 3 Years, 4 Years and 5 Years in the ITT Population
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice