TriangleNCT00738582 · OUTCOME
Overall Progression Free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the date of first dose of amatuximab to the date of disease progression, up to approximately 5 years
What was measured
Overall PFS was defined as the time from the date of first dose of amatuximab to the date of disease progression or death due to any cause. In the absence of confirmation of death, the survival time was censored at the date of the last follow-up contact. Tumor assessments performed up to the initiation of further anticancer therapy were considered. PD as measured by Modified RECIST was defined as an increase of at least 20% in the total tumor measurement over the nadir measurement, or the appearance of one or more new lesions.
Analysis population: Primary Efficacy Population: all participants who received at least 1 dose of amatuximab and met key eligibility criteria (had measurable disease at screening, had unresectable disease, and had at least 1 response assessment or died after starting treatment with amatuximab).
Groups in this outcome
All Participants
Participants received amatuximab 5 mg/kg, IV infusion on Days 1 and 8 with pemetrexed 500 mg/m\^2, IV infusion on Day 1 and cisplatin 75 mg/ m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy. Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).
| Group | Source count |
|---|---|
| All Participants | 84 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 6.3 | Not reported | 6.0 | 7.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.0
- upper Limit
- 7.8
- value
- 6.3
- denoms
- counts
- group Id
- OG000
- value
- 84
- units
- Participants
- description
- Overall PFS was defined as the time from the date of first dose of amatuximab to the date of disease progression or death due to any cause. In the absence of confirmation of death, the survival time was censored at the date of the last follow-up contact. Tumor assessments performed up to the initiation of further anticancer therapy were considered. PD as measured by Modified RECIST was defined as an increase of at least 20% in the total tumor measurement over the nadir measurement, or the appearance of one or more new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received amatuximab 5 mg/kg, IV infusion on Days 1 and 8 with pemetrexed 500 mg/m\^2, IV infusion on Day 1 and cisplatin 75 mg/ m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy. Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).
- id
- OG000
- title
- All Participants
- param Type
- MEDIAN
- population Description
- Primary Efficacy Population: all participants who received at least 1 dose of amatuximab and met key eligibility criteria (had measurable disease at screening, had unresectable disease, and had at least 1 response assessment or died after starting treatment with amatuximab).
- reporting Status
- POSTED
- time Frame
- From the date of first dose of amatuximab to the date of disease progression, up to approximately 5 years
- title
- Overall Progression Free Survival
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice