TriangleNCT00738582 · OUTCOME
Time to Tumor Response (TTR)
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 the first dose to first documentation of objective response, up to approximately 5 years
What was measured
TTR was derived for those participants with objective evidence of CR or PR. TTR was defined as the time from the date of the first dose of amatuximab to first documentation of objective tumor response. CR was defined as the disappearance of all target lesions with no evidence of tumor elsewhere, and PR was defined as at least a 30% reduction in the total tumor measurement.
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). Here, number of participants analysed included responders (CR or PR).
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 | 29 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 2.3 | Not reported | 2.1 | 3.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.1
- upper Limit
- 3.8
- value
- 2.3
- denoms
- counts
- group Id
- OG000
- value
- 29
- units
- Participants
- description
- TTR was derived for those participants with objective evidence of CR or PR. TTR was defined as the time from the date of the first dose of amatuximab to first documentation of objective tumor response. CR was defined as the disappearance of all target lesions with no evidence of tumor elsewhere, and PR was defined as at least a 30% reduction in the total tumor measurement.
- 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). Here, number of participants analysed included responders (CR or PR).
- reporting Status
- POSTED
- time Frame
- From the date of the first dose to first documentation of objective response, up to approximately 5 years
- title
- Time to Tumor Response (TTR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice