TriangleNCT04602078 · OUTCOME
Duration of Response (DoR)
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
- Through study completion, average 2 years. CT scans for evaluation will be performed at baseline, on week 9, week 18 and then every 12 weeks (q12w) ± 1w until objective disease progression
What was measured
Time from first confirmed response (CR or PR) to the date of the documented PD as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first.
Analysis population: Patients with CR or PR
Groups in this outcome
AUREA Single-arm
Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit. Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles. Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit. Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles. Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
| Group | Source count |
|---|---|
| AUREA Single-arm | 32 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AUREA Single-arm | 9.2 | Not reported | 5.5 | 16.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.5
- upper Limit
- 16.8
- value
- 9.2
- denoms
- counts
- group Id
- OG000
- value
- 32
- units
- Participants
- description
- Time from first confirmed response (CR or PR) to the date of the documented PD as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit. Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles. Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit. Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles. Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
- id
- OG000
- title
- AUREA Single-arm
- param Type
- MEDIAN
- population Description
- Patients with CR or PR
- reporting Status
- POSTED
- time Frame
- Through study completion, average 2 years. CT scans for evaluation will be performed at baseline, on week 9, week 18 and then every 12 weeks (q12w) ± 1w until objective disease progression
- title
- Duration of Response (DoR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice