TriangleNCT04602078 · OUTCOME
Adverse Events Frequency (Safety)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Through study completion, average 2 years
What was measured
Frequency of adverse events (AEs) reported classified by type and severity.
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 | 66 |
Reported measurements
Any grade AE
Experienced AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AUREA Single-arm | 66 | Not reported | Not reported | Not reported | Not reported |
Did not experience AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AUREA Single-arm | 0 | Not reported | Not reported | Not reported | Not reported |
AE Grade >=3
Experienced AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AUREA Single-arm | 62 | Not reported | Not reported | Not reported | Not reported |
Did not experience AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AUREA Single-arm | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 66
- title
- Experienced AEs
- measurements
- group Id
- OG000
- value
- 0
- title
- Did not experience AEs
- title
- Any grade AE
- categories
- measurements
- group Id
- OG000
- value
- 62
- title
- Experienced AEs
- measurements
- group Id
- OG000
- value
- 4
- title
- Did not experience AEs
- title
- AE Grade >=3
- denoms
- counts
- group Id
- OG000
- value
- 66
- units
- Participants
- description
- Frequency of adverse events (AEs) reported classified by type and severity.
- 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
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Through study completion, average 2 years
- title
- Adverse Events Frequency (Safety)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice