TriangleNCT02367781 · OUTCOME
Percentage of Participants With Adverse Events
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
- Not reported
- Time frame
- Up to approximately 69 months after first patient enrolled
What was measured
Percentage of participants with at least one adverse event. Adverse event onset date before cross over.
Analysis population: The safety-evaluable population included all treated participants, defined as randomized participants who received any protocol treatment. For the safety analyses, participants were grouped according to whether any full or partial dose of atezolizumab was received, including when atezolizumab was received in error. Specifically, for participants randomized to the CnP arm, if atezolizumab was received in error, the participants were grouped to the Atezo+CnP arm for the safety analyses.
Groups in this outcome
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Arm B (Nab-Paclitaxel+Carboplatin)
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
| Group | Source count |
|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 473 |
| Arm B (Nab-Paclitaxel+Carboplatin) | 232 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 99.6 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Nab-Paclitaxel+Carboplatin) | 98.7 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 99.6
- group Id
- OG001
- value
- 98.7
- denoms
- counts
- group Id
- OG000
- value
- 473
- group Id
- OG001
- value
- 232
- units
- Participants
- description
- Percentage of participants with at least one adverse event. Adverse event onset date before cross over.
- groups
- description
- Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
- id
- OG000
- title
- Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
- description
- Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
- id
- OG001
- title
- Arm B (Nab-Paclitaxel+Carboplatin)
- param Type
- NUMBER
- population Description
- The safety-evaluable population included all treated participants, defined as randomized participants who received any protocol treatment. For the safety analyses, participants were grouped according to whether any full or partial dose of atezolizumab was received, including when atezolizumab was received in error. Specifically, for participants randomized to the CnP arm, if atezolizumab was received in error, the participants were grouped to the Atezo+CnP arm for the safety analyses.
- reporting Status
- POSTED
- time Frame
- Up to approximately 69 months after first patient enrolled
- title
- Percentage of Participants With Adverse Events
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice