TriangleNCT03041311 · OUTCOME
Number of Participants With Any Dose Reductions of Carboplatin and Etoposide (Induction Period)
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
- Induction Period. From date of first dose, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
What was measured
No dose reductions were allowed for trilaciclib or atezolizumab during the study.
Analysis population: Safety analysis
Groups in this outcome
Trilaciclib+Etoposide/Carboplatin/Atezolizumab
Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.
Placebo+Etoposide/Carboplatin/Atezolizumab
Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.
| Group | Source count |
|---|---|
| Trilaciclib+Etoposide/Carboplatin/Atezolizumab | 52 |
| Placebo+Etoposide/Carboplatin/Atezolizumab | 53 |
Reported measurements
Etoposide
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trilaciclib+Etoposide/Carboplatin/Atezolizumab | 3 | Not reported | Not reported | Not reported | Not reported |
| Placebo+Etoposide/Carboplatin/Atezolizumab | 14 | Not reported | Not reported | Not reported | Not reported |
Carboplatin
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trilaciclib+Etoposide/Carboplatin/Atezolizumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Placebo+Etoposide/Carboplatin/Atezolizumab | 13 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 14
- title
- Etoposide
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 13
- title
- Carboplatin
- denoms
- counts
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 53
- units
- Participants
- description
- No dose reductions were allowed for trilaciclib or atezolizumab during the study.
- groups
- description
- Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.
- id
- OG000
- title
- Trilaciclib+Etoposide/Carboplatin/Atezolizumab
- description
- Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.
- id
- OG001
- title
- Placebo+Etoposide/Carboplatin/Atezolizumab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis
- reporting Status
- POSTED
- time Frame
- Induction Period. From date of first dose, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
- title
- Number of Participants With Any Dose Reductions of Carboplatin and Etoposide (Induction Period)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice