TriangleNCT03041311 · OUTCOME
Duration of Study Drug Exposure (Induction Period and Maintenance Period)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Days
- Interval / dispersion
- Standard Deviation
- Time frame
- From date of first dose, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 1162 days.
What was measured
Induction period duration of exposure (days) = Day 1 of last induction cycle - Cycle 1 Day 1 of induction phase + 21. Maintenance period duration of exposure (days) = Day 1 of the last maintenance cycle -Cycle 1 Day 1 of maintenance phase + 21.
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
Induction Period
| Group | Source count |
|---|---|
| Trilaciclib+Etoposide/Carboplatin/Atezolizumab | 52 |
| Placebo+Etoposide/Carboplatin/Atezolizumab | 53 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trilaciclib+Etoposide/Carboplatin/Atezolizumab | 83 | 15.6 | Not reported | Not reported | Not reported |
| Placebo+Etoposide/Carboplatin/Atezolizumab | 88 | 20.5 | Not reported | Not reported | Not reported |
Maintenance Period
| Group | Source count |
|---|---|
| Trilaciclib+Etoposide/Carboplatin/Atezolizumab | 41 |
| Placebo+Etoposide/Carboplatin/Atezolizumab | 47 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trilaciclib+Etoposide/Carboplatin/Atezolizumab | 223 | 253.3 | Not reported | Not reported | Not reported |
| Placebo+Etoposide/Carboplatin/Atezolizumab | 232 | 271.0 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 15.6
- value
- 83
- group Id
- OG001
- spread
- 20.5
- value
- 88
- denoms
- counts
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 53
- units
- Participants
- title
- Induction Period
- categories
- measurements
- group Id
- OG000
- spread
- 253.3
- value
- 223
- group Id
- OG001
- spread
- 271.0
- value
- 232
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 47
- units
- Participants
- title
- Maintenance Period
- denoms
- counts
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 53
- units
- Participants
- description
- Induction period duration of exposure (days) = Day 1 of last induction cycle - Cycle 1 Day 1 of induction phase + 21. Maintenance period duration of exposure (days) = Day 1 of the last maintenance cycle -Cycle 1 Day 1 of maintenance phase + 21.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- Safety analysis
- reporting Status
- POSTED
- time Frame
- From date of first dose, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 1162 days.
- title
- Duration of Study Drug Exposure (Induction Period and Maintenance Period)
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice