TriangleNCT02499770 · OUTCOME
Occurrence of Dose Reduction in Part 2
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
- From randomization to the end of the treatment period (a minimum of 51 days up to a maximum of 379 days)
What was measured
Dose reductions were not permitted for trilaciclib, per study protocol. Dose reductions for E/P were derived from changes in the protocol-specified dose on the dosing page and corresponded to the reductions for toxicity specified in the protocol. No more than 2 dose reductions of E/P in total were allowed for any participant. Simultaneous reductions in the doses of E/P were counted as 1 dose reduction. For the treatment period, the total number of dose reductions was the number of cycles where there was at least 1 dose reduction.
Analysis population: Safety analysis set - included all enrolled participants (i.e., signed informed consent) who received at least 1 dose of study drug (etoposide, carboplatin, or trilaciclib). Part 1: Cohort 1 Trilaciclib 200 mg/m\^2 included 1 participant from Part 2 and 1 participant from Part 1 240 mg/m\^2 who received 200 mg/m\^2.
Groups in this outcome
Part 2: Placebo
Participants received placebo IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
Part 2: Trilaciclib 240 mg/m^2
Participants received trilaciclib 240 mg/m\^2 IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
| Group | Source count |
|---|---|
| Part 2: Placebo | 37 |
| Part 2: Trilaciclib 240 mg/m^2 | 38 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Placebo | 13 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Trilaciclib 240 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 38
- units
- Participants
- description
- Dose reductions were not permitted for trilaciclib, per study protocol. Dose reductions for E/P were derived from changes in the protocol-specified dose on the dosing page and corresponded to the reductions for toxicity specified in the protocol. No more than 2 dose reductions of E/P in total were allowed for any participant. Simultaneous reductions in the doses of E/P were counted as 1 dose reduction. For the treatment period, the total number of dose reductions was the number of cycles where there was at least 1 dose reduction.
- groups
- description
- Participants received placebo IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
- id
- OG000
- title
- Part 2: Placebo
- description
- Participants received trilaciclib 240 mg/m\^2 IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
- id
- OG001
- title
- Part 2: Trilaciclib 240 mg/m^2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set - included all enrolled participants (i.e., signed informed consent) who received at least 1 dose of study drug (etoposide, carboplatin, or trilaciclib). Part 1: Cohort 1 Trilaciclib 200 mg/m\^2 included 1 participant from Part 2 and 1 participant from Part 1 240 mg/m\^2 who received 200 mg/m\^2.
- reporting Status
- POSTED
- time Frame
- From randomization to the end of the treatment period (a minimum of 51 days up to a maximum of 379 days)
- title
- Occurrence of Dose Reduction in Part 2
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice