NCT02499770 · OUTCOME
Change From Baseline of Platelet Count at the End of Cycle 6, Part 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- x 10^9 cells/L
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, Day 1, Day 3, Day 8, Day 10, and Day 15 of a 21-day cycle x 6
What was measured
Blood samples were collected for local clinical laboratory assessment of platelet count.
Analysis population: The FAS included all randomized patients who received at least 1 dose of study drug (etoposide, carboplatin, or trilaciclib). Analyses using the FAS were conducted on the basis of the assigned treatment.
Groups in this outcome
Part 1: Cohort 1 Trilaciclib 200 mg/m^2
Participants received trilaciclib 200 mg/m\^2 administered intravenously (IV) once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
Part 1: Cohort 2 Trilaciclib 240mg/m^2
Participants received trilaciclib 240 mg/m\^2 administered IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
| Group | Source count |
|---|---|
| Part 1: Cohort 1 Trilaciclib 200 mg/m^2 | 5 |
| Part 1: Cohort 2 Trilaciclib 240mg/m^2 | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Cohort 1 Trilaciclib 200 mg/m^2 | -72.6 | 88.38 | Not reported | Not reported | Not reported |
| Part 1: Cohort 2 Trilaciclib 240mg/m^2 | -59.4 | 108.47 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 88.38
- value
- -72.6
- group Id
- OG001
- spread
- 108.47
- value
- -59.4
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- Blood samples were collected for local clinical laboratory assessment of platelet count.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received trilaciclib 200 mg/m\^2 administered intravenously (IV) once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
- id
- OG000
- title
- Part 1: Cohort 1 Trilaciclib 200 mg/m^2
- description
- Participants received trilaciclib 240 mg/m\^2 administered IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
- id
- OG001
- title
- Part 1: Cohort 2 Trilaciclib 240mg/m^2
- param Type
- MEAN
- population Description
- The FAS included all randomized patients who received at least 1 dose of study drug (etoposide, carboplatin, or trilaciclib). Analyses using the FAS were conducted on the basis of the assigned treatment.
- reporting Status
- POSTED
- time Frame
- Baseline, Day 1, Day 3, Day 8, Day 10, and Day 15 of a 21-day cycle x 6
- title
- Change From Baseline of Platelet Count at the End of Cycle 6, Part 1
- type
- SECONDARY
- unit Of Measure
- x 10^9 cells/L
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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