TriangleNCT02499770 · OUTCOME
Duration of Grade 3/4 Neutropenia in Part 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- Inter-Quartile Range
- 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
Grade 3/4 neutropenia was defined as at least 1 ANC value \<1.0 × 10\^9/L during the treatment period. Within each cycle, duration (days) of Grade 3/4 neutropenia was defined as the number of days from the date of the first ANC value of \<1.0 × 10\^9/L observed between start of cycle and end of cycle to the date of the first ANC value ≥1.0 × 10\^9/L that met the following criteria: 1) occurred after the ANC value of \<1.0 × 10\^9/L and 2) no other ANC values \<1.0 × 10\^9/L occurred between this day and end of cycle. The duration of Grade 3/4 neutropenia only included participants who had at least 1 Grade 3/4 neutropenia event in the cycle, and censoring rules were applied for unresolved Grade 3/4 neutropenia in a cycle. For the treatment period, the overall duration of Grade 3/4 neutropenia was the median value among the durations of Grade 3/4 neutropenia from all cycles.
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 | 6 |
| Part 1: Cohort 2 Trilaciclib 240mg/m^2 | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Cohort 1 Trilaciclib 200 mg/m^2 | 8 | Not reported | 6 | 10 | Not reported |
| Part 1: Cohort 2 Trilaciclib 240mg/m^2 | 8 | Not reported | 5 | 9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6
- upper Limit
- 10
- value
- 8
- group Id
- OG001
- lower Limit
- 5
- upper Limit
- 9
- value
- 8
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- Grade 3/4 neutropenia was defined as at least 1 ANC value \<1.0 × 10\^9/L during the treatment period. Within each cycle, duration (days) of Grade 3/4 neutropenia was defined as the number of days from the date of the first ANC value of \<1.0 × 10\^9/L observed between start of cycle and end of cycle to the date of the first ANC value ≥1.0 × 10\^9/L that met the following criteria: 1) occurred after the ANC value of \<1.0 × 10\^9/L and 2) no other ANC values \<1.0 × 10\^9/L occurred between this day and end of cycle. The duration of Grade 3/4 neutropenia only included participants who had at least 1 Grade 3/4 neutropenia event in the cycle, and censoring rules were applied for unresolved Grade 3/4 neutropenia in a cycle. For the treatment period, the overall duration of Grade 3/4 neutropenia was the median value among the durations of Grade 3/4 neutropenia from all cycles.
- dispersion Type
- Inter-Quartile Range
- 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
- MEDIAN
- 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
- From randomization to the end of the treatment period (a minimum of 51 days up to a maximum of 379 days)
- title
- Duration of Grade 3/4 Neutropenia in Part 1
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice