TriangleNCT02499770 · OUTCOME
Occurrence of RBC Transfusion 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
Within a cycle, a RBC transfusion event was defined as either 1) an actual RBC transfusion, or 2) eligible for RBC transfusion (defined as hemoglobin \<8.0 g/dL). The occurrence of RBC transfusions was defined as at least 1 cycle with RBC transfusion during the treatment period. For the treatment period, the total number of RBC transfusions was the number of cycles with RBC transfusions. If a participant did not have any RBC transfusions, they were assigned a value of 0.
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 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
Overall
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Placebo | 9 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Trilaciclib 240 mg/m^2 | 6 | Not reported | Not reported | Not reported | Not reported |
On/after Week 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Placebo | 9 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Trilaciclib 240 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 6
- title
- Overall
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 2
- title
- On/after Week 5
- denoms
- counts
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 38
- units
- Participants
- description
- Within a cycle, a RBC transfusion event was defined as either 1) an actual RBC transfusion, or 2) eligible for RBC transfusion (defined as hemoglobin \<8.0 g/dL). The occurrence of RBC transfusions was defined as at least 1 cycle with RBC transfusion during the treatment period. For the treatment period, the total number of RBC transfusions was the number of cycles with RBC transfusions. If a participant did not have any RBC transfusions, they were assigned a value of 0.
- 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
- 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
- Occurrence of RBC Transfusion in Part 2
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice