TriangleNCT02499770 · OUTCOME
OS in Part 2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- Baseline up until death or a maximum of the time at least 70% OS events observed (a maximum of 4 years)
What was measured
OS was calculated as the time (months) from date of first dose of study drug for participants in Part 2 to the date of death due to any cause. Participants who did not die during the study were censored at the date last known to be alive. Participants lacking data beyond the day of first dose of study drug had their survival time censored at day of first dose of study drug. OS was not censored if a participant received other anti-tumor treatments after the study drugs. Median and inter-quartile range of OS were calculated using the Kaplan-Meier method.
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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Placebo | 10.6 | Not reported | 6.9 | 16.9 | Not reported |
| Part 2: Trilaciclib 240 mg/m^2 | 10.9 | Not reported | 7.3 | 20.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.9
- upper Limit
- 16.9
- value
- 10.6
- group Id
- OG001
- lower Limit
- 7.3
- upper Limit
- 20.1
- value
- 10.9
- denoms
- counts
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 38
- units
- Participants
- description
- OS was calculated as the time (months) from date of first dose of study drug for participants in Part 2 to the date of death due to any cause. Participants who did not die during the study were censored at the date last known to be alive. Participants lacking data beyond the day of first dose of study drug had their survival time censored at day of first dose of study drug. OS was not censored if a participant received other anti-tumor treatments after the study drugs. Median and inter-quartile range of OS were calculated using the Kaplan-Meier method.
- dispersion Type
- Inter-Quartile Range
- 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
- 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
- Baseline up until death or a maximum of the time at least 70% OS events observed (a maximum of 4 years)
- title
- OS in Part 2
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice