TriangleNCT02499770 · OUTCOME
PFS Based on Assessments 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, end of every two 21-day cycles, up until disease progression to a maximum of the time at least 70% OS events observed (a maximum of 4 years)
What was measured
Tumor response was assessed by CT or MRI. PFS was defined as the time (months) from date of first dose date of study drug for participants in Part 1 until date of documented disease progression or death due to any cause, whichever occurred first. More specifically, PFS was determined using all the assessment data up until the last evaluable visit prior to or on the date of i) disease progression as defined by RECIST 1.1 or by clinical criteria as determined by the investigator; or ii) withdrawal of consent; or iii) receiving subsequent anticancer therapy, whichever was earlier. For PFS determined using response data derived programmatically, either clinical progression or progression by RECIST (whichever came first) was considered. Median and inter-quartile range of PFS 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 | 5.0 | Not reported | 3.2 | 6.8 | Not reported |
| Part 2: Trilaciclib 240 mg/m^2 | 6.1 | Not reported | 4.2 | 9.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.2
- upper Limit
- 6.8
- value
- 5.0
- group Id
- OG001
- lower Limit
- 4.2
- upper Limit
- 9.5
- value
- 6.1
- denoms
- counts
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 38
- units
- Participants
- description
- Tumor response was assessed by CT or MRI. PFS was defined as the time (months) from date of first dose date of study drug for participants in Part 1 until date of documented disease progression or death due to any cause, whichever occurred first. More specifically, PFS was determined using all the assessment data up until the last evaluable visit prior to or on the date of i) disease progression as defined by RECIST 1.1 or by clinical criteria as determined by the investigator; or ii) withdrawal of consent; or iii) receiving subsequent anticancer therapy, whichever was earlier. For PFS determined using response data derived programmatically, either clinical progression or progression by RECIST (whichever came first) was considered. Median and inter-quartile range of PFS 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, end of every two 21-day cycles, up until disease progression to a maximum of the time at least 70% OS events observed (a maximum of 4 years)
- title
- PFS Based on Assessments in Part 2
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice