TriangleNCT01942135 · OUTCOME
Survival Probabilities at Year 1, Year 2, and Year 3
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Survival Probability
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization until death (assessed up to 36 months)
What was measured
One-, Two- or Three-year Survival Probability is defined as the probability of survival 1 year, 2 or 3 years after the date of randomization based on the Kaplan-Meier estimate. Survival time was censored to last date the participant is known to be alive.
Analysis population: The ITT population or full analysis set included all participants who were randomized, with study intervention, regardless of whether participants received the study intervention or received a different drug from that to which they were randomized.
Groups in this outcome
Palbociclib + Fulvestrant
Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles.
Placebo + Fulvestrant
Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 93 cycles.
| Group | Source count |
|---|---|
| Palbociclib + Fulvestrant | 347 |
| Placebo + Fulvestrant | 174 |
Reported measurements
Survival Probability at Year 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib + Fulvestrant | 85.5 | Not reported | 81.3 | 88.9 | Not reported |
| Placebo + Fulvestrant | 84.8 | Not reported | 78.3 | 89.4 | Not reported |
Survival Probability at Year 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib + Fulvestrant | 65.3 | Not reported | 59.9 | 70.2 | Not reported |
| Placebo + Fulvestrant | 57.3 | Not reported | 49.2 | 64.6 | Not reported |
Survival Probability at Year 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib + Fulvestrant | 49.6 | Not reported | 44.0 | 54.9 | Not reported |
| Placebo + Fulvestrant | 40.8 | Not reported | 32.9 | 48.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 81.3
- upper Limit
- 88.9
- value
- 85.5
- group Id
- OG001
- lower Limit
- 78.3
- upper Limit
- 89.4
- value
- 84.8
- title
- Survival Probability at Year 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 59.9
- upper Limit
- 70.2
- value
- 65.3
- group Id
- OG001
- lower Limit
- 49.2
- upper Limit
- 64.6
- value
- 57.3
- title
- Survival Probability at Year 2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 44.0
- upper Limit
- 54.9
- value
- 49.6
- group Id
- OG001
- lower Limit
- 32.9
- upper Limit
- 48.5
- value
- 40.8
- title
- Survival Probability at Year 3
- denoms
- counts
- group Id
- OG000
- value
- 347
- group Id
- OG001
- value
- 174
- units
- Participants
- description
- One-, Two- or Three-year Survival Probability is defined as the probability of survival 1 year, 2 or 3 years after the date of randomization based on the Kaplan-Meier estimate. Survival time was censored to last date the participant is known to be alive.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles.
- id
- OG000
- title
- Palbociclib + Fulvestrant
- description
- Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 93 cycles.
- id
- OG001
- title
- Placebo + Fulvestrant
- param Type
- NUMBER
- population Description
- The ITT population or full analysis set included all participants who were randomized, with study intervention, regardless of whether participants received the study intervention or received a different drug from that to which they were randomized.
- reporting Status
- POSTED
- time Frame
- From randomization until death (assessed up to 36 months)
- title
- Survival Probabilities at Year 1, Year 2, and Year 3
- type
- SECONDARY
- unit Of Measure
- Survival Probability
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice