TriangleNCT01327053 · OUTCOME
Progression-free Survival (PFS) Per Central Review Using mRECIST for laBCC and RECIST 1.1 for mBCC (FAS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 42 months
What was measured
Progression-free survival (PFS) is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.
Analysis population: The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients).
Groups in this outcome
LDE225 200mg laBCC
The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
LDE225 800mg laBCC
The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
LDE225 200mg mBCC
The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
LDE225 800mg mBCC
The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
| Group | Source count |
|---|---|
| LDE225 200mg laBCC | 66 |
| LDE225 800mg laBCC | 128 |
| LDE225 200mg mBCC | 13 |
| LDE225 800mg mBCC | 23 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| LDE225 200mg laBCC | 22.1 | Not reported | NA | NA | N/A = Both lower and upper confidence intervals were not estimable as limited numbers of PD or death were observed. |
| LDE225 800mg laBCC | 24.9 | Not reported | 19.2 | 33.4 | Not reported |
| LDE225 200mg mBCC | 13.1 | Not reported | 5.6 | 33.1 | Not reported |
| LDE225 800mg mBCC | 11.1 | Not reported | 7.3 | 16.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- N/A = Both lower and upper confidence intervals were not estimable as limited numbers of PD or death were observed.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 22.1
- group Id
- OG001
- lower Limit
- 19.2
- upper Limit
- 33.4
- value
- 24.9
- group Id
- OG002
- lower Limit
- 5.6
- upper Limit
- 33.1
- value
- 13.1
- group Id
- OG003
- lower Limit
- 7.3
- upper Limit
- 16.6
- value
- 11.1
- denoms
- counts
- group Id
- OG000
- value
- 66
- group Id
- OG001
- value
- 128
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 23
- units
- Participants
- description
- Progression-free survival (PFS) is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
- id
- OG000
- title
- LDE225 200mg laBCC
- description
- The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
- id
- OG001
- title
- LDE225 800mg laBCC
- description
- The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
- id
- OG002
- title
- LDE225 200mg mBCC
- description
- The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
- id
- OG003
- title
- LDE225 800mg mBCC
- param Type
- MEDIAN
- population Description
- The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients).
- reporting Status
- POSTED
- time Frame
- 42 months
- title
- Progression-free Survival (PFS) Per Central Review Using mRECIST for laBCC and RECIST 1.1 for mBCC (FAS)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice