TriangleNCT01327053 · OUTCOME
Duration of Response (DoR) Per Site Investigator Review Using mRECIST for laBCC and RECIST 1.1 for mBCC (pEAS)
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
Duration of response is the time from the first observed confirmed response (CR or PR) to disease progression or death due to any reason. Duration of response was for participants with ORR. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. Progressive disease (PD): At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2.
Analysis population: The primary efficacy analysis set (pEAS) was a subset of the full analysis set (FAS) including patients with laBCC with tumors that were adequately assessed by MRI or photography or both, \& including all patients with mBCC included in the FAS which comprised all patients who were assigned study treatment irrespective of receiving it.
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 | 42 |
| LDE225 800mg laBCC | 93 |
| LDE225 200mg mBCC | 13 |
| LDE225 800mg mBCC | 23 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| LDE225 200mg laBCC | 18.2 | Not reported | 12.9 | 23.0 | Not reported |
| LDE225 800mg laBCC | 26.0 | Not reported | 15.7 | 47.3 | Not reported |
| LDE225 200mg mBCC | 18.1 | Not reported | 17.7 | 18.4 | Not reported |
| LDE225 800mg mBCC | 10.2 | Not reported | NA | NA | N/A = Both lower and upper confidence intervals were not estimable as limited numbers of PD or death were observed. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.9
- upper Limit
- 23.0
- value
- 18.2
- group Id
- OG001
- lower Limit
- 15.7
- upper Limit
- 47.3
- value
- 26.0
- group Id
- OG002
- lower Limit
- 17.7
- upper Limit
- 18.4
- value
- 18.1
- comment
- N/A = Both lower and upper confidence intervals were not estimable as limited numbers of PD or death were observed.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- 10.2
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 93
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 23
- units
- Participants
- description
- Duration of response is the time from the first observed confirmed response (CR or PR) to disease progression or death due to any reason. Duration of response was for participants with ORR. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. Progressive disease (PD): At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2.
- 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 primary efficacy analysis set (pEAS) was a subset of the full analysis set (FAS) including patients with laBCC with tumors that were adequately assessed by MRI or photography or both, \& including all patients with mBCC included in the FAS which comprised all patients who were assigned study treatment irrespective of receiving it.
- reporting Status
- POSTED
- time Frame
- 42 months
- title
- Duration of Response (DoR) Per Site Investigator Review Using mRECIST for laBCC and RECIST 1.1 for mBCC (pEAS)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice