TriangleNCT00833417 · OUTCOME
Progression-Free Survival (PFS) Determined by the Independent Review Facility
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
- From the initial dose of study drug until the earliest documented disease progression (PD) or death (up to the clinical cutoff date of 28 November 2011, up to 2 years, 5.5 months)
What was measured
PFS was defined as the time from start of treatment to the earliest documented disease progression (PD) or death. Metastatic BCC - PD: ≥ 20% increased sum of the longest diameter (SLD) of targets from nadir, or 1 or more new lesions. Locally advanced BCC - PD: any of: (1) ≥ 20% increased SLD from nadir (radiography or externally visible dimension); (2) new ulceration; (3) new lesions (radiography or physical exam); (4) progression of non-target lesions by radiography.
Analysis population: Efficacy-evaluable population: All treated patients for whom the independent pathologist's interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.
Groups in this outcome
Metastatic Basal-Cell Carcinoma
Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
Locally Advanced Basal-Cell Carcinoma
Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
| Group | Source count |
|---|---|
| Metastatic Basal-Cell Carcinoma | 33 |
| Locally Advanced Basal-Cell Carcinoma | 63 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Metastatic Basal-Cell Carcinoma | 9.5 | Not reported | 7.36 | 11.07 | Not reported |
| Locally Advanced Basal-Cell Carcinoma | 9.5 | Not reported | 7.43 | 14.75 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.36
- upper Limit
- 11.07
- value
- 9.5
- group Id
- OG001
- lower Limit
- 7.43
- upper Limit
- 14.75
- value
- 9.5
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 63
- units
- Participants
- description
- PFS was defined as the time from start of treatment to the earliest documented disease progression (PD) or death. Metastatic BCC - PD: ≥ 20% increased sum of the longest diameter (SLD) of targets from nadir, or 1 or more new lesions. Locally advanced BCC - PD: any of: (1) ≥ 20% increased SLD from nadir (radiography or externally visible dimension); (2) new ulceration; (3) new lesions (radiography or physical exam); (4) progression of non-target lesions by radiography.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
- id
- OG000
- title
- Metastatic Basal-Cell Carcinoma
- description
- Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
- id
- OG001
- title
- Locally Advanced Basal-Cell Carcinoma
- param Type
- MEDIAN
- population Description
- Efficacy-evaluable population: All treated patients for whom the independent pathologist's interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.
- reporting Status
- POSTED
- time Frame
- From the initial dose of study drug until the earliest documented disease progression (PD) or death (up to the clinical cutoff date of 28 November 2011, up to 2 years, 5.5 months)
- title
- Progression-Free Survival (PFS) Determined by the Independent Review Facility
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice