TriangleNCT00833417 · OUTCOME
Duration of Objective Response (OR) 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 initial OR until the earliest documented disease progression (PD) or death (until clinical cutoff date of 26 November 2010, up to 90 weeks)
What was measured
Duration of OR was defined as the time from the initial CR or PR 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 | 10 |
| Locally Advanced Basal-Cell Carcinoma | 27 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Metastatic Basal-Cell Carcinoma | 7.6 | Not reported | 5.62 | NA | The upper limit of the 95% confidence interval could not be estimated due to the small number of patients who had an objective response. |
| Locally Advanced Basal-Cell Carcinoma | 7.6 | Not reported | 5.65 | 9.66 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper limit of the 95% confidence interval could not be estimated due to the small number of patients who had an objective response.
- group Id
- OG000
- lower Limit
- 5.62
- upper Limit
- NA
- value
- 7.6
- group Id
- OG001
- lower Limit
- 5.65
- upper Limit
- 9.66
- value
- 7.6
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 27
- units
- Participants
- description
- Duration of OR was defined as the time from the initial CR or PR 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 initial OR until the earliest documented disease progression (PD) or death (until clinical cutoff date of 26 November 2010, up to 90 weeks)
- title
- Duration of Objective Response (OR) 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