NCT00833417 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- 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
- FG000
- 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
- FG001
- title
- Locally Advanced Basal-Cell Carcinoma
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 16
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 3
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 2
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 7
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 23
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 2
- type
- Sponsor Decision to End the Study
- reasons
- group Id
- FG000
- num Subjects
- 18
- group Id
- FG001
- num Subjects
- 17
- type
- Disease Progression
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Reason Not Specified
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 33
- group Id
- FG001
- num Subjects
- 71
- comment
- All Enrolled Participants
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 33
- group Id
- FG001
- num Subjects
- 71
- comment
- Safety Population
- type
- Received at Least 1 Dose of Study Drug
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 33
- group Id
- FG001
- num Subjects
- 71
- type
- NOT COMPLETED
- title
- Overall Study
- recruitment Details
- The study population consisted of patients ≥ 18 years old with a histologically confirmed diagnosis of advanced basal cell carcinoma (BCC), either metastatic or locally advanced BCC. Enrollment of patients with locally advanced BCC was limited to 80 of a planned total of 100 patients. Both cohorts received the same vismodegib 150 mg treatment.
Complete source fields
- 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
- FG000
- 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
- FG001
- title
- Locally Advanced Basal-Cell Carcinoma
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 16
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 3
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 2
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 7
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 23
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 2
- type
- Sponsor Decision to End the Study
- reasons
- group Id
- FG000
- num Subjects
- 18
- group Id
- FG001
- num Subjects
- 17
- type
- Disease Progression
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Reason Not Specified
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 33
- group Id
- FG001
- num Subjects
- 71
- comment
- All Enrolled Participants
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 33
- group Id
- FG001
- num Subjects
- 71
- comment
- Safety Population
- type
- Received at Least 1 Dose of Study Drug
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 33
- group Id
- FG001
- num Subjects
- 71
- type
- NOT COMPLETED
- title
- Overall Study
- recruitment Details
- The study population consisted of patients ≥ 18 years old with a histologically confirmed diagnosis of advanced basal cell carcinoma (BCC), either metastatic or locally advanced BCC. Enrollment of patients with locally advanced BCC was limited to 80 of a planned total of 100 patients. Both cohorts received the same vismodegib 150 mg treatment.
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Preserved source evidence · Not medical advice
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