NCT01327053 · MORE INFO

Limitations, agreements, and source contact

A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma · Source last updated 2019-08-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

certain Agreement

other Details: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
pi Sponsor Employee: false
restriction Type: OTHER
restrictive Agreement: true

limitations And Caveats

description: 230 patients evaluated in the Full Analysis Set: 79 randomized to LDE225 (Sonidegib) 200mg group \& 151 randomized to LDE225 800mg group. 1 patient randomized to the 800mg group did not receive study treatment \& thus was not counted in the Safety Set.

point Of Contact

Complete source fields

certain Agreement

other Details: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
pi Sponsor Employee: false
restriction Type: OTHER
restrictive Agreement: true

limitations And Caveats

description: 230 patients evaluated in the Full Analysis Set: 79 randomized to LDE225 (Sonidegib) 200mg group \& 151 randomized to LDE225 800mg group. 1 patient randomized to the 800mg group did not receive study treatment \& thus was not counted in the Safety Set.

point Of Contact

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Preserved source evidence · Not medical advice