TriangleNCT02548845 · MORE INFO
Limitations, agreements, and source contact
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- certain Agreement
- other Details
- As a multicentre study, the first publication shall be based on consolidated analysed data from all centres, i.e. the publication of results from individual institution/Investigator is not allowed before the publication of the full study results. The PI agrees to give the sponsor 60 days to review the communications. If case of propietary information inadvertenly divulged, intellectual property rights at risk or inaccurate information presented, changes can be required by the sponsor.
- pi Sponsor Employee
- false
- restriction Type
- OTHER
- restrictive Agreement
- true
- limitations And Caveats
- description
- Recruitment problems leading to smaller sample size than expected (70 patients vs 100). A priori, the impact on precision was considered acceptable (95% confidence interval equal to ± 10.0% with 100 patients vs ± 11.7% with 70 patients).
- point Of Contact
- organization
- Otsuka Pharmaceutical Europe Ltd.
- phone
- +44(0)2037475000
- title
- Medical Department
Complete source fields
- certain Agreement
- other Details
- As a multicentre study, the first publication shall be based on consolidated analysed data from all centres, i.e. the publication of results from individual institution/Investigator is not allowed before the publication of the full study results. The PI agrees to give the sponsor 60 days to review the communications. If case of propietary information inadvertenly divulged, intellectual property rights at risk or inaccurate information presented, changes can be required by the sponsor.
- pi Sponsor Employee
- false
- restriction Type
- OTHER
- restrictive Agreement
- true
- limitations And Caveats
- description
- Recruitment problems leading to smaller sample size than expected (70 patients vs 100). A priori, the impact on precision was considered acceptable (95% confidence interval equal to ± 10.0% with 100 patients vs ± 11.7% with 70 patients).
- point Of Contact
- organization
- Otsuka Pharmaceutical Europe Ltd.
- phone
- +44(0)2037475000
- title
- Medical Department
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice