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Metrics

Reasons why access cannot be provided (enquiries for Novartis studies)

Reason Number of studies
Out of scope - ongoing related extension studies 0
Out of scope - Phase 1 study 0
Out of scope – Phase 4 study 0
Out of scope - study still ongoing 28
Out of scope - unapproved indication 3
Out of scope - risk of reidentification due to small number of patients 1
Out of scope - Could not identify study with information provided 4
Out of scope - Asset divested to another company 7
Data too old; not compatible with current anonymization applications 0
Novartis is not the sponsor of the requested study 11
Out of scope - cancelled studies 4
Out of scope - observational/expanded access studies 5

+ The Research Proposal is not seeking access to anonymised patient level data

+ The Research Proposal did not meet the Sponsor policies for informed consent

+ The proposed research required data that was not collected in the studies requested

+ The Research Proposal competes with the Sponsor's publication plan