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

Reason Number of studies
Out of scope - ongoing related extension studies 1
Out of scope - Phase 1 study 106
Out of scope - Phase 4 study 7
Out of scope - study still ongoing 75
Out of scope - unapproved indication 15
Out of scope - risk of reidentification due to small number of patients 4
Out of scope - Could not identify study with information provided 11
Out of scope - Asset divested to another company 32
Data too old; not compatible with current anonymization applications 10
Novartis is not the sponsor of the requested study 24
Out of scope - cancelled studies 4
Out of scope - observational/expanded access studies 5
Novartis declined to share 2

+ 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