Version: 1.0.0 | Published: 8 Oct 2024 | Updated: 269 days ago
Documentation
Description:
SLS Asthma - Primary Effectiveness Analysis (PEA) - This population is defined as all ITT subjects (all randomised subjects who receive at least one prescription of study medication [e.g. FF/VI or Usual Care]) who have an ACT total score of < 20 at baseline (Day 0).
This population will be based on the treatment to which the subject was randomised.
SLS COPD - Primary Effectiveness Analysis (PEA) - This population comprised all ITT subjects (all randomised subjects who received at least one prescription for study medication [e.g. FF/VI or usual care] who had at least one moderate/severe exacerbation in the year prior to Visit 2 (randomisation), as recorded on the eCRF.
Coverage
Spatial:
United Kingdom,England,North West,Salford; United Kingdom,England,North
West,Manchester
Typical Age Range:
18-91
Provenance
Origin
Purposes:
Study
Sources:
EPR
Collection Situations:
Other
Temporal
Accrual Periodicity:
Static
Distribution Release Date:
04 December 2016
Start Date:
13 March 2012
End Date:
04 December 2016
Time Lag:
Not applicable
Accessibility
Access
Access Rights:
Access Service:
Following receipt of a signed Data Sharing Agreement (DSA), Researchers are
provided access to anonymised patient-level data and supporting documentation in
a secure data access system, known as the SAS Clinical Trial Data Transparency
(CTDT) system.
Access Request Cost:
Delivery Lead Time:
Not applicable
Data Controller:
SHARE (GSK data sharing team)
Data Processor:
GSK Biostatistics (Respiratory)
Usage
Data Use Limitations:
General research use
Resource Creators:
GSK
Format and Standards
Vocabulary Encoding Schemes:
LOCAL
Languages:
en
Formats:
SAS Dataset (.sas7bdat)