FORWARD SAP V2 0 2018-03-16 Final signedFORWARD_SAP_V2_0_2018-03-16_Final signed Author mollim...
Transcript of FORWARD SAP V2 0 2018-03-16 Final signedFORWARD_SAP_V2_0_2018-03-16_Final signed Author mollim...
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2.1 Primary objective .......................................................................................................................................... 8
2.2 Secondary objective ...................................................................................................................................... 8
2.3 Study design.................................................................................................................................................. 9
2.4 Planned sample size .................................................................................................................................... 11
3.1 Background details ..................................................................................................................................... 12
3.2 Deviations from the trial protocol with regard to statistical analyses ......................................................... 12
3.3 Individual protocol deviations .................................................................................................................... 12
4.1 Safety population ........................................................................................................................................ 13
4.2 Full analysis set population ......................................................................................................................... 13
4.3 Per-protocol population .............................................................................................................................. 13
4.4 Subgroup analyses ...................................................................................................................................... 13
5.1 Conventions ................................................................................................................................................ 14
5.1.1 Baseline definition ........................................................................................................................... 14
5.1.2 Missing data ..................................................................................................................................... 14
5.1.3 Pooling of centers ............................................................................................................................. 15
5.2 Demographic and other background data ................................................................................................... 15
5.2.1 Basic description .............................................................................................................................. 15
5.3 IMP exposure, compliance ......................................................................................................................... 16
5.4 Medical history, physical examination ....................................................................................................... 16
5.5 Prior and concomitant medication .............................................................................................................. 16
5.6 Concomitant non-pharmacological measures, pre-medication ................................................................... 16
5.7 Efficacy ....................................................................................................................................................... 17
5.7.1 Primary endpoint .............................................................................................................................. 17
5.7.2 Secondary endpoints ........................................................................................................................ 18
5.8 Pharmacokinetics / Pharmacodynamics ...................................................................................................... 19
5.9 Safety .......................................................................................................................................................... 19
5.9.1 Adverse events ................................................................................................................................. 19
5.9.2 Vital signs ........................................................................................................................................ 20
5.9.3 Safety laboratory variables ............................................................................................................... 20
5.10Other variables ............................................................................................................................................ 20
5.11Interim analyses .......................................................................................................................................... 21
8.1 Formulas for derived variables ................................................................................................................... 22
8.2 List of Tables, Listings, Figures ................................................................................................................. 22
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Quality Control
sICAM
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NOTES: * screening period lasts up to 7 days but can be extended to max 30 days in case of re-testing of sUA. sUA can be
re-tested if current sUA level is changed due to acute (transient) condition as it is not in line previous medical data as per
investigator opinion and approval from the Sponsor.
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