1. Unscheduled Visits and Epoch. User Cases

2. UC1: Complications Related to How to Slot Partial/Missing Dates (CV) Raw visit numberVISITNUMLBDYLBDTC 992014-03 99172014-03-17 Raw visit numberVISITNUMEGDYEGDTC 99missing VISITVISITNUMSVDYSVDTCSVUPDES Week 12132014-03-13 2014-03Lab Test ECG Test Week 1 Unscheduled172014-03-17Lab Test Week 23202014-03-20 LB EG SV

3. Raw visit numberVISITNUMLBDYLBDTC 99132014-03-13 99172014-03-17 Raw visit numberVISITNUMEGDYEGDTC 99172014-03-17 VISITVISITNUMSVDYSVDTCSVUPDES Week 12132014-03-13 Week 1 Unscheduled2.01132014-03-13Lab Test Week 1 Unscheduled2.02172014-03-17 Lab Test and ECG Test Week 23202014-03-20 UC2: Complications Related to Same Date (CV) LB EG SV Combined SVUPDES? Important to differentiate from same date planned visit?

4. UC3: Complications Related to Unscheduled performed instead scheduled (TK) Raw visit numberVISITNUMLBDYLBDTC 2missing 99172014-03-17 33282014-03-28 VISITVISITNUMSVDYSVDTCSVUPDES Week 12142014-03-14 Week 1 Unscheduled172014-03-17Lab Test Week 23282014-03-28 LB SV Planned lab measurement not performed at day 14, Instead of this measurement on day 17 is performed Is it still unschedul ed visit?

5. UC4: Example Partial Date Problem Assigning Epoch Using Dates (CV) ELEMENTEPOCHSESTDTCSEENDTC ScreenSCREENING2007-05-282007-05-29 Drug XOPEN LABEL TREATMENT2007-05-292007-06-10 Wash OutWASHOUT2007-06-102007-06-21 Drug ABLINDED TREATMENT2007-06-212007-06-28 Second Follow-upFOLLOW-UP2007-06-282007-07-03 SE CMSTDTCEPOCH 2007-05-28SCREENING 2007-05OPEN LABEL TREATMENT 2007-06-02FIRST TREATMENT 2007-06??? 2007-06-24SECOND TREATMENT 2007-07SECOND FOLLOW-UP CM Could have started during screening or open label treat. Choose treatment EPOCH Unknown. Could have started during open label treat, washout, blinded treat, or follow-up

6. UC5:Assigning of Epoch after treatment discontinuation (NS) Study epochs per protocol: ScreeningTreatmentFollow up Randomization Treatment start End of treatment, Date of last trt End of study, consent withdraw

7. UC5: (cont.) subject information CRF pages: end of treatment, FU, end of study Subject has got 2 cycles. Last TRTDTC=2014-02-01 Cycle 3 should start at 2014-02-21, but subject has AE, thus treatment delay, No bettering after 14 days, Lab visit, EG Visit performed. => Physician decision to discontinue treatment Subject comes to visit and decide not to go to FU, but to withdraw consent at 2014-03-14, so no FU observation and data collection, end of study. Q: Which epoch and VISITNUM to assign to LB and EG visit in delay period?

8. UC5(cont.) Subject time axis ScreeningTreatmentFollow up? Randomization Treatment start End of treatment, Date of last trt End of study, consent withdraw Last treatment 2014-02-01 Consent W. 2014-03-14 LB and EG visit No FU information collected in Original EDC DB