COMPLETE AT DISCONTINUATION OF THERAPY / COMPLETE AT INITIATION OF THERAPY END OF STUDY BASELINE REPORTER INDICATION REPORTER CONTINUING REPORTER REPORTER MEDICATION / DOSE FREQUENCY ROUTE START STOP MED? INITIALS DATE AT END OF INITIALS DATE (If given for an AE, NON-MEDICATION (indicate DATE DATE enter the exact 1 Yes STUDY? units) – THERAPY term detailed on 2 No 1 Yes – – the AE form) 2 No – 1. 2. 3. 4. 5. 6. 7.
COMPLETE AT INITIATION OF THERAPY COMPLETE AT DISCONTINUATION OF THERAPY / END OF STUDY MEDICATION / NON-MEDICATION THERAPY INDICATION (If given for an AE, enter the exact term detailed on the AE form) BASELINE MED? 1 – Yes 2 – No DOSE (indicate units) FREQUENCY ROUTE START DATE REPORTER INITIALS REPORTER DATE STOP DATE CONTINUING AT END OF STUDY? 1 – Yes 2 – No REPORTER INITIALS REPORTER DATE 1. 2. 3. 4. 5. 6. 7.