RELY-ABLE 23 MONTH FOLLOW-UP CRF 6-03

PART B. OTHER INFORMATION

Questions 2a) and 2b): Indicate the range of report numbers completed since the last visit, up to and including this
visit. If only one report was completed enter the report number in the first set of boxes.
Question 2a): If the patient experienced a non-serious Adverse Event resulting in discontinuation of study medication,
complete an Adverse Event report. When the event becomes resolved, go back to the original Adverse Event CRF and
update the details on the CRF.
Question 2b): If the patient experienced a Serious Adverse Event complete the SAE Report. Please refer to the RELY-
ABLE SAE Reporting Algorithm and List of Exempted Events for further details.
Question 2c): Hospitalizations: If the patient was admitted to hospital (for more than 23 hours) since the last visit, up
to and including this visit, provide details at Admission #1. If the patient had more than one admission to hospital (>23
hours), provide details for the first three admissions. Maintain details for all hospitalizations in patient file. You may be
asked to provide information at a future date.
Primary Reason for Hospitalization - For each admission to hospital, provide the code for primary reason for admis-
sion”
01 Outcome Event
02 New angina
03 Atrial fib/flutter
04 Non fatal cardiac arrest
05 Supraventricular arrhythmia
06 Ventricular arrhythmia
07 Valve surgery
08 CABG surgery
09 PTCA surgery
10 Carotid endarterectomy
11 Peripheral angioplasty/surgery
12 Limb amputation
13 Cancer
14 Injury (eg. fall)
15 Fracture
16 Psychiatric
17 Hematologic
18 Genito-urinary
19 Gastrointestinal
20 Diabetic complications
21 Other Non-cardiac
22 Other Cardiac reason not listed

PART C. STUDY MEDICATION:

This section is to record tempoary interruptions and/or re-starts of study medication. If the patient permanently
stops study medication, instead of completing the usual follow-up visit, complete the 28 Month Follow-up /
Early Termination Visit CRFs 7-01 to 7-05.
Question 1. If since the last visit, up to and including this visit, there was no interruption in use of study drug or no re-
start of study drug from a previously reported interruption, respond NO and proceed to Question 2.
If there was a temporary interruption of study drug, OR a re-start of study drug since the last visit, up to and including
this visit, respond YES and complete all applicaple details (Questions 1a-1d).

Codes for reason for temporary interruption or permanent stop: (select the MAIN reason)
01 - Serious Adverse Event
02 - Elevated LFT Result
03 - Outcome Event
04 - Hospitalization
05 - Surgery
06 - Non-serious Adverse Event resulting in discontinuation of study drug
07 - Reduced Creatinine Clearance
08 - Patient refused to continue taking study medication
99 - Other (specify)

23 MONTH FOLLOW-UP CRF 6-03 Version 2008Nov27