Adverse Event Report Form and Guidelines For …

1 Adverse Event Report form and Guidelines For clinical studies The Adverse Event Report (AER) form is used to collect initial and follow-up information for serious Adverse events as well as Adverse Experiences of Special Interest (selected non-serious Adverse experiences or events of clinical interest (ECIs)) for patients participating in a Merck-sponsored study anywhere in the world. All serious Adverse events , AEs of Special Interest, and pregnancies are to be reported to the Sponsor (Merck & Co., Inc.) within 24 hours of when first learned by the site (initial and follow up reports).

2 Call the Sponsor to Report SAE (refer to protocol for contact names and numbers). Complete the clinical Study Adverse Event form and fax into the Sponsor within 1 business day. The following Guidelines explain how to complete the AER form . Ensure that all relevant medical information necessary to support the AE term(s) is provided. Please fax all 4 pages to PRA Global Medical and Safety A. General Information Services (GMSS) at 877-276-3444 or 913-3075750. Field Name Description Compound ID Enter the generic name of the test product, if one is known, otherwise state the MK#, V#.

3 Full Name of Primary Enter the full name of the primary investigator. Investigator Site # Enter only the site number designated to the site Initial Indicate whether the Report is the initial Report (first time SAE is reported), or if it is a follow up. Follow-Up Note: see section J for instructions on using the form to Report follow up information Date Reported to Merck Enter the date the information included in this Report was reported to Merck by the study site. By Study Site Protocol # Enter the protocol number assigned to the study (3 digit number + suffix).

4 The base protocol is indicated with the suffix -00.. Extensions and amendments are indicated in 2. additional digits ( , -01 for the first amendment, - 10 for the first extension, and -21 for the first amendment to the second extension). , 015-10 (protocol #15, extension #1. Person Reporting Event Enter the name of the individual from the study site who is reporting the Event . Page 1 of 14. 15-Apr-2009. Field Name Description Complete Study Title Enter the title of the study, as stated in protocol. Note: This field will auto-fill, when the form is completed on-line (based on the compound ID and protocol # entered above).)

5 B. Patient Information Field Name Description Allocation # Enter the allocation number of the patient (post- randomization). Baseline # Enter the baseline number assigned to the patient (only when a randomization number has not been assigned . pre-treatment period). Age Enter the patient's age at the time of the onset of the AE. Sex Enter Male or female. Weight Enter the weight of the subject at the time of study initiation and circle the unit type (Kg, Lb). Pregnant Circle Y if the patient was pregnant at the time of exposure to the study therapy.

6 Circle N if the patient was not pregnant at the time of exposure to the study therapy. Circle U if it is unknown whether or not the patient was pregnant at the time of exposure to study therapy. Note: If a patient becomes pregnant while on study therapy, treat this Event as an SAE and forward to Merck/WPS even if there are no AEs noted. Follow-up should be obtained on the outcome of the pregnancy. Weeks of Gestation Enter the number of weeks gestation at the time that the patient initiated study drug therapy. C. Adverse Event (s).

7 Field Name Description Adverse Event (s) List the verbatim Adverse Event term(s). Symptoms ( , fever, abdominal pain, etc.) may be all Page 2 of 14. 15-Apr-2009. Field Name Description that is available when the SAE is first reported. If this is the case, submit the initial Report with the signs and symptoms that met the serious criteria listed as AE. terms; update the form accordingly with the diagnosis, and submit as a follow up Report . When only the death of the subject is known (no cause or AE has been yet determined), enter the term death.

8 As the AE term. Once the cause is known, the correct AE term can then be listed. List all serious as well as non-serious AEs associated with the Event . A recurrence of the same AE, an AE. related to the originally reported Event , or a new serious Event occurring within 30 days of the original Event , should be reported as follow-up to the original Report . A new serious AE that occurs more than 30. days after the original Event and is unrelated clinically to the original Event should be reported as a new SAE. Report .

9 Note: Although an AE can result in hospitalization or lead to surgery or diagnostic testing, the hospitalization, surgery or diagnostic procedure is, in and of itself, not the AE. The Event , not the hospitalization or procedure, should be listed as the AE term. In addition, hospitalization for elective surgery for a preexisting condition which has not worsened while on therapy with study drug is not an AE. If the patient died, record probable cause(s) of death as AE(s) OR if the death is unknown, record death as the AE term.

10 Once the cause of death is known, replace the term death with the AE(s). that caused the death of the patient. AE Onset Date Enter the date of onset of the signs or symptoms related to the Adverse experience. Note: For hospitalization cases, the onset date of the SAE may be prior to the date of hospitalization. AE Stop Date Enter the date on which the subject/patient was determined to have completely recovered or recovered with sequelae from the reported Adverse Event Relationship to Study , Causality Drug Enter Y if the investigator considered that there was a Page 3 of 14.