SUSPECT ADVERSE REACTION REPORT I REACTION INFORMATION 1 PATIENT

suspect adverse reaction report i. reaction information 1. patient initial 1a. country 2. date of birth

SUSPECT ADVERSE REACTION REPORT
I. REACTION INFORMATION
1. PATIENT INITIAL
1a.
COUNTRY
2. DATE OF BIRTH
2a. AGE
Years
3. SEX
4 - 6 REACTION ONSET
8 - 12 CHECK ALL APPROPRIATE TO ADVERSE REACTION
Day
Month
Year
Day
Month
Year
7 - 13 DESCRIBE REACTION (S) (including test/lab data)
Event :
Comment :
PATIENT DIED
INVOLVED OR PROLONGED INPATIENT HOSPITALISATION
INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY
LIFE THREATENING
II. SUSPECT DRUG(S) INFORMATION
14. SUSPECT DRUG(S) (including generic name)
20. DID REACTION ABATE AFTER STOPPING DRUG ?
YES NO NA
15. DAILY DOSE(S)
16. ROUTE(S) OF ADMINISTRATION
21. DID REACTION REAPPEAR AFTER REINTRODUCTION ?
17. INDICATION(S) FOR USE
YES NO NA
18. THERAPY DATES (from/to)
19. THERAPY DURATION
III. CONCOMITANT DRUG(S) AND HISTORY
22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those
used to treat reaction)
23. OTHER RELEVANT HISTORY (e;g; diagnostics, allergies, pregnancy
with last month of period, etc. ...)
IV. MANUFACTURER INFORMATION
24a. NAME AND ADDRESS OF MANUFACTURER
Subsidiary Reference Number
24b. MFR CONTROL N°
Other references
24c. DATE RECEIVED BY MANUFACTURER
24d. REPORT SOURCE
STUDY LITERATURE
 HEALTH PROFESSIONAL
DATE OF THIS REPORT
25a. REPORT TYPE
INITIAL FOLLOW-UP
Describe reaction (continuation) :
________________________________________________________________________________________________________________________
Formulário CIOMS / V01 1/1
Anexo ao PT-04