Fiche CIOMS/ CIOMS form

Fiche CIOMS/ CIOMS form

1

page

English

Documents

2001

Écrit par
Mcharpen

Publié par
ansm-drugs

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Le téléchargement nécessite un accès à la bibliothèque YouScribe Tout savoir sur nos offres

1

page

English

Documents

2001

Lire

Lire

Le téléchargement nécessite un accès à la bibliothèque YouScribe Tout savoir sur nos offres

Publié par

Publié le

29 août 2001

Nombre de lectures

148

Licence :

Langue

English

Drugs
29/08/2001

Publié par

Publié le

29 août 2001

Licence :

Langue

English

PATIENT DIED

INVOLVED OR PROLONGED INPATIENT HOSPITALISATION

INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY

III. CONCOMITANT DRUG(S) AND HISTORY

18. THERAPY DATES (from/to)

17. INDICATION(S) FOR USE

15. DAILY DOSE(S)

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. ...)

24c. DATE RECEIVED BY MANUFACTURER

DATE OF THIS REPORT

24d. REPORT SOURCE STUDY LITERATURE HEALTH PROFESSIONAL

25a. REPORT TYPE

INITIAL FOLLOW-UP

Describe reaction (continuation) :

Year

Day

Month

Day Month

Year

I. REACTION INFORMATION

8 - 12 CHECK ALL APPROPRIATE TO ADVERSE REACTION

3. SEX

4 - 6 REACTION ONSET

2. DATE OF BIRTH

2a. AGE Years

1. PATIENT INITIAL

1a. COUNTRY

SUSPECT ADVERSE REACTION REPORT

CIOMS FORM*

Event :

14. SUSPECT DRUG(S) (including generic name)

19. THERAPY DURATION

7 - 13 DESCRIBE REACTION (S) (including test/lab data)

Comment :

Subsidiary Reference Number

24b. MFR CONTROL N°

24a. NAME AND ADDRESS OF MANUFACTURER

IV. MANUFACTURER INFORMATION

YES NO NA

16. ROUTE(S) OF ADMINISTRATION

II. SUSPECT DRUG(S) INFORMATION

Other references

LIFE THREATENING

20. DID REACTION ABATE AFTER STOPPING DRUG ?

YES NO NA

21. DID REACTION REAPPEAR AFTER REINTRODUCTION ?