cubeCDMS-BETA [ CUBEDEMO-2017 ]

I.REACTION INFORMATION

1.PATIENT INITIALS		1a.COUNTRY

2.DATE OF BIRTH		2a.AGE

3.SEX		4-6.REACTION ONSET

Audit Trail

::3.SEX::

Type	Audit	User	Time	Status	Reason
DATA	Male	sran	2019-11-26 22:44:04 (UTC-4)		INITIAL DATA

::4-6.REACTION ONSET::

Type	Audit	User	Time	Status	Reason
DATA		sran	2019-11-26 22:44:04 (UTC-4)		INITIAL DATA

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

REPORTED TERM	Common carotid artery perforation test test test test test test test test test test test test test test test test test test test test test test test test test test test test test test test test test

DURATION(Start Date)		DURATION(End Date)

SEVERITY	line1 line2 line3 line4 line5	OUTCOME	Not recovered/Not resolved

CAUSALITY	Not related (line 1)	ACTION TAKEN	Not applicable

CASE Narration

8-12 CHECK ALL APPROPRIATE TO ADVERSE REACTION	PATIENT DIED INVOLVED OR PROLONGED INPATIENT HOSPITALIZATION INVOLVED PERSISTENCE OF SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING OTHER

II.SUSPECT DRUG(S) INFORMATION

No	14. SUSPECT DRUG(S) (include generic name)	15. DAILY DOSE(S)	16. ROUTE(S) OF ADMINISTRATION	17. INDICATION(S) FOR USE	18. THERAPY DATES(Start date)	18. THERAPY DATES(End date)	19. THERAPY DURATION

20. DID REACTION ABATE AFTER STOPPING DRUG?	YES NO NA

21. DID REACTION REAPPEAR AFTER REINTRODUCTION?	YES NO NA

III.CONCOMITANT DRUG(S) AND HISTORY

22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction)

No	Drug Name (Generic Name)	Dose	Unit	Route	Start date	Ongoing	Stop date	Indication

23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergies, pregnancy with last month of period. etc.)

No	Diagnosis/Allergy/Surgery	Date of Diagnosis/Allergy/Surgery	End Date	Status

IV. MANUFACTURER INFORMATION

24a. NAME AND ADDRESS OF MANUFACTURER	a	24b. MFR. CONTROL NO.

24c. DATE RECEIVED BY MFR		24d. REPORT SOURCE	STUDY LITERATURE HEALTH PROFESSIONAL

DATE OF THIS REPORT		25a. REPORT TYPE	INITIAL FOLLOWUP

25b. NAME AND ADDRESS OF REPORTER