Safety Rates Drug Report: adverse events in 2016 Q3 - FDA prescription drugs adverse events in an open, searchable, online, public database

Drug Injury Quarter

Person who experienced the adverse event (patient)

Event ID	CASEID	CASEVERSION	I F COD	EVENT DT	MFR DT	INIT FDA DT	FDA DT	REPT COD	AUTH NUM	MFR NUM	MFR SNDR	LIT REF	AGE	AGE COD	AGE GRP	GNDR COD	E SUB	WT	WT COD	REPT DT	TO MFR	OCCP COD	REPORTER COUNTRY	OCCR COUNTRY
113982793	11398279	3	F		20160923	20150820	20160928	EXP		MX-ROCHE-1621906	ROCHE		51.00	YR		F	Y	114.30000	KG	20160928		MD	MX	MX

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	DECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
113982793	11398279	1	PS	CAPECITABINE.	CAPECITABINE	1	Oral	LAST DOSE PRIOR TO SERIOUS EVENTS RECEIVED ON 03/AUG/2015. DISCONTINUED ON 04/AUG/2015	D	20896	1000	MG/M**2	TABLET	BID
113982793	11398279	2	SS	CISPLATIN.	CISPLATIN	1	Intravenous (not otherwise specified)	LAST DOSE PRIOR TO SERIOUS EVENTS ON 22/JUL/2015.	D	0	80	MG/M**2
113982793	11398279	3	C	DIPHENHYDRAMINE HYDROCHLORIDE.	DIPHENHYDRAMINE HYDROCHLORIDE	1	Unknown			0
113982793	11398279	4	C	RANITIDINE HYDROCHLORIDE.	RANITIDINE HYDROCHLORIDE	1	Unknown			0
113982793	11398279	5	C	APREPITANT.	APREPITANT	1	Unknown			0

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
113982793	11398279	1	Oesophageal adenocarcinoma
113982793	11398279	2	Oesophageal adenocarcinoma

Outcome of event

Reactions reported

Event ID	CASEID	PT
113982793	11398279	Multiple organ dysfunction syndrome
113982793	11398279	Neutropenia
113982793	11398279	Vomiting

Reporting Sources (this data is often not reported and may therefore be missing here)

no results found

no results found

Therapies reported

Event ID	CASEID	DSG DRUG SEQ	START DT	END DT
113982793	11398279	1	20150722	20150804
113982793	11398279	2	20150722
113982793	11398279	3	20150722	20150722
113982793	11398279	4	20150722	20150722
113982793	11398279	5	20150722	20150722