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
125719781	12571978	1	I	20160412	20160419	20160719	20160719	EXP		JP-SA-2016SA080983	AVENTIS		33.00	YR	A		Y	55.40000	KG	20160719		PH	JP	JP

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DECHAL	LOT NUM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FREQ
125719781	12571978	1	PS	DOCETAXEL.	DOCETAXEL	1	Intravenous drip	N	UNKNOWN	20449	85	MG	Q3W
125719781	12571978	2	SS	GEMCITABINE	GEMCITABINEGEMCITABINE HYDROCHLORIDE	1	Intravenous drip	N	UNKNOWN	0	1100	MG	Q3W
125719781	12571978	3	C	GRANISETRON	GRANISETRON	1	Intravenous drip			0	3	MG	Q3W

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125719781	12571978	3	Vomiting

Outcome of event

Event ID	CASEID	OUTC COD
125719781	12571978	HO
125719781	12571978	DE

Reactions reported

Event ID	CASEID	PT
125719781	12571978	Generalised oedema
125719781	12571978	Hypoproteinaemia
125719781	12571978	Leukaemoid reaction
125719781	12571978	Malaise
125719781	12571978	Peripheral nerve sheath tumour malignant
125719781	12571978	Pleural effusion
125719781	12571978	Respiratory failure

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
125719781	12571978	1	20150528	20160405
125719781	12571978	2	20150430	20160405
125719781	12571978	3	20150430	20160405