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
126174491	12617449	1	I		20160331	20160803	20160803	EXP		DE-BRISTOL-MYERS SQUIBB COMPANY-BMS-2016-024921	BRISTOL MYERS SQUIBB		61.00	YR		M	Y	110.00000	KG	20160803		CN	DE	DE

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	CUM DOSE CHR	CUM DOSE UNIT	DECHAL	RECHAL	LOT NUM	EXP DT	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
126174491	12617449	1	PS	SPRYCEL	DASATINIB	1	Oral	UNK			N				21986			FILM-COATED TABLET

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
126174491	12617449	1	Chronic myeloid leukaemia

Outcome of event

Event ID	CASEID	OUTC COD
126174491	12617449	OT
126174491	12617449	HO

Reactions reported

Event ID	CASEID	PT
126174491	12617449	Ascites
126174491	12617449	Aspiration pleural cavity
126174491	12617449	Dyspnoea
126174491	12617449	General physical health deterioration
126174491	12617449	Generalised oedema
126174491	12617449	Pericardial effusion
126174491	12617449	Peritonitis bacterial
126174491	12617449	Pleural effusion
126174491	12617449	Pulmonary hypertension

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	DUR	DUR COD
126174491	12617449	1	201407		0