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
125216041	12521604	1	I		20160627	20160701	20160701	EXP		PHHY2016CN088849	NOVARTIS	DING B, ZHANG Q, SHI W, TAO H, HE Z, WANG C ET AL.. NILOTINIB FOR THE TREATMENT OF CHRONIC MYELOID LEUKEMIA WITH THE ONSET OF PLEURAL EFFUSION?2 CASES WITH LITERATURE REVIEW. CHINA MEDICAL HERALD. 2016;13(15):166-9	53.00	YR		F	Y	0.00000		20160701		OT	CN	CN

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
125216041	12521604	1	PS	TASIGNA	NILOTINIB	1	Unknown	400 MG, BID							22068	400	MG		BID
125216041	12521604	2	SS	HYDROXYCARBAMIDE	HYDROXYUREA	1	Unknown	UNK			U				0

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125216041	12521604	1	Blast crisis in myelogenous leukaemia
125216041	12521604	2	Blast crisis in myelogenous leukaemia

Outcome of event

Event ID	CASEID	OUTC COD
125216041	12521604	HO
125216041	12521604	DE

Reactions reported

Event ID	CASEID	PT
125216041	12521604	Anaemia
125216041	12521604	Bone marrow failure
125216041	12521604	Dizziness
125216041	12521604	Haemorrhage
125216041	12521604	Infection
125216041	12521604	Pyrexia

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
125216041	12521604	1	20150507		0