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
125595501	12559550	1	I	20140417	20140423	20160715	20160715	EXP		PHHO2014FR019340	NOVARTIS		42.80	YR		F	Y	38.00000	KG	20160715		MD	FR	FR

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	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
125595501	12559550	1	PS	DABRAFENIB	DABRAFENIB	1	Oral	150 MG, BID	3000	MG	Y	N	202806	150	MG	CAPSULE	BID
125595501	12559550	2	SS	DABRAFENIB	DABRAFENIB	1	Oral	150 MG, UNK	3000	MG	Y	N	202806	150	MG	CAPSULE
125595501	12559550	3	SS	DABRAFENIB	DABRAFENIB	1	Oral	200 MG, UNK	3000	MG	Y	N	202806	200	MG	CAPSULE
125595501	12559550	4	SS	PANITUMUMAB	PANITUMUMAB	1	Intravenous (not otherwise specified)	6 MG/KG, CYCLIC EVERY 2 WEEKS					0	6	MG/KG

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
125595501	12559550	1	Colorectal cancer
125595501	12559550	4	Colorectal cancer

Outcome of event

Event ID	CASEID	OUTC COD
125595501	12559550	HO
125595501	12559550	OT

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
125595501	12559550		Diarrhoea haemorrhagic
125595501	12559550		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
125595501	12559550	1	20140407	20140419
125595501	12559550	2	20150420	20150420
125595501	12559550	3	20140424
125595501	12559550	4	20140407