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
95218007	9521800	7	F	20121126	20160630	20130913	20160706	EXP		PHHY2013JP036083	NOVARTIS		68.04	YR		M	Y	58.00000	KG	20160706			JP	JP

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
95218007	9521800	1	PS	AFINITOR	EVEROLIMUS	1	Oral	10 MG, QD							22334	10	MG	TABLET	QD
95218007	9521800	2	SS	AFINITOR	EVEROLIMUS	1	Oral	5 MG, QD							22334	5	MG	TABLET	QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
95218007	9521800	1	Pancreatic neuroendocrine tumour

Outcome of event

Reactions reported

Event ID	CASEID	PT
95218007	9521800	Ascites
95218007	9521800	C-reactive protein increased
95218007	9521800	Cough
95218007	9521800	Death
95218007	9521800	Dyspnoea
95218007	9521800	Haemoglobin decreased
95218007	9521800	Interstitial lung disease
95218007	9521800	Malnutrition
95218007	9521800	Metastases to bone
95218007	9521800	Neoplasm progression
95218007	9521800	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
95218007	9521800	1	20121101	20121125	0
95218007	9521800	2	20130107	20130530	0