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
122969463	12296946	3	F	20160817	20160823	20160422	20160830	EXP		PHHY2016EC054660	NOVARTIS		81.13	YR		M	Y	0.00000		20160830		CN	COUNTRY NOT SPECIFIED	EC

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	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
122969463	12296946	1	PS	AFINITOR	EVEROLIMUS	1	Oral	10 MG, QD	3080	MG	22334	10	MG	TABLET	QD
122969463	12296946	2	SS	AFINITOR	EVEROLIMUS	1	Oral	10 MG, QD	3080	MG	22334	10	MG	TABLET	QD
122969463	12296946	3	SS	SANDOSTATIN LAR DEPOT	OCTREOTIDE ACETATE	1	Intramuscular	20 MG, QMO	240	MG	0	20	MG		/month

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
122969463	12296946	1	Neuroendocrine tumour
122969463	12296946	3	Neuroendocrine tumour

Outcome of event

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
122969463	12296946		Dyspnoea
122969463	12296946		Pulmonary oedema

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
122969463	12296946	1	20150910	20160407
122969463	12296946	2	20160507	20160811
122969463	12296946	3	20150911	20160811