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
123573115	12357311	5	F	20160427	20160804	20160511	20160808	EXP		DE-GILEAD-2016-0211301	GILEAD		77.00	YR	E	M	Y	75.00000	KG	20160808		MD	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	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
123573115	12357311	1	PS	IDELALISIB	IDELALISIB	1	Oral	300 MG, QD	23100	MG	205858	300	MG	TABLET	QD
123573115	12357311	2	SS	MABTHERA	RITUXIMAB	1	Unknown	100 MG-500 MG			0
123573115	12357311	3	SS	MABTHERA	RITUXIMAB	1	Unknown	100 MG-500 MG			0
123573115	12357311	4	SS	MABTHERA	RITUXIMAB	1	Unknown	100 MG-500 MG			0
123573115	12357311	5	C	CAPTOGAMMA		2		6.25			0

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
123573115	12357311	1	Chronic lymphocytic leukaemia
123573115	12357311	2	Chronic lymphocytic leukaemia
123573115	12357311	5	Hypertonia

Outcome of event

Reactions reported

Event ID	CASEID	PT
123573115	12357311	Cerebral infarction
123573115	12357311	Pneumonia
123573115	12357311	Sepsis

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
123573115	12357311	1	20160210	20160427
123573115	12357311	2	20160414	20160414
123573115	12357311	3	20160218	20160218
123573115	12357311	4	20160303	20160331
123573115	12357311	5	1989	20160427