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
113158766	11315876	6	F	20150615	20160722	20150728	20160728	EXP		JP-BRISTOL-MYERS SQUIBB COMPANY-BMS-2015-046728	BRISTOL MYERS SQUIBB		70.00	YR		F	Y	0.00000		20160728		CN	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	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
113158766	11315876	1	PS	NIVOLUMAB	NIVOLUMAB	1	Intravenous drip	2 MG/KG, Q3WK	2	MG/KG	Y	125554	2	MG/KG	SOLUTION FOR INJECTION	Q3W
113158766	11315876	2	SS	NIVOLUMAB	NIVOLUMAB	1	Intravenous drip	2 MG/KG, UNK	2	MG/KG	Y	125554	2	MG/KG	SOLUTION FOR INJECTION
113158766	11315876	3	SS	NIVOLUMAB	NIVOLUMAB	1	Intravenous drip	2 MG/KG, UNK	2	MG/KG	Y	125554	2	MG/KG	SOLUTION FOR INJECTION
113158766	11315876	4	SS	NIVOLUMAB	NIVOLUMAB	1	Intravenous drip	2 MG/KG, UNK	2	MG/KG	Y	125554	2	MG/KG	SOLUTION FOR INJECTION
113158766	11315876	5	SS	NIVOLUMAB	NIVOLUMAB	1	Intravenous drip	2 MG/KG, UNK	2	MG/KG	Y	125554	2	MG/KG	SOLUTION FOR INJECTION
113158766	11315876	6	SS	NIVOLUMAB	NIVOLUMAB	1	Intravenous drip	2 MG/KG, UNK	2	MG/KG	Y	125554	2	MG/KG	SOLUTION FOR INJECTION
113158766	11315876	7	SS	AZULFIDINE	SULFASALAZINE	1	Oral	500 MG, BID			U	0	500	MG		BID

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
113158766	11315876	1	Malignant melanoma
113158766	11315876	7	Rheumatoid arthritis

Outcome of event

Event ID	CASEID	OUTC COD
113158766	11315876	HO
113158766	11315876	OT

Reactions reported

Event ID	CASEID	PT
113158766	11315876	Herpes zoster
113158766	11315876	Inappropriate schedule of drug administration
113158766	11315876	Musculoskeletal pain

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
113158766	11315876	1	20150610	20150610
113158766	11315876	2	20150701	20150701
113158766	11315876	3	20150803	20150803
113158766	11315876	4	20151109	20151109
113158766	11315876	5	20151207	20151207
113158766	11315876	6	20160113	20160113
113158766	11315876	7	200705