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
119721355	11972135	5	F	20131127	20160928	20160128	20160930	EXP		PHHY2016DE008731	NOVARTIS		0.00		E	F	Y	76.00000	KG	20160930		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	DECHAL	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FREQ
119721355	11972135	1	PS	AFINITOR	EVEROLIMUS	1	Unknown	10 MG, QD	405.65002	MG	D	22334	10	MG	QD
119721355	11972135	2	SS	AFINITOR	EVEROLIMUS	1	Unknown	10 MG, QD	405.65002	MG	D	22334	10	MG	QD
119721355	11972135	3	SS	AFINITOR	EVEROLIMUS	1	Unknown	5 MG, QD	405.65002	MG	D	22334	5	MG	QD
119721355	11972135	4	SS	AFINITOR	EVEROLIMUS	1	Unknown	5 MG, QD	405.65002	MG	D	22334	5	MG	QD
119721355	11972135	5	SS	XGEVA	DENOSUMAB	1	Subcutaneous	120 MG, QMO			D	0	120	MG	/month
119721355	11972135	6	SS	XGEVA	DENOSUMAB	1	Subcutaneous	120 MG, UNK			D	0	120	MG
119721355	11972135	7	SS	XGEVA	DENOSUMAB	1	Subcutaneous	120 MG, UNK			D	0	120	MG
119721355	11972135	8	SS	XGEVA	DENOSUMAB	1	Subcutaneous	120 MG, UNK			D	0	120	MG
119721355	11972135	9	SS	XGEVA	DENOSUMAB	1	Subcutaneous	120 MG, QMO			D	0	120	MG	/month
119721355	11972135	10	SS	XGEVA	DENOSUMAB	1	Subcutaneous	120 MG, UNK			D	0	120	MG
119721355	11972135	11	C	EXEMESTAN	EXEMESTANE	1	Oral	25 MG, QD			D	0	25	MG	QD
119721355	11972135	12	C	METOBETA		2	Oral	50 MG, QD			D	0	50	MG	QD
119721355	11972135	13	C	METOBETA		2	Oral	100 MG, QD			D	0	100	MG	QD
119721355	11972135	14	C	RAMIPRIL.	RAMIPRIL	1	Oral	5 MG, QD			D	0	5	MG	QD
119721355	11972135	15	C	VOLTAREN	DICLOFENAC SODIUM	1	Unknown	UNK UNK, QD			D	0			QD
119721355	11972135	16	C	PANTOZOL	PANTOPRAZOLE SODIUM	1	Oral	40 MG, QD			D	0	40	MG	QD
119721355	11972135	17	C	FOLICOMBIN		2	Unknown	UNK UNK, QD			D	0			QD
119721355	11972135	18	C	METFORMIN	METFORMIN HYDROCHLORIDE	1	Oral	ACCORDING TO BLOOD SUGAR, QD			D	0			QD
119721355	11972135	19	C	DUROGESIC	FENTANYL	1	Oral	100 UG EVERY THREE DAYS			D	0	100	UG

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
119721355	11972135	1	Breast cancer metastatic
119721355	11972135	5	Metastases to bone
119721355	11972135	6	Malignant neoplasm progression
119721355	11972135	7	Breast cancer
119721355	11972135	11	Breast cancer
119721355	11972135	12	Hypertension
119721355	11972135	14	Hypertension
119721355	11972135	15	Product used for unknown indication
119721355	11972135	16	Product used for unknown indication
119721355	11972135	17	Product used for unknown indication
119721355	11972135	18	Diabetes mellitus
119721355	11972135	19	Product used for unknown indication

Outcome of event

Reactions reported

Event ID	CASEID	PT
119721355	11972135	Malignant neoplasm progression
119721355	11972135	Metastases to bone
119721355	11972135	Osteonecrosis of jaw

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
119721355	11972135	1	20130903	20130912
119721355	11972135	2	20130919	20130920
119721355	11972135	3	20131002	20131223
119721355	11972135	4	20140107	20140730
119721355	11972135	5	20110706
119721355	11972135	6	20120913	201211
119721355	11972135	7	201212	201307
119721355	11972135	8	20130903
119721355	11972135	9	20131002
119721355	11972135	10	20131104
119721355	11972135	11	20130903	20140730
119721355	11972135	12	201307
119721355	11972135	14	201307
119721355	11972135	15	201307
119721355	11972135	16	201307
119721355	11972135	17	201307
119721355	11972135	18	201307
119721355	11972135	19	20110721