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
122294952	12229495	2	F	2016	20160711	20160401	20160715	EXP		CA-009507513-1603CAN011912	MERCK		57.01	YR		M	Y	0.00000		20160715		CN	CA	CA

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
122294952	12229495	1	PS	TEMODAL	TEMOZOLOMIDE	1	Oral	HIGHER DOSE, UNK	21029			CAPSULE
122294952	12229495	2	SS	TEMODAL	TEMOZOLOMIDE	1	Oral	100 MG, UNK	21029	100	MG	CAPSULE
122294952	12229495	3	SS	TEMODAL	TEMOZOLOMIDE	1	Oral	80 MG DAILY	21029	80	MG	CAPSULE	QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
122294952	12229495	1	Glioblastoma multiforme

Outcome of event

Reactions reported

Event ID	CASEID	PT
122294952	12229495	Blood test abnormal
122294952	12229495	Neoplasm recurrence
122294952	12229495	Post procedural complication
122294952	12229495	Surgery

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
122294952	12229495	1	201509	201601
122294952	12229495	2	201601	20160323
122294952	12229495	3	20160324	2016