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
116055002	11605500	2	F	20141016	20160913	20151007	20160923	EXP		US-BAXTER-2015BAX053267	BAXTER		17.00	YR		M	Y	62.00000	KG	20160922		MD	US	US

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	DECHAL	LOT NUM	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
116055002	11605500	1	PS	CYCLOPHOSPHAMIDE FOR INJECTION, USP	CYCLOPHOSPHAMIDE	1	Intravenous (not otherwise specified)	PROPHASE (CYCLES=5DAYS), OVER 15-30 MINUTES, ON DAY 1 AND 2			40745	200	MG/M**2	POWDER FOR SOLUTION FOR INJECTION
116055002	11605500	2	SS	CYCLOPHOSPHAMIDE FOR INJECTION, USP	CYCLOPHOSPHAMIDE	1	Intravenous (not otherwise specified)	COURSE B (CYCLES=21DAYS), CYCLES 2, 4 AND 6, OVER 15-30 MINS ON DAYS 1-5			40745	200	MG/M**2	POWDER FOR SOLUTION FOR INJECTION
116055002	11605500	3	SS	IFOSFAMIDE FOR INJECTION	IFOSFAMIDE	1	Intravenous (not otherwise specified)	COURSE A (CYCLE=21DAYS), CYCLE 1 AND 3, OVER 60 MINS ON DAYS 1-5			19763	800	MG/M**2	POWDER FOR SOLUTION FOR INFUSION
116055002	11605500	4	SS	IFOSFAMIDE FOR INJECTION	IFOSFAMIDE	1	Intravenous (not otherwise specified)	COURSE A (CYCLES=21DAYS), CYCLE 5, OVER 60 MINS ON DAYS 1-5			19763	800	MG/M**2	POWDER FOR SOLUTION FOR INFUSION
116055002	11605500	5	SS	CRIZOTINIB	CRIZOTINIB	1	Oral	COURSE A (CYCLES=21 DAYS): CYCLES 1 AND 3, ON DAYS 1-21			0	165	MG/M**2		BID
116055002	11605500	6	SS	CRIZOTINIB	CRIZOTINIB	1	Oral	COURSE B (CYCLES=21DAYS), CYCLES 2, 4 AND 6, ON DAYS 1-21			0	165	MG/M**2		BID
116055002	11605500	7	SS	CRIZOTINIB	CRIZOTINIB	1	Oral	COURSE A (CYCLES=21 DAYS): CYCLES 5, ON DAYS 1-21			0	165	MG/M**2		BID
116055002	11605500	8	SS	CYTARABINE.	CYTARABINE	1	Intrathecal	PROPHASE (CYCLES=5DAYS), 15-24 MG, ON DAY 1, AGE BASED DOSING		072168	0
116055002	11605500	9	SS	CYTARABINE.	CYTARABINE	1	Intravenous (not otherwise specified)	COURSE A (CYCLE=21DAYS): CYCLE 1, 3, OVER 1-30 MINS EVERY 12 HOURS ON DAYS 4, 5		072168	0	150	MG/M**2		Q12H
116055002	11605500	10	SS	CYTARABINE.	CYTARABINE	1	Intravenous (not otherwise specified)	COURSE A (CYCLES=21DAYS), CYCLE 5, DAY 4, OVER 1-30 MINS		072168	0	150	MG/M**2		Q12H
116055002	11605500	11	SS	HYDROCORTISONE.	HYDROCORTISONE	1	Intrathecal	PROPHASE (CYCLES=5DAYS), 7.5-12 MG, ON DAY 1, AGE BASED DOSING	D		0
116055002	11605500	12	SS	VP-16	ETOPOSIDE	1	Intravenous (not otherwise specified)	COURSE A (CYCLES=21DAYS), CYCLE 1, 3 OVER 2 HOURS ON DAYS 4, 5			0	100	MG/M**2
116055002	11605500	13	SS	VP-16	ETOPOSIDE	1	Intravenous (not otherwise specified)	COURSE A (CYCLES=21DAYS), CYCLE 5 OVER 2 HOURS ON DAYS 4			0	100	MG/M**2
116055002	11605500	14	SS	METHOTREXATE.	METHOTREXATE	1	Intrathecal	PROPHASE (CYCLE=5 DAYS), 7.5-12 MG, ON DAY 1, AGE BASED DOSING			0
116055002	11605500	15	SS	METHOTREXATE.	METHOTREXATE	1	Intravenous (not otherwise specified)	COURSE A (CYCLES=21DAYS), CYCLE 1 AND 3, OVER 3 HOURS ON DAY1			0	3000	MG/M**2
116055002	11605500	16	SS	METHOTREXATE.	METHOTREXATE	1	Intravenous (not otherwise specified)	COURSE B (CYCLES=21DAYS), CYCLE 2, 4 AND 6, OVER 3 HOURS ON DAY1			0	3000	MG/M**2
116055002	11605500	17	SS	METHOTREXATE.	METHOTREXATE	1	Intravenous (not otherwise specified)	COURSE A (CYCLES=21DAYS), CYCLE 5, OVER 3 HOURS ON DAY1			0	3000	MG/M**2
116055002	11605500	18	SS	DEXAMETHASONE.	DEXAMETHASONE	1	Oral	PROPHASE (CYCLE=5 DAYS), ON DAYS 1 AND 2			0	5	MG/M**2		QD
116055002	11605500	19	SS	DEXAMETHASONE.	DEXAMETHASONE	1	Oral	PROPHASE (CYCLE=5 DAYS), ON DAYS 3 AND 5			0	5	MG/M**2		BID
116055002	11605500	20	SS	DEXAMETHASONE.	DEXAMETHASONE	1	Oral	COURSE A (CYCLES=21DAYS), CYCLE 1 AND 3, ON DAYS 1-5			0	5	MG/M**2		BID
116055002	11605500	21	SS	DEXAMETHASONE.	DEXAMETHASONE	1	Oral	COURSE B (CYCLES=21 DAYS), CYCLE 2, 4 AND 6, ON DAYS 1-5			0	5	MG/M**2		BID
116055002	11605500	22	SS	DEXAMETHASONE.	DEXAMETHASONE	1	Oral	COURSE A (CYCLES=21DAYS), CYCLE 5, ON DAYS 1-5			0	5	MG/M**2		BID
116055002	11605500	23	SS	NEULASTA	PEGFILGRASTIM	1	Unknown		U		0
116055002	11605500	24	SS	DOXORUBICIN HYDROCHLORIDE.	DOXORUBICIN HYDROCHLORIDE	1	Intravenous (not otherwise specified)	COURSE B (CYCLES=21DAYS), CYCLE 2, 4 AND 6, OVER 1-15 MINS ON DAYS 4, 5			0	25	MG/M**2

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
116055002	11605500	1	Anaplastic large cell lymphoma T- and null-cell types
116055002	11605500	3	Anaplastic large cell lymphoma T- and null-cell types
116055002	11605500	5	Anaplastic large cell lymphoma T- and null-cell types
116055002	11605500	8	Anaplastic large cell lymphoma T- and null-cell types
116055002	11605500	11	Anaplastic large cell lymphoma T- and null-cell types
116055002	11605500	12	Anaplastic large cell lymphoma T- and null-cell types
116055002	11605500	14	Anaplastic large cell lymphoma T- and null-cell types
116055002	11605500	18	Anaplastic large cell lymphoma T- and null-cell types
116055002	11605500	23	Product used for unknown indication
116055002	11605500	24	Anaplastic large cell lymphoma T- and null-cell types

Outcome of event

Event ID	CASEID	OUTC COD
116055002	11605500	OT
116055002	11605500	HO

Reactions reported

Event ID	CASEID	DRUG REC ACT	PT
116055002	11605500		Back pain
116055002	11605500		Hypertension

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
116055002	11605500	1	20140708
116055002	11605500	4	20141013
116055002	11605500	7	20141013
116055002	11605500	8	20140708
116055002	11605500	10	20141016
116055002	11605500	11	20140708	20140708
116055002	11605500	13	20141016
116055002	11605500	14	20140708
116055002	11605500	17	20141013
116055002	11605500	18	20140708
116055002	11605500	22	20141013