The Safety Rates Drug Report

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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
124204812 12420481 2 F 20130527 20160909 20160531 20160915 EXP PHHY2014JP050258 NOVARTIS 50.89 YR M Y 75.00000 KG 20160915 MD 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 RECHAL LOT NUM EXP DT NDA NUM DOSE AMT DOSE UNIT DOSE FORM DOSE FREQ
124204812 12420481 1 PS CERTICAN EVEROLIMUS 1 Oral 1.5 MG, QD 50 MG Y 21560 1.5 MG TABLET QD
124204812 12420481 2 SS CERTICAN EVEROLIMUS 1 Oral 1.25 MG, QD 50 MG Y 21560 1.25 MG TABLET QD
124204812 12420481 3 SS CERTICAN EVEROLIMUS 1 Oral 1 MG, QD 50 MG Y 21560 1 MG TABLET QD
124204812 12420481 4 SS CERTICAN EVEROLIMUS 1 Oral 0.75 MG, QD 50 MG Y 21560 .75 MG TABLET QD
124204812 12420481 5 SS CERTICAN EVEROLIMUS 1 Oral 0.5 MG, QD 50 MG Y 21560 .5 MG TABLET QD
124204812 12420481 6 SS CERTICAN EVEROLIMUS 1 Oral 0.75 MG, QD 50 MG Y 21560 .75 MG TABLET QD
124204812 12420481 7 SS CERTICAN EVEROLIMUS 1 Oral 0.5 MG, QD 50 MG Y 21560 .5 MG TABLET QD
124204812 12420481 8 C PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Oral 5 MG, UNK 0 5 MG
124204812 12420481 9 C PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Oral 2.5 MG, UNK 0 2.5 MG
124204812 12420481 10 C PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Oral 5 MG, UNK 0 5 MG
124204812 12420481 11 C PROGRAF TACROLIMUSTACROLIMUS ANHYDROUS 1 Oral 3.2 MG, UNK 0 3.2 MG
124204812 12420481 12 C PROGRAF TACROLIMUSTACROLIMUS ANHYDROUS 1 Oral 3.0 MG, UNK 0 3 MG
124204812 12420481 13 C PROGRAF TACROLIMUSTACROLIMUS ANHYDROUS 1 Oral 2.4 MG, UNK 0 2.4 MG
124204812 12420481 14 C PROGRAF TACROLIMUSTACROLIMUS ANHYDROUS 1 Oral 2.2 MG, UNK 0 2.2 MG
124204812 12420481 15 C PROGRAF TACROLIMUSTACROLIMUS ANHYDROUS 1 Oral 2.0 MG, UNK 0 2 MG
124204812 12420481 16 C PROGRAF TACROLIMUSTACROLIMUS ANHYDROUS 1 Oral 1.8 MG, UNK 0 1.8 MG
124204812 12420481 17 C PROGRAF TACROLIMUSTACROLIMUS ANHYDROUS 1 Oral 1.3 MG, UNK 0 1.3 MG
124204812 12420481 18 C PROGRAF TACROLIMUSTACROLIMUS ANHYDROUS 1 Oral 1.4 MG, UNK 0 1.4 MG
124204812 12420481 19 C PROGRAF TACROLIMUSTACROLIMUS ANHYDROUS 1 Oral 1.2 MG, UNK 0 1.2 MG
124204812 12420481 20 C PROGRAF TACROLIMUSTACROLIMUS ANHYDROUS 1 Oral 1.4 MG, UNK 0 1.4 MG
124204812 12420481 21 C PROGRAF TACROLIMUSTACROLIMUS ANHYDROUS 1 Oral 1.8 MG, UNK 0 1.8 MG
124204812 12420481 22 C PROGRAF TACROLIMUSTACROLIMUS ANHYDROUS 1 Oral 2 MG, UNK 0 2 MG
124204812 12420481 23 C PROGRAF TACROLIMUSTACROLIMUS ANHYDROUS 1 Oral 2.2 MG, UNK 0 2.2 MG
124204812 12420481 24 C PROGRAF TACROLIMUSTACROLIMUS ANHYDROUS 1 Oral 4.7 MG, UNK 0 4.7 MG
124204812 12420481 25 C NORVASC AMLODIPINE BESYLATE 1 Oral 2.5 MG, UNK 0 2.5 MG TABLET
124204812 12420481 26 C LIPITOR ATORVASTATIN CALCIUM 1 Oral 5 MG, UNK 0 5 MG
124204812 12420481 27 C RENIVACE ENALAPRIL 1 Oral 5 MG, UNK 0 5 MG
124204812 12420481 28 C RENIVACE ENALAPRIL 1 Oral 2.5 MG, UNK 0 2.5 MG
124204812 12420481 29 C BAYASPIRIN ASPIRIN 1 Oral 100 MG, UNK 0 100 MG
124204812 12420481 30 C SLOW K POTASSIUM CHLORIDE 1 Oral 600 MG, UNK 0 600 MG
124204812 12420481 31 C LASIX FUROSEMIDE 1 Oral 20 MG, UNK Y 0 20 MG
124204812 12420481 32 C FLUITRAN TRICHLORMETHIAZIDE 1 Oral 1 MG, UNK Y 0 1 MG
124204812 12420481 33 C FLUITRAN TRICHLORMETHIAZIDE 1 Oral 2 MG, UNK Y 0 2 MG
124204812 12420481 34 C SAMSCA TOLVAPTAN 1 Oral 7.5 MG, UNK 0 7.5 MG

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
124204812 12420481 1 Heart transplant
124204812 12420481 8 Heart transplant
124204812 12420481 11 Heart transplant
124204812 12420481 25 Hypertension
124204812 12420481 26 Hyperlipidaemia
124204812 12420481 27 Hyperlipidaemia
124204812 12420481 29 Hyperlipidaemia
124204812 12420481 30 Hyperlipidaemia
124204812 12420481 31 Polyuria
124204812 12420481 32 Polyuria
124204812 12420481 34 Polyuria

Outcome of event

Event ID CASEID OUTC COD
124204812 12420481 HO
124204812 12420481 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
124204812 12420481 Atrioventricular block complete
124204812 12420481 Blood lactate dehydrogenase increased
124204812 12420481 Gamma-glutamyltransferase increased
124204812 12420481 Heart transplant rejection
124204812 12420481 Hypothyroidism

Reporting Sources (this data is often not reported and may therefore be missing here)

no results found

Therapies reported

Event ID CASEID DSG DRUG SEQ START DT END DT DUR DUR COD
124204812 12420481 1 20130524 20130603 0
124204812 12420481 2 20130604 20130620 0
124204812 12420481 3 20130621 20130708 0
124204812 12420481 4 20130709 20130711 0
124204812 12420481 5 20130712 20130828 0
124204812 12420481 6 20130829 20141212 0
124204812 12420481 7 20141213 20150413 0
124204812 12420481 8 20130408 20141030 0
124204812 12420481 9 20141031 20141204 0
124204812 12420481 10 20141205 0
124204812 12420481 11 20130307 20130527 0
124204812 12420481 12 20130528 20130603 0
124204812 12420481 13 20130604 20130620 0
124204812 12420481 14 20130621 20130706 0
124204812 12420481 15 20130707 20130710 0
124204812 12420481 16 20130711 20130711 0
124204812 12420481 17 20130712 20130712 0
124204812 12420481 18 20130713 20130719 0
124204812 12420481 19 20130720 20130930 0
124204812 12420481 20 20131001 0
124204812 12420481 21 20140410 20140612 0
124204812 12420481 22 20140613 20150305 0
124204812 12420481 23 20150306 20150508 0
124204812 12420481 24 20150509 0
124204812 12420481 25 20120416 0
124204812 12420481 29 20120509 0
124204812 12420481 30 20120513 0
124204812 12420481 32 20100821 0
124204812 12420481 33 20141208 0
124204812 12420481 34 20141209 0