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
122899074 12289907 4 F 20150526 20160805 20160421 20160811 EXP US-ASTELLAS-2015US018334 ASTELLAS 53.67 YR M Y 0.00000 20160811 MD US US

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
122899074 12289907 1 SS BLINDED ASP0113 INVESTIGATIONAL PRODUCT 1 Intramuscular 0 INJECTION
122899074 12289907 2 SS BLINDED ASP0113 INVESTIGATIONAL PRODUCT 1 Intramuscular 0 INJECTION
122899074 12289907 3 SS BLINDED ASP0113 INVESTIGATIONAL PRODUCT 1 Intramuscular 0 INJECTION
122899074 12289907 4 SS BLINDED ASP0113 INVESTIGATIONAL PRODUCT 1 Intramuscular 0 INJECTION
122899074 12289907 5 SS BLINDED ASP0113 INVESTIGATIONAL PRODUCT 1 Intramuscular 0 INJECTION
122899074 12289907 6 PS TACROLIMUS. TACROLIMUS 1 Oral 50708 2.5 MG FORMULATION UNKNOWN
122899074 12289907 7 SS TACROLIMUS. TACROLIMUS 1 Oral 50708 10 MG FORMULATION UNKNOWN
122899074 12289907 8 SS TACROLIMUS. TACROLIMUS 1 Oral 50708 8 MG FORMULATION UNKNOWN
122899074 12289907 9 SS TACROLIMUS. TACROLIMUS 1 Oral 50708 5.5 MG FORMULATION UNKNOWN
122899074 12289907 10 SS TACROLIMUS. TACROLIMUS 1 Oral 50708 4.5 MG FORMULATION UNKNOWN
122899074 12289907 11 SS TACROLIMUS. TACROLIMUS 1 Oral 50708 5 MG FORMULATION UNKNOWN
122899074 12289907 12 SS TACROLIMUS. TACROLIMUS 1 Oral 50708 4.5 MG FORMULATION UNKNOWN
122899074 12289907 13 SS TACROLIMUS. TACROLIMUS 1 Oral 50708 5 MG FORMULATION UNKNOWN
122899074 12289907 14 SS TACROLIMUS. TACROLIMUS 1 Oral 50708 7 MG FORMULATION UNKNOWN
122899074 12289907 15 SS TACROLIMUS. TACROLIMUS 1 Oral 50708 7.5 MG FORMULATION UNKNOWN
122899074 12289907 16 SS TACROLIMUS. TACROLIMUS 1 Oral 50708 8 MG FORMULATION UNKNOWN
122899074 12289907 17 SS TACROLIMUS. TACROLIMUS 1 Oral 50708 7 MG FORMULATION UNKNOWN
122899074 12289907 18 SS TACROLIMUS. TACROLIMUS 1 Oral 50708 7.5 MG FORMULATION UNKNOWN
122899074 12289907 19 SS TACROLIMUS. TACROLIMUS 1 Oral 50708 7 MG FORMULATION UNKNOWN
122899074 12289907 20 SS TACROLIMUS. TACROLIMUS 1 Oral 50708 7.5 MG FORMULATION UNKNOWN
122899074 12289907 21 SS TACROLIMUS. TACROLIMUS 1 Oral 50708 5.5 MG FORMULATION UNKNOWN
122899074 12289907 22 SS TACROLIMUS. TACROLIMUS 1 Oral 50708 6 MG FORMULATION UNKNOWN
122899074 12289907 23 SS TACROLIMUS. TACROLIMUS 1 Oral 50708 6 MG FORMULATION UNKNOWN
122899074 12289907 24 SS TACROLIMUS. TACROLIMUS 1 Oral 50708 7.5 MG FORMULATION UNKNOWN
122899074 12289907 25 SS TACROLIMUS. TACROLIMUS 1 Oral 50708 3.5 MG FORMULATION UNKNOWN
122899074 12289907 26 SS TACROLIMUS. TACROLIMUS 1 Oral 50708 5 MG FORMULATION UNKNOWN
122899074 12289907 27 SS TACROLIMUS. TACROLIMUS 1 Oral 50708 6.5 MG FORMULATION UNKNOWN
122899074 12289907 28 SS TACROLIMUS. TACROLIMUS 1 Oral 50708 8.5 MG FORMULATION UNKNOWN
122899074 12289907 29 SS MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL 1 Oral 0 2000 MG FORMULATION UNKNOWN
122899074 12289907 30 SS MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL 1 Oral 0 1500 MG FORMULATION UNKNOWN
122899074 12289907 31 SS MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL 1 Oral 0 1000 MG FORMULATION UNKNOWN
122899074 12289907 32 SS MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL 1 Oral 0 500 MG FORMULATION UNKNOWN
122899074 12289907 33 SS MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL 1 Oral 0 1000 MG FORMULATION UNKNOWN
122899074 12289907 34 SS MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL 1 Oral 0 2000 MG FORMULATION UNKNOWN
122899074 12289907 35 C VITAMIN D /00107901/ ERGOCALCIFEROL 1 Oral UNK UNK, UNKNOWN FREQ. U 0 FORMULATION UNKNOWN
122899074 12289907 36 C OMEPRAZOLE. OMEPRAZOLE 1 Oral UNK UNK, UNKNOWN FREQ. U 0 FORMULATION UNKNOWN
122899074 12289907 37 C OMEPRAZOLE. OMEPRAZOLE 1 U 0 FORMULATION UNKNOWN
122899074 12289907 38 C MUPIROCIN. MUPIROCIN 1 Topical UNK UNK, UNKNOWN FREQ. U 0 OINTMENT
122899074 12289907 39 C ATIVAN LORAZEPAM 1 Oral UNK UNK, UNKNOWN FREQ. U 0 FORMULATION UNKNOWN
122899074 12289907 40 C ATIVAN LORAZEPAM 1 U 0 FORMULATION UNKNOWN
122899074 12289907 41 C OXYCODONE OXYCODONE 1 Oral UNK UNK, UNKNOWN FREQ. U 0 FORMULATION UNKNOWN
122899074 12289907 42 C OXYCODONE OXYCODONE 1 U 0 FORMULATION UNKNOWN
122899074 12289907 43 C OXYCODONE OXYCODONE 1 U 0 FORMULATION UNKNOWN
122899074 12289907 44 C ELIQUIS APIXABAN 1 Oral UNK UNK, UNKNOWN FREQ. U 0 FORMULATION UNKNOWN
122899074 12289907 45 C ELIQUIS APIXABAN 1 U 0 FORMULATION UNKNOWN
122899074 12289907 46 C MAGNESIUM SULFATE. MAGNESIUM SULFATE 1 Intravenous (not otherwise specified) UNK UNK, UNKNOWN FREQ. U 0 FORMULATION UNKNOWN
122899074 12289907 47 C TRAMADOL. TRAMADOL 1 Oral UNK UNK, UNKNOWN FREQ. U 0 FORMULATION UNKNOWN
122899074 12289907 48 C TRAMADOL. TRAMADOL 1 U 0 FORMULATION UNKNOWN
122899074 12289907 49 C MULTIVITAMIN /00097801/ VITAMINS 1 Oral UNK UNK, UNKNOWN FREQ. U 0 FORMULATION UNKNOWN
122899074 12289907 50 C ZOFRAN ONDANSETRON HYDROCHLORIDE 1 Oral UNK UNK, UNKNOWN FREQ. U 0 FORMULATION UNKNOWN
122899074 12289907 51 C ZOFRAN ONDANSETRON HYDROCHLORIDE 1 U 0 FORMULATION UNKNOWN
122899074 12289907 52 C ACETAMINOPHEN. ACETAMINOPHEN 1 Oral UNK UNK, UNKNOWN FREQ. U 0 FORMULATION UNKNOWN
122899074 12289907 53 C DELSYM DEXTROMETHORPHAN 1 Oral UNK UNK, UNKNOWN FREQ. U 0 FORMULATION UNKNOWN
122899074 12289907 54 C DEXAMETHASONE. DEXAMETHASONE 1 Sublingual UNK UNK, UNKNOWN FREQ. U 0 FORMULATION UNKNOWN
122899074 12289907 55 C DAPSONE. DAPSONE 1 Oral UNK UNK, UNKNOWN FREQ. U 0 FORMULATION UNKNOWN
122899074 12289907 56 C PENICILLIN VK PENICILLIN V POTASSIUM 1 Oral UNK UNK, UNKNOWN FREQ. U 0 FORMULATION UNKNOWN
122899074 12289907 57 C NYSTATIN. NYSTATIN 1 Oral UNK UNK, UNKNOWN FREQ. U 0 FORMULATION UNKNOWN
122899074 12289907 58 C TRIAMCINOLONE TRIAMCINOLONE 1 Topical UNK UNK, UNKNOWN FREQ. U 0 FORMULATION UNKNOWN
122899074 12289907 59 C IBRUTINIB IBRUTINIB 1 Oral UNK UNK, UNKNOWN FREQ. U 0 FORMULATION UNKNOWN
122899074 12289907 60 C ACYCLOVIR /00587301/ ACYCLOVIR 1 Oral U 0 1600 MG FORMULATION UNKNOWN
122899074 12289907 61 C ACYCLOVIR /00587301/ ACYCLOVIR 1 Oral U 0 800 MG FORMULATION UNKNOWN
122899074 12289907 62 C ACYCLOVIR /00587301/ ACYCLOVIR 1 Oral U 0 1600 MG FORMULATION UNKNOWN

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
122899074 12289907 1 Immunisation
122899074 12289907 6 Prophylaxis against graft versus host disease
122899074 12289907 29 Prophylaxis against graft versus host disease
122899074 12289907 35 Vitamin D deficiency
122899074 12289907 36 Dyspepsia
122899074 12289907 37 Gastrooesophageal reflux disease
122899074 12289907 38 Chronic sinusitis
122899074 12289907 39 Nausea
122899074 12289907 40 Vomiting
122899074 12289907 41 Pain
122899074 12289907 42 Arthralgia
122899074 12289907 43 Arthralgia
122899074 12289907 44 Thrombosis
122899074 12289907 45 Hypercoagulation
122899074 12289907 46 Hypomagnesaemia
122899074 12289907 47 Headache
122899074 12289907 48 Pain
122899074 12289907 49 Malnutrition
122899074 12289907 50 Nausea
122899074 12289907 51 Vomiting
122899074 12289907 52 Pneumonia
122899074 12289907 53 Cough
122899074 12289907 54 Oral pain
122899074 12289907 55 Pneumocystis jirovecii pneumonia
122899074 12289907 56 Bacterial infection
122899074 12289907 57 Oral pain
122899074 12289907 58 Acute graft versus host disease in skin
122899074 12289907 59 Chronic lymphocytic leukaemia
122899074 12289907 60 Prophylaxis

Outcome of event

Event ID CASEID OUTC COD
122899074 12289907 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
122899074 12289907 Bronchopulmonary aspergillosis
122899074 12289907 Hypoxia
122899074 12289907 Lower respiratory tract infection bacterial

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
122899074 12289907 1 20141121 20141121 0
122899074 12289907 2 20141219 20141219 0
122899074 12289907 3 20150123 20150123 0
122899074 12289907 4 20150225 20150225 0
122899074 12289907 5 20150526 20150526 0
122899074 12289907 6 20150505 20150606 0
122899074 12289907 7 20141122 20141128 0
122899074 12289907 8 20141128 20141205 0
122899074 12289907 9 20141205 20141208 0
122899074 12289907 10 20141209 20141222 0
122899074 12289907 11 20141223 20150108 0
122899074 12289907 12 20150109 20150116 0
122899074 12289907 13 20150117 20150206 0
122899074 12289907 14 20150207 20150223 0
122899074 12289907 15 20150224 20150302 0
122899074 12289907 16 20150303 20150309 0
122899074 12289907 17 20150310 20150323 0
122899074 12289907 18 20150324 20150326 0
122899074 12289907 19 20150327 20150331 0
122899074 12289907 20 20150401 20150405 0
122899074 12289907 21 20150406 20150420 0
122899074 12289907 22 20150421 20150424 0
122899074 12289907 23 20150425 20150427 0
122899074 12289907 24 20150428 20150504 0
122899074 12289907 25 20150606 20150616 0
122899074 12289907 26 20150616 20150619 0
122899074 12289907 27 20150619 20150623 0
122899074 12289907 28 20150623 0
122899074 12289907 29 20150504 20150604 0
122899074 12289907 30 20141125 20141226 0
122899074 12289907 31 20150604 20150623 0
122899074 12289907 32 20150623 20150630 0
122899074 12289907 33 20150630 20150705 0
122899074 12289907 34 20150705 0
122899074 12289907 35 20141113 0
122899074 12289907 36 20141128 0
122899074 12289907 38 20141001 0
122899074 12289907 39 20141121 0
122899074 12289907 41 20141121 0
122899074 12289907 44 20150122 0
122899074 12289907 46 20150123 0
122899074 12289907 47 20141205 0
122899074 12289907 49 20141205 0
122899074 12289907 50 20141121 0
122899074 12289907 52 20150324 0
122899074 12289907 53 20150327 0
122899074 12289907 54 20150504 0
122899074 12289907 55 20150330 0
122899074 12289907 56 20150420 0
122899074 12289907 57 20150518 0
122899074 12289907 58 20150414 0
122899074 12289907 59 20150406 20150526 0
122899074 12289907 60 20141121 20141212 0
122899074 12289907 61 20141212 20150302 0
122899074 12289907 62 20150302 0