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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
103498746 | 10349874 | 6 | F | 20120704 | 20160907 | 20140730 | 20160913 | EXP | JP-ASTELLAS-2013JP007211 | ASTELLAS | 62.37 | YR | F | Y | 53.00000 | KG | 20160913 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
103498746 | 10349874 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 5115 | MG | 50708 | 3 | MG | CAPSULE | QD | |||||
103498746 | 10349874 | 2 | I | TACROLIMUS. | TACROLIMUS | 1 | Oral | 5115 | MG | 50708 | 3 | MG | CAPSULE | QD | |||||
103498746 | 10349874 | 3 | I | TACROLIMUS. | TACROLIMUS | 1 | Oral | 5115 | MG | 50708 | 2 | MG | CAPSULE | QD | |||||
103498746 | 10349874 | 4 | I | TACROLIMUS. | TACROLIMUS | 1 | Oral | 5115 | MG | U | 50708 | 1.5 | MG | CAPSULE | QD | ||||
103498746 | 10349874 | 5 | I | TACROLIMUS. | TACROLIMUS | 1 | Oral | 5115 | MG | U | 50708 | 2 | MG | CAPSULE | QD | ||||
103498746 | 10349874 | 6 | I | TACROLIMUS. | TACROLIMUS | 1 | Oral | 5115 | MG | U | 50708 | 1 | MG | CAPSULE | QD | ||||
103498746 | 10349874 | 7 | SS | Funguard | MICAFUNGIN SODIUM | 1 | Unknown | 4500 | MG | 0 | 450 | MG | INJECTION | QD | |||||
103498746 | 10349874 | 8 | SS | Funguard | MICAFUNGIN SODIUM | 1 | 4500 | MG | 0 | INJECTION | |||||||||
103498746 | 10349874 | 9 | I | VFEND | VORICONAZOLE | 1 | Oral | 0 | 800 | MG | TABLET | QD | |||||||
103498746 | 10349874 | 10 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 15 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 11 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 12.5 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 12 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 10 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 13 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 9 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 14 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 8 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 15 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 7 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 16 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 6 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 17 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 5 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 18 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 4 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 19 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 3 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 20 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 2.5 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 21 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 2 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 22 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 30 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 23 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 27 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 24 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 25 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 25 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 40 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 26 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 35 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 27 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 30 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 28 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 25 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 29 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 20 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 30 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 18 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 31 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 17 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 32 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 16 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 33 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 15 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 34 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 14 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 35 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 10 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 36 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 9 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 37 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 8 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 38 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 7.5 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 39 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 7 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 40 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 6 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 41 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 11145 | MG | Y | 0 | 5 | MG | PER ORAL NOS | QD | ||||
103498746 | 10349874 | 42 | SS | SOLU-CORTEF | HYDROCORTISONE SODIUM SUCCINATE | 1 | Unknown | 4500 | MG | 0 | 300 | MG | INJECTION | QD | |||||
103498746 | 10349874 | 43 | SS | SOLU-CORTEF | HYDROCORTISONE SODIUM SUCCINATE | 1 | Unknown | 4500 | MG | 0 | 300 | MG | INJECTION | QD | |||||
103498746 | 10349874 | 44 | SS | SOLU-CORTEF | HYDROCORTISONE SODIUM SUCCINATE | 1 | Unknown | 4500 | MG | 0 | 300 | MG | INJECTION | QD | |||||
103498746 | 10349874 | 45 | SS | PREDNISOLONE SODIUM SUCCINATE | PREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 150 | MG | 0 | 50 | MG | INJECTION | QD | |||||
103498746 | 10349874 | 46 | SS | BAKTAR | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 84 | G | 0 | 4 | G | PER ORAL NOS | QD | |||||
103498746 | 10349874 | 47 | SS | BAKTAR | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 84 | G | 0 | 1 | G | PER ORAL NOS | QD | |||||
103498746 | 10349874 | 48 | SS | BAKTAR | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 84 | G | 0 | 4 | G | PER ORAL NOS | QD | |||||
103498746 | 10349874 | 49 | SS | BAKTAR | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 84 | G | 0 | 1 | G | PER ORAL NOS | QD | |||||
103498746 | 10349874 | 50 | SS | MEROPEN /01250501/ | MEROPENEM | 1 | Unknown | 12 | G | 0 | 3 | G | INJECTION | QD | |||||
103498746 | 10349874 | 51 | SS | MEROPEN /01250501/ | MEROPENEM | 1 | 12 | G | 0 | INJECTION | |||||||||
103498746 | 10349874 | 52 | SS | VANCOMYCIN /00314402/ | VANCOMYCIN | 1 | Unknown | 15 | G | 0 | 1.5 | G | INJECTION | QD | |||||
103498746 | 10349874 | 53 | SS | VANCOMYCIN /00314402/ | VANCOMYCIN | 1 | 15 | G | 0 | INJECTION | |||||||||
103498746 | 10349874 | 54 | C | GASTER | FAMOTIDINE | 1 | Oral | U | 0 | 10 | MG | ORODISPERSIBLE TABLET | QD | ||||||
103498746 | 10349874 | 55 | C | BLOPRESS | CANDESARTAN CILEXETIL | 1 | Oral | U | 0 | 8 | MG | TABLET | QD | ||||||
103498746 | 10349874 | 56 | C | EVISTA | RALOXIFENE HYDROCHLORIDE | 1 | Oral | U | 0 | 60 | MG | TABLET | QD | ||||||
103498746 | 10349874 | 57 | C | LIPOVAS /00848101/ | SIMVASTATIN | 1 | Oral | U | 0 | 5 | MG | TABLET | QD | ||||||
103498746 | 10349874 | 58 | C | ARTIST | CARVEDILOL | 1 | Oral | 6620 | MG | U | 0 | 5 | MG | TABLET | QD | ||||
103498746 | 10349874 | 59 | C | ZYLORIC | ALLOPURINOL | 1 | Oral | 59600 | MG | U | 0 | 100 | MG | TABLET | QD | ||||
103498746 | 10349874 | 60 | C | TAKEPRON | LANSOPRAZOLE | 1 | Oral | U | 0 | 15 | MG | ORODISPERSIBLE TABLET | QD | ||||||
103498746 | 10349874 | 61 | C | MIYA-BM | CLOSTRIDIUM BUTYRICUM SPORES STRAIN M-55 | 1 | Oral | 30 | G | U | 0 | 3 | G | FINE GRANULE | QD | ||||
103498746 | 10349874 | 62 | C | HUMAN NORMAL IMMUNOGLOBULIN | HUMAN IMMUNOGLOBULIN G | 1 | Unknown | 15 | G | U | 0 | 5 | G | INJECTION | QD | ||||
103498746 | 10349874 | 63 | C | HUMAN NORMAL IMMUNOGLOBULIN | HUMAN IMMUNOGLOBULIN G | 1 | 15 | G | U | 0 | INJECTION | ||||||||
103498746 | 10349874 | 64 | C | ROZEREM | RAMELTEON | 1 | Oral | U | 0 | 8 | MG | TABLET | QD | ||||||
103498746 | 10349874 | 65 | C | BIOFERMIN /01617201/ | BACILLUS SUBTILISLACTOBACILLUS ACIDOPHILUSSTREPTOCOCCUS FAECAIS | 1 | Oral | U | 0 | 3 | G | QD | |||||||
103498746 | 10349874 | 66 | C | BIOFERMIN /01617201/ | BACILLUS SUBTILISLACTOBACILLUS ACIDOPHILUSSTREPTOCOCCUS FAECAIS | 1 | U | 0 | |||||||||||
103498746 | 10349874 | 67 | C | LIPIDIL | FENOFIBRATE | 1 | Oral | U | 0 | 80 | MG | PER ORAL NOS | QD | ||||||
103498746 | 10349874 | 68 | C | RHYTHMY | RILMAZAFONE HYDROCHLORIDE | 1 | Oral | U | 0 | 2 | MG | PER ORAL NOS | QD | ||||||
103498746 | 10349874 | 69 | C | HYPEN /00340101/ | 2 | Oral | U | 0 | 400 | MG | PER ORAL NOS | QD | |||||||
103498746 | 10349874 | 70 | C | LIVALO | PITAVASTATIN CALCIUM | 1 | Oral | U | 0 | 1 | MG | PER ORAL NOS | QD |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
103498746 | 10349874 | 1 | Lupus nephritis |
103498746 | 10349874 | 7 | Nocardiosis |
103498746 | 10349874 | 8 | Enterobacter pneumonia |
103498746 | 10349874 | 9 | Bronchopulmonary aspergillosis |
103498746 | 10349874 | 10 | Lupus nephritis |
103498746 | 10349874 | 11 | Arthralgia |
103498746 | 10349874 | 12 | Pyrexia |
103498746 | 10349874 | 13 | DNA antibody positive |
103498746 | 10349874 | 42 | Lupus nephritis |
103498746 | 10349874 | 45 | Lupus nephritis |
103498746 | 10349874 | 46 | Nocardiosis |
103498746 | 10349874 | 47 | Pneumonia |
103498746 | 10349874 | 48 | Prophylaxis |
103498746 | 10349874 | 50 | Nocardiosis |
103498746 | 10349874 | 51 | Pneumonia |
103498746 | 10349874 | 52 | Nocardiosis |
103498746 | 10349874 | 53 | Pneumonia |
103498746 | 10349874 | 54 | Prophylaxis |
103498746 | 10349874 | 55 | Product used for unknown indication |
103498746 | 10349874 | 56 | Prophylaxis |
103498746 | 10349874 | 57 | Product used for unknown indication |
103498746 | 10349874 | 58 | Product used for unknown indication |
103498746 | 10349874 | 59 | Product used for unknown indication |
103498746 | 10349874 | 60 | Prophylaxis against gastrointestinal ulcer |
103498746 | 10349874 | 61 | Diarrhoea |
103498746 | 10349874 | 62 | Nocardiosis |
103498746 | 10349874 | 63 | Pneumonia |
103498746 | 10349874 | 64 | Insomnia |
103498746 | 10349874 | 65 | Prophylaxis |
103498746 | 10349874 | 66 | Diarrhoea |
103498746 | 10349874 | 67 | Hyperlipidaemia |
103498746 | 10349874 | 68 | Insomnia |
103498746 | 10349874 | 69 | Arthralgia |
103498746 | 10349874 | 70 | Hyperlipidaemia |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
103498746 | 10349874 | HO |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
103498746 | 10349874 | Arthralgia | |
103498746 | 10349874 | Bronchopulmonary aspergillosis | |
103498746 | 10349874 | DNA antibody positive | |
103498746 | 10349874 | Diarrhoea | |
103498746 | 10349874 | Drug interaction | |
103498746 | 10349874 | Drug level increased | |
103498746 | 10349874 | Hyperlipidaemia | |
103498746 | 10349874 | Insomnia | |
103498746 | 10349874 | Muscular weakness | |
103498746 | 10349874 | Nocardiosis | |
103498746 | 10349874 | Pneumonia | |
103498746 | 10349874 | Pneumothorax | |
103498746 | 10349874 | Pyrexia | |
103498746 | 10349874 | Renal disorder |
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 |
---|---|---|---|---|---|---|
103498746 | 10349874 | 1 | 20080123 | 20120909 | 0 | |
103498746 | 10349874 | 2 | 20120921 | 20121104 | 0 | |
103498746 | 10349874 | 3 | 20121105 | 20121209 | 0 | |
103498746 | 10349874 | 4 | 20121210 | 20150331 | 0 | |
103498746 | 10349874 | 5 | 20150401 | 20151208 | 0 | |
103498746 | 10349874 | 6 | 20151209 | 0 | ||
103498746 | 10349874 | 7 | 20120911 | 20120920 | 0 | |
103498746 | 10349874 | 9 | 20121025 | 20121125 | 0 | |
103498746 | 10349874 | 10 | 20080123 | 20080318 | 0 | |
103498746 | 10349874 | 11 | 20080319 | 20080511 | 0 | |
103498746 | 10349874 | 12 | 20080512 | 20080916 | 0 | |
103498746 | 10349874 | 13 | 20080917 | 20081118 | 0 | |
103498746 | 10349874 | 14 | 20081119 | 20090128 | 0 | |
103498746 | 10349874 | 15 | 20090129 | 20090422 | 0 | |
103498746 | 10349874 | 16 | 20090423 | 20090722 | 0 | |
103498746 | 10349874 | 17 | 20090723 | 20100428 | 0 | |
103498746 | 10349874 | 18 | 20100429 | 20101027 | 0 | |
103498746 | 10349874 | 19 | 20101028 | 20110126 | 0 | |
103498746 | 10349874 | 20 | 20110127 | 20110728 | 0 | |
103498746 | 10349874 | 21 | 20110729 | 20120703 | 0 | |
103498746 | 10349874 | 22 | 20120704 | 20120724 | 0 | |
103498746 | 10349874 | 23 | 20120725 | 20120828 | 0 | |
103498746 | 10349874 | 24 | 20120829 | 20120910 | 0 | |
103498746 | 10349874 | 25 | 20120918 | 20121025 | 0 | |
103498746 | 10349874 | 26 | 20121026 | 20121101 | 0 | |
103498746 | 10349874 | 27 | 20121102 | 20121108 | 0 | |
103498746 | 10349874 | 28 | 20121109 | 20121115 | 0 | |
103498746 | 10349874 | 29 | 20121116 | 20121125 | 0 | |
103498746 | 10349874 | 30 | 20121126 | 20121226 | 0 | |
103498746 | 10349874 | 31 | 20121227 | 20130123 | 0 | |
103498746 | 10349874 | 32 | 20130124 | 20130220 | 0 | |
103498746 | 10349874 | 33 | 20130221 | 20130320 | 0 | |
103498746 | 10349874 | 34 | 20130321 | 20130425 | 0 | |
103498746 | 10349874 | 35 | 20131004 | 20140211 | 0 | |
103498746 | 10349874 | 36 | 20140212 | 20140415 | 0 | |
103498746 | 10349874 | 37 | 20140416 | 20150120 | 0 | |
103498746 | 10349874 | 38 | 20150121 | 20150915 | 0 | |
103498746 | 10349874 | 39 | 20150916 | 20151027 | 0 | |
103498746 | 10349874 | 40 | 20151028 | 20160119 | 0 | |
103498746 | 10349874 | 41 | 20160120 | 0 | ||
103498746 | 10349874 | 42 | 20120911 | 20120914 | 0 | |
103498746 | 10349874 | 43 | 20120919 | 20120923 | 0 | |
103498746 | 10349874 | 44 | 20120928 | 20121004 | 0 | |
103498746 | 10349874 | 45 | 20120915 | 20120917 | 0 | |
103498746 | 10349874 | 46 | 20120913 | 20130320 | 0 | |
103498746 | 10349874 | 47 | 20130321 | 20140114 | 0 | |
103498746 | 10349874 | 48 | 20140115 | 20150513 | 0 | |
103498746 | 10349874 | 49 | 20150514 | 0 | ||
103498746 | 10349874 | 50 | 20120910 | 20120913 | 0 | |
103498746 | 10349874 | 52 | 20120911 | 20120920 | 0 | |
103498746 | 10349874 | 54 | 20091020 | 0 | ||
103498746 | 10349874 | 55 | 20120912 | 0 | ||
103498746 | 10349874 | 56 | 20120913 | 0 | ||
103498746 | 10349874 | 57 | 20100728 | 0 | ||
103498746 | 10349874 | 58 | 20090129 | 20120913 | 0 | |
103498746 | 10349874 | 59 | 20110127 | 20120913 | 0 | |
103498746 | 10349874 | 60 | 20120924 | 0 | ||
103498746 | 10349874 | 61 | 20120924 | 20131022 | 0 | |
103498746 | 10349874 | 62 | 20120911 | 20120913 | 0 | |
103498746 | 10349874 | 64 | 20130318 | 0 | ||
103498746 | 10349874 | 65 | 20131021 | 0 | ||
103498746 | 10349874 | 67 | 20131120 | 0 | ||
103498746 | 10349874 | 68 | 20130318 | 0 | ||
103498746 | 10349874 | 69 | 20131120 | 20150331 | 0 | |
103498746 | 10349874 | 70 | 20130318 | 20131119 | 0 |