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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116174492 | 11617449 | 2 | F | 20090713 | 20160808 | 20151009 | 20160817 | EXP | JP-ASTELLAS-2009JP007358 | ASTELLAS | 65.00 | YR | M | Y | 0.00000 | 20160817 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116174492 | 11617449 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 163 | MG | 50708 | 1 | MG | CAPSULE | QD | |||||
| 116174492 | 11617449 | 2 | I | TACROLIMUS. | TACROLIMUS | 1 | Oral | 0.5 MG, ONCE DAILY | 163 | MG | 50708 | .5 | MG | CAPSULE | QD | ||||
| 116174492 | 11617449 | 3 | I | TACROLIMUS. | TACROLIMUS | 1 | Oral | 0.5 MG, EVERY OTHER DAY | 163 | MG | 50708 | .5 | MG | CAPSULE | QOD | ||||
| 116174492 | 11617449 | 4 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 3442 | MG | U | 0 | 10 | MG | PER ORAL NOS | QD | ||||
| 116174492 | 11617449 | 5 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 3442 | MG | U | 0 | 9 | MG | PER ORAL NOS | QD | ||||
| 116174492 | 11617449 | 6 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 3442 | MG | U | 0 | 8 | MG | PER ORAL NOS | QD | ||||
| 116174492 | 11617449 | 7 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 3442 | MG | U | 0 | 7 | MG | PER ORAL NOS | QD | ||||
| 116174492 | 11617449 | 8 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 3442 | MG | U | 0 | 10 | MG | PER ORAL NOS | QD | ||||
| 116174492 | 11617449 | 9 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 3442 | MG | U | 0 | 9 | MG | PER ORAL NOS | QD | ||||
| 116174492 | 11617449 | 10 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 3442 | MG | U | 0 | 8 | MG | PER ORAL NOS | QD | ||||
| 116174492 | 11617449 | 11 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 3442 | MG | U | 0 | 30 | MG | PER ORAL NOS | QD | ||||
| 116174492 | 11617449 | 12 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 3442 | MG | U | 0 | 25 | MG | PER ORAL NOS | QD | ||||
| 116174492 | 11617449 | 13 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 3442 | MG | U | 0 | 20 | MG | PER ORAL NOS | QD | ||||
| 116174492 | 11617449 | 14 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 3442 | MG | U | 0 | 15 | MG | PER ORAL NOS | QD | ||||
| 116174492 | 11617449 | 15 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 3442 | MG | U | 0 | 30 | MG | PER ORAL NOS | QD | ||||
| 116174492 | 11617449 | 16 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 3442 | MG | U | 0 | 10 | MG | PER ORAL NOS | QD | ||||
| 116174492 | 11617449 | 17 | C | LASIX | FUROSEMIDE | 1 | Oral | U | 0 | 40 | MG | TABLET | QD | ||||||
| 116174492 | 11617449 | 18 | C | WARFARIN | WARFARIN | 1 | Oral | U | 0 | 1 | MG | TABLET | QD | ||||||
| 116174492 | 11617449 | 19 | C | ZYLORIC | ALLOPURINOL | 1 | Oral | U | 0 | 100 | MG | TABLET | QD | ||||||
| 116174492 | 11617449 | 20 | C | NORVASC | AMLODIPINE BESYLATE | 1 | Oral | U | 0 | 5 | MG | TABLET | QD | ||||||
| 116174492 | 11617449 | 21 | C | MAINTATE | BISOPROLOL FUMARATE | 1 | Oral | U | 0 | 5 | MG | TABLET | QD | ||||||
| 116174492 | 11617449 | 22 | C | DIOVAN | VALSARTAN | 1 | Oral | U | 0 | 160 | MG | TABLET | QD | ||||||
| 116174492 | 11617449 | 23 | C | MEXITIL | MEXILETINE HYDROCHLORIDE | 1 | Oral | U | 0 | 300 | MG | CAPSULE | QD | ||||||
| 116174492 | 11617449 | 24 | I | ITRIZOLE | ITRACONAZOLE | 1 | Oral | U | 0 | 20 | ML | ORAL SOLUTION | QD | ||||||
| 116174492 | 11617449 | 25 | C | FOSAMAC | ALENDRONATE SODIUM | 1 | Oral | U | 0 | 5 | MG | TABLET | QD | ||||||
| 116174492 | 11617449 | 26 | C | ALFAROL | ALFACALCIDOL | 1 | Oral | 0.5 ?G, ONCE DAILY | U | 0 | .5 | UG | PER ORAL NOS | QD | |||||
| 116174492 | 11617449 | 27 | C | TAKEPRON | LANSOPRAZOLE | 1 | Oral | U | 0 | 30 | MG | ORODISPERSIBLE TABLET | QD | ||||||
| 116174492 | 11617449 | 28 | C | BAKTAR | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | U | 0 | 1 | DF | TABLET | QD | ||||||
| 116174492 | 11617449 | 29 | C | HARNAL | TAMSULOSIN HYDROCHLORIDE | 1 | Oral | 0.2 MG, ONCE DAILY | U | 0 | .2 | MG | ORODISPERSIBLE TABLET | QD | |||||
| 116174492 | 11617449 | 30 | C | PROSTAL /00093602/ | 2 | Oral | U | 0 | 100 | MG | PER ORAL NOS | QD | |||||||
| 116174492 | 11617449 | 31 | C | CASODEX | BICALUTAMIDE | 1 | Oral | 80 MG, ONCE DAILY, MORNING | U | 0 | 80 | MG | PER ORAL NOS | QD | |||||
| 116174492 | 11617449 | 32 | C | ODYNE | FLUTAMIDE | 1 | Unknown | U | 0 | 375 | MG | TABLET | QD | ||||||
| 116174492 | 11617449 | 33 | C | DOCETAXEL. | DOCETAXEL | 1 | Unknown | U | 0 | 50 | MG | FORMULATION UNKNOWN | /wk | ||||||
| 116174492 | 11617449 | 34 | C | LEUPLIN | LEUPROLIDE ACETATE | 1 | Unknown | U | 0 | 11.25 | MG | FORMULATION UNKNOWN | QD | ||||||
| 116174492 | 11617449 | 35 | C | BONALON | ALENDRONATE SODIUM | 1 | Oral | U | 0 | 35 | MG | PER ORAL NOS | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116174492 | 11617449 | 1 | Lupus nephritis |
| 116174492 | 11617449 | 4 | Lupus nephritis |
| 116174492 | 11617449 | 17 | Lupus nephritis |
| 116174492 | 11617449 | 18 | Lupus nephritis |
| 116174492 | 11617449 | 19 | Hyperuricaemia |
| 116174492 | 11617449 | 20 | Hypertension |
| 116174492 | 11617449 | 21 | Hypertension |
| 116174492 | 11617449 | 22 | Hypertension |
| 116174492 | 11617449 | 23 | Ventricular tachycardia |
| 116174492 | 11617449 | 24 | Prophylaxis |
| 116174492 | 11617449 | 25 | Prophylaxis |
| 116174492 | 11617449 | 26 | Prophylaxis |
| 116174492 | 11617449 | 27 | Prophylaxis |
| 116174492 | 11617449 | 28 | Prophylaxis |
| 116174492 | 11617449 | 29 | Prostate cancer |
| 116174492 | 11617449 | 30 | Prostate cancer |
| 116174492 | 11617449 | 31 | Prostate cancer |
| 116174492 | 11617449 | 32 | Prostate cancer |
| 116174492 | 11617449 | 33 | Prostate cancer |
| 116174492 | 11617449 | 34 | Prostate cancer |
| 116174492 | 11617449 | 35 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116174492 | 11617449 | OT |
| 116174492 | 11617449 | DE |
| 116174492 | 11617449 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116174492 | 11617449 | Drug interaction | |
| 116174492 | 11617449 | Nephrotic syndrome | |
| 116174492 | 11617449 | Pleural effusion | |
| 116174492 | 11617449 | Prostate cancer | |
| 116174492 | 11617449 | Tremor | |
| 116174492 | 11617449 | Urinary retention |
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 |
|---|---|---|---|---|---|---|
| 116174492 | 11617449 | 1 | 20090518 | 20090713 | 0 | |
| 116174492 | 11617449 | 2 | 20090727 | 20090824 | 0 | |
| 116174492 | 11617449 | 3 | 20090824 | 20100831 | 0 | |
| 116174492 | 11617449 | 4 | 20090614 | 0 | ||
| 116174492 | 11617449 | 5 | 20090615 | 20090727 | 0 | |
| 116174492 | 11617449 | 6 | 20090728 | 20090824 | 0 | |
| 116174492 | 11617449 | 7 | 20090825 | 20100315 | 0 | |
| 116174492 | 11617449 | 8 | 20100316 | 20100412 | 0 | |
| 116174492 | 11617449 | 9 | 20100413 | 20100524 | 0 | |
| 116174492 | 11617449 | 10 | 20100525 | 20100927 | 0 | |
| 116174492 | 11617449 | 11 | 20100928 | 20101108 | 0 | |
| 116174492 | 11617449 | 12 | 20101109 | 20101226 | 0 | |
| 116174492 | 11617449 | 13 | 20101227 | 20110424 | 0 | |
| 116174492 | 11617449 | 14 | 20110425 | 0 | ||
| 116174492 | 11617449 | 19 | 20100831 | 0 | ||
| 116174492 | 11617449 | 20 | 20100831 | 0 | ||
| 116174492 | 11617449 | 22 | 20100831 | 0 | ||
| 116174492 | 11617449 | 23 | 20100525 | 0 | ||
| 116174492 | 11617449 | 24 | 20100525 | 0 | ||
| 116174492 | 11617449 | 25 | 20100831 | 0 | ||
| 116174492 | 11617449 | 26 | 20100831 | 0 | ||
| 116174492 | 11617449 | 29 | 20100831 | 0 | ||
| 116174492 | 11617449 | 30 | 20100908 | 20100913 | 0 | |
| 116174492 | 11617449 | 31 | 20100914 | 20120130 | 0 | |
| 116174492 | 11617449 | 32 | 20120131 | 20120820 | 0 | |
| 116174492 | 11617449 | 33 | 20120821 | 20131119 | 0 | |
| 116174492 | 11617449 | 34 | 20140117 | 0 | ||
| 116174492 | 11617449 | 35 | 20100901 | 0 |