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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125791481 | 12579148 | 1 | I | 20070919 | 20100107 | 20160721 | 20160721 | EXP | JP-ASTELLAS-2010JP000265 | ASTELLAS | 42.00 | YR | F | Y | 53.00000 | KG | 20160721 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125791481 | 12579148 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 93 | MG | 50708 | 3 | MG | CAPSULE | QD | |||||
| 125791481 | 12579148 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 93 | MG | U | 50708 | 2 | MG | CAPSULE | QD | ||||
| 125791481 | 12579148 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 93 | MG | U | 50708 | 3 | MG | CAPSULE | QD | ||||
| 125791481 | 12579148 | 4 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | U | 0 | 10 | MG | PER ORAL NOS | QD | ||||||
| 125791481 | 12579148 | 5 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | U | 0 | 15 | MG | PER ORAL NOS | QD | ||||||
| 125791481 | 12579148 | 6 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | U | 0 | 12.5 | MG | PER ORAL NOS | QD | ||||||
| 125791481 | 12579148 | 7 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | U | 0 | 10 | MG | PER ORAL NOS | QD | ||||||
| 125791481 | 12579148 | 8 | C | TAKEPRON | LANSOPRAZOLE | 1 | Oral | U | 0 | 15 | MG | CAPSULE | QD | ||||||
| 125791481 | 12579148 | 9 | C | TAKEPRON | LANSOPRAZOLE | 1 | Oral | U | 0 | 30 | MG | CAPSULE | QD | ||||||
| 125791481 | 12579148 | 10 | C | MUCOSTA | REBAMIPIDE | 1 | Oral | U | 0 | 200 | MG | TABLET | QD | ||||||
| 125791481 | 12579148 | 11 | C | ALFAROL | ALFACALCIDOL | 1 | Oral | U | 0 | 1 | UG | PER ORAL NOS | QD | ||||||
| 125791481 | 12579148 | 12 | C | ALFAROL | ALFACALCIDOL | 1 | Oral | 0.5 ?G, ONCE DAILY | U | 0 | .5 | UG | PER ORAL NOS | QD | |||||
| 125791481 | 12579148 | 13 | C | BAKTAR | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 1 TABLET, ONCE DAILY | U | 0 | 1 | DF | TABLET | QD | |||||
| 125791481 | 12579148 | 14 | C | NEGMIN | 2 | Unknown | U | 0 | 1 | ML | MOUTHWASH | QD | |||||||
| 125791481 | 12579148 | 15 | C | NEGMIN | 2 | Unknown | U | 0 | 60 | ML | MOUTHWASH | /month | |||||||
| 125791481 | 12579148 | 16 | C | BONALON | ALENDRONATE SODIUM | 1 | Oral | U | 0 | 35 | MG | TABLET | /wk | ||||||
| 125791481 | 12579148 | 17 | C | ACTONEL | RISEDRONATE SODIUM | 1 | Oral | U | 0 | 17.5 | MG | TABLET | /wk | ||||||
| 125791481 | 12579148 | 18 | C | CEFMETAZON | CEFMETAZOLE SODIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 125791481 | 12579148 | 19 | C | ARTIST | CARVEDILOL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 125791481 | 12579148 | 20 | C | WARFARIN | WARFARIN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 125791481 | 12579148 | 21 | C | NEORAL | CYCLOSPORINE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125791481 | 12579148 | 1 | Lupus nephritis |
| 125791481 | 12579148 | 4 | Lupus nephritis |
| 125791481 | 12579148 | 8 | Prophylaxis |
| 125791481 | 12579148 | 10 | Prophylaxis |
| 125791481 | 12579148 | 11 | Prophylaxis |
| 125791481 | 12579148 | 13 | Prophylaxis |
| 125791481 | 12579148 | 14 | Prophylaxis |
| 125791481 | 12579148 | 16 | Prophylaxis |
| 125791481 | 12579148 | 17 | Prophylaxis |
| 125791481 | 12579148 | 18 | Peritonitis |
| 125791481 | 12579148 | 19 | Acute myocardial infarction |
| 125791481 | 12579148 | 20 | Acute myocardial infarction |
| 125791481 | 12579148 | 21 | Lupus nephritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125791481 | 12579148 | OT |
| 125791481 | 12579148 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125791481 | 12579148 | Acute myocardial infarction | |
| 125791481 | 12579148 | Intentional product use issue | |
| 125791481 | 12579148 | Peritonitis | |
| 125791481 | 12579148 | White blood cell count increased |
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 |
|---|---|---|---|---|---|---|
| 125791481 | 12579148 | 1 | 20070820 | 20090118 | 0 | |
| 125791481 | 12579148 | 2 | 20090119 | 20100715 | 0 | |
| 125791481 | 12579148 | 3 | 20100716 | 20101001 | 0 | |
| 125791481 | 12579148 | 4 | 20071014 | 0 | ||
| 125791481 | 12579148 | 5 | 20071015 | 20090222 | 0 | |
| 125791481 | 12579148 | 6 | 20090223 | 20090329 | 0 | |
| 125791481 | 12579148 | 7 | 20090330 | 0 | ||
| 125791481 | 12579148 | 8 | 20091005 | 0 | ||
| 125791481 | 12579148 | 9 | 20091006 | 0 | ||
| 125791481 | 12579148 | 13 | 20091109 | 0 | ||
| 125791481 | 12579148 | 15 | 20080428 | 0 | ||
| 125791481 | 12579148 | 16 | 20071015 | 20080928 | 0 | |
| 125791481 | 12579148 | 17 | 20080929 | 0 |