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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122949382 | 12294938 | 2 | F | 20141028 | 20160628 | 20160422 | 20160705 | EXP | JP-ASTELLAS-2015JP008815 | ASTELLAS | 79.82 | YR | F | Y | 53.00000 | KG | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122949382 | 12294938 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 50708 | 2 | MG | CAPSULE | BID | |||||||
| 122949382 | 12294938 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | 50708 | CAPSULE | |||||||||||
| 122949382 | 12294938 | 3 | SS | PREDNISOLON /00016201/ | PREDNISOLONE | 1 | Oral | 840 | MG | U | 0 | 30 | MG | PER ORAL NOS | QD | ||||
| 122949382 | 12294938 | 4 | SS | PREDNISOLON /00016201/ | PREDNISOLONE | 1 | Oral | 840 | MG | U | 0 | 25 | MG | PER ORAL NOS | QD | ||||
| 122949382 | 12294938 | 5 | SS | PREDNISOLON /00016201/ | PREDNISOLONE | 1 | Oral | 840 | MG | U | 0 | 20 | MG | PER ORAL NOS | QD | ||||
| 122949382 | 12294938 | 6 | SS | PREDNISOLON /00016201/ | PREDNISOLONE | 1 | Oral | 840 | MG | U | 0 | 17.5 | MG | PER ORAL NOS | QD | ||||
| 122949382 | 12294938 | 7 | SS | PREDNISOLON /00016201/ | PREDNISOLONE | 1 | Oral | 840 | MG | U | 0 | 15 | MG | PER ORAL NOS | QD | ||||
| 122949382 | 12294938 | 8 | SS | PREDNISOLON /00016201/ | PREDNISOLONE | 1 | Oral | 840 | MG | U | 0 | 12.5 | MG | PER ORAL NOS | QD | ||||
| 122949382 | 12294938 | 9 | SS | PREDNISOLON /00016201/ | PREDNISOLONE | 1 | Oral | 840 | MG | U | 0 | 10 | MG | PER ORAL NOS | QD | ||||
| 122949382 | 12294938 | 10 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | PER ORAL NOS | ||||||||
| 122949382 | 12294938 | 11 | C | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | PER ORAL NOS | ||||||||
| 122949382 | 12294938 | 12 | C | BAKTAR | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | PER ORAL NOS | ||||||||
| 122949382 | 12294938 | 13 | C | BAKTAR | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | UNK, UNK, UNKNOWN FREQ. | U | 0 | PER ORAL NOS | ||||||||
| 122949382 | 12294938 | 14 | C | BONALON | ALENDRONATE SODIUM | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | PER ORAL NOS | ||||||||
| 122949382 | 12294938 | 15 | C | TENELIA | TENELIGLIPTIN | 1 | Oral | U | 0 | 20 | MG | PER ORAL NOS | QD | ||||||
| 122949382 | 12294938 | 16 | C | CRAVIT | LEVOFLOXACIN | 1 | Oral | U | 0 | 500 | MG | PER ORAL NOS | QD | ||||||
| 122949382 | 12294938 | 17 | C | TRANSAMIN | TRANEXAMIC ACID | 1 | Oral | U | 0 | 750 | MG | PER ORAL NOS | QD | ||||||
| 122949382 | 12294938 | 18 | C | MEIACT | CEFDITOREN PIVOXIL | 1 | Oral | U | 0 | 300 | MG | PER ORAL NOS | QD | ||||||
| 122949382 | 12294938 | 19 | C | CALONAL | ACETAMINOPHEN | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | PER ORAL NOS |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122949382 | 12294938 | 1 | Interstitial lung disease |
| 122949382 | 12294938 | 2 | Dermatomyositis |
| 122949382 | 12294938 | 3 | Product used for unknown indication |
| 122949382 | 12294938 | 10 | Prophylaxis |
| 122949382 | 12294938 | 11 | Product used for unknown indication |
| 122949382 | 12294938 | 12 | Prophylaxis |
| 122949382 | 12294938 | 14 | Prophylaxis |
| 122949382 | 12294938 | 15 | Type 2 diabetes mellitus |
| 122949382 | 12294938 | 16 | Urinary tract infection |
| 122949382 | 12294938 | 17 | Tonsillitis |
| 122949382 | 12294938 | 18 | Tonsillitis |
| 122949382 | 12294938 | 19 | Back pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122949382 | 12294938 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122949382 | 12294938 | Gastritis | |
| 122949382 | 12294938 | Tonsillitis | |
| 122949382 | 12294938 | Type 2 diabetes mellitus | |
| 122949382 | 12294938 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 122949382 | 12294938 | 1 | 20141001 | 0 | ||
| 122949382 | 12294938 | 3 | 20141001 | 20141028 | 0 | |
| 122949382 | 12294938 | 4 | 20141029 | 20141125 | 0 | |
| 122949382 | 12294938 | 5 | 20141126 | 20141225 | 0 | |
| 122949382 | 12294938 | 6 | 20141226 | 20150122 | 0 | |
| 122949382 | 12294938 | 7 | 20150123 | 20150222 | 0 | |
| 122949382 | 12294938 | 8 | 20150223 | 20150317 | 0 | |
| 122949382 | 12294938 | 9 | 20150318 | 0 | ||
| 122949382 | 12294938 | 10 | 20141001 | 0 | ||
| 122949382 | 12294938 | 11 | 20141005 | 0 | ||
| 122949382 | 12294938 | 12 | 20141008 | 20141016 | 0 | |
| 122949382 | 12294938 | 13 | 20150512 | 0 | ||
| 122949382 | 12294938 | 14 | 20141017 | 0 | ||
| 122949382 | 12294938 | 15 | 20150123 | 0 | ||
| 122949382 | 12294938 | 16 | 20150305 | 20150309 | 0 | |
| 122949382 | 12294938 | 17 | 20150317 | 20150324 | 0 | |
| 122949382 | 12294938 | 18 | 20150317 | 20150324 | 0 | |
| 122949382 | 12294938 | 19 | 20150512 | 20150908 | 0 |