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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125274531 | 12527453 | 1 | I | 20141204 | 20160628 | 20160705 | 20160705 | EXP | FR-ASTELLAS-2016US025338 | ASTELLAS | 45.57 | YR | F | Y | 0.00000 | 20160705 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125274531 | 12527453 | 1 | PS | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Oral | UNK UNK, UNKNOWN FREQ. | 50708 | FORMULATION UNKNOWN | |||||||||
| 125274531 | 12527453 | 2 | SS | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Oral | U | 50708 | 1.5 | MG | FORMULATION UNKNOWN | BID | ||||||
| 125274531 | 12527453 | 3 | SS | IMUREL /00001501/ | AZATHIOPRINE SODIUM | 1 | Oral | 0 | 50 | MG | FORMULATION UNKNOWN | ||||||||
| 125274531 | 12527453 | 4 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | 5 | MG | FORMULATION UNKNOWN | |||||||
| 125274531 | 12527453 | 5 | C | SECTRAL | ACEBUTOLOL HYDROCHLORIDE | 1 | Unknown | U | 0 | 200 | MG | FORMULATION UNKNOWN | |||||||
| 125274531 | 12527453 | 6 | C | AMLOR | AMLODIPINE BESYLATE | 1 | Unknown | U | 0 | 5 | MG | FORMULATION UNKNOWN | |||||||
| 125274531 | 12527453 | 7 | C | BICARBONATE | BICARBONATE ION | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125274531 | 12527453 | 1 | Renal and pancreas transplant |
| 125274531 | 12527453 | 3 | Renal and pancreas transplant |
| 125274531 | 12527453 | 4 | Product used for unknown indication |
| 125274531 | 12527453 | 5 | Product used for unknown indication |
| 125274531 | 12527453 | 6 | Product used for unknown indication |
| 125274531 | 12527453 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125274531 | 12527453 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125274531 | 12527453 | Metabolic encephalopathy | |
| 125274531 | 12527453 | Off label use | |
| 125274531 | 12527453 | Pancytopenia | |
| 125274531 | 12527453 | Peliosis hepatis |
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 |
|---|---|---|---|---|---|---|
| 125274531 | 12527453 | 3 | 20141204 | 0 |