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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122262104 | 12226210 | 4 | F | 201401 | 20160831 | 20160331 | 20160906 | EXP | JP-ASTELLAS-2016JP003904AA | ASTELLAS | 36.08 | YR | F | Y | 56.00000 | KG | 20160906 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122262104 | 12226210 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 50708 | 3 | MG | CAPSULE | QD | |||||||
| 122262104 | 12226210 | 2 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | U | 0 | 10 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122262104 | 12226210 | 1 | Systemic lupus erythematosus |
| 122262104 | 12226210 | 2 | Systemic lupus erythematosus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122262104 | 12226210 | HO |
| 122262104 | 12226210 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122262104 | 12226210 | Maternal exposure during pregnancy | |
| 122262104 | 12226210 | Off label use | |
| 122262104 | 12226210 | Premature delivery | |
| 122262104 | 12226210 | Preterm premature rupture of membranes |
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 |
|---|---|---|---|---|---|---|
| 122262104 | 12226210 | 1 | 201401 | 0 | ||
| 122262104 | 12226210 | 2 | 200103 | 0 |