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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125585682 | 12558568 | 2 | F | 20160719 | 20160714 | 20160725 | EXP | PHJP2016JP019665 | NOVARTIS | 62.00 | YR | M | Y | 0.00000 | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125585682 | 12558568 | 1 | PS | NEORAL | CYCLOSPORINE | 1 | Oral | 50 MG, QD | 50715 | 50 | MG | CAPSULE | QD | ||||||
| 125585682 | 12558568 | 2 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | 200 MG, UNK | 50715 | 200 | MG | CAPSULE | |||||||
| 125585682 | 12558568 | 3 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125585682 | 12558568 | 1 | Interstitial lung disease |
| 125585682 | 12558568 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125585682 | 12558568 | HO |
| 125585682 | 12558568 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125585682 | 12558568 | Femur fracture | |
| 125585682 | 12558568 | Osteonecrosis | |
| 125585682 | 12558568 | Product use issue |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |