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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125433171 | 12543317 | 1 | I | 20160701 | 20160711 | 20160711 | EXP | AU-ROCHE-1788620 | ROCHE | 0.00 | F | Y | 0.00000 | 20160711 | MD | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125433171 | 12543317 | 1 | PS | MABTHERA | RITUXIMAB | 1 | Unknown | START: 2 YEARS AGO | U | 103705 | |||||||||
| 125433171 | 12543317 | 2 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | U | 50722 | ||||||||||
| 125433171 | 12543317 | 3 | C | CYCLOSPORINE. | CYCLOSPORINE | 1 | 0 | ||||||||||||
| 125433171 | 12543317 | 4 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 0 | 60 | MG | QD | ||||||||
| 125433171 | 12543317 | 5 | C | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125433171 | 12543317 | 1 | Dermatomyositis |
| 125433171 | 12543317 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125433171 | 12543317 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125433171 | 12543317 | Blood creatine phosphokinase increased | |
| 125433171 | 12543317 | Off label use | |
| 125433171 | 12543317 | Respiratory failure | |
| 125433171 | 12543317 | Skin disorder |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |