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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126005551 | 12600555 | 1 | I | 20160713 | 20160727 | 20160727 | EXP | US-APOTEX-2016AP009861 | APOTEX | 61.00 | YR | M | Y | 0.00000 | 20160727 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126005551 | 12600555 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | UNK, UNKNOWN | 90499 | TABLET | |||||||||
| 126005551 | 12600555 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | UNK, UNKNOWN | 0 | ||||||||||
| 126005551 | 12600555 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | UNK, UNKNOWN | 0 | ||||||||||
| 126005551 | 12600555 | 4 | C | RITUXIMAB | RITUXIMAB | 1 | Unknown | UNK, UNKNOWN | 0 | ||||||||||
| 126005551 | 12600555 | 5 | C | RITUXIMAB | RITUXIMAB | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126005551 | 12600555 | 1 | Immunosuppressant drug therapy |
| 126005551 | 12600555 | 2 | Immunosuppressant drug therapy |
| 126005551 | 12600555 | 3 | Immunosuppressant drug therapy |
| 126005551 | 12600555 | 4 | Kidney transplant rejection |
| 126005551 | 12600555 | 5 | Epstein-Barr viraemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126005551 | 12600555 | DE |
| 126005551 | 12600555 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126005551 | 12600555 | Bacteraemia | |
| 126005551 | 12600555 | Plasma cell myeloma | |
| 126005551 | 12600555 | Post transplant lymphoproliferative disorder | |
| 126005551 | 12600555 | Staphylococcal infection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |