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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125190482 | 12519048 | 2 | F | 20151221 | 20160711 | 20160701 | 20160714 | EXP | PL-ROCHE-1783041 | ROCHE | 10.10 | YR | F | Y | 52.50000 | KG | 20160714 | MD | PL | PL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125190482 | 12519048 | 1 | PS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 500 MG X 2 | Y | U | 103705 | 500 | MG | SOLUTION FOR INFUSION | |||||
| 125190482 | 12519048 | 2 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | 0 | 500 | MG | |||||||||
| 125190482 | 12519048 | 3 | C | TRITACE | RAMIPRIL | 1 | Oral | 0 | 2.5 | MG | QD | ||||||||
| 125190482 | 12519048 | 4 | C | ENCORTON | PREDNISONE | 1 | Oral | VARIABLE DOSES | 0 | 5 | MG | QD | |||||||
| 125190482 | 12519048 | 5 | C | RANIGAST | 2 | Oral | 0 | 75 | MG | BID | |||||||||
| 125190482 | 12519048 | 6 | C | ZOCOR | SIMVASTATIN | 1 | Oral | 0 | 10 | MG | QD | ||||||||
| 125190482 | 12519048 | 7 | C | CALPEROS | CALCIUM CARBONATE | 1 | Unknown | 1X1G, VARIABLE DOSES | 0 | ||||||||||
| 125190482 | 12519048 | 8 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Unknown | 1 X 3 DROPS, 1 X 2-3 CAPSULES | 0 | ||||||||||
| 125190482 | 12519048 | 9 | C | CYCLOSPORINE. | CYCLOSPORINE | 1 | 0 | ||||||||||||
| 125190482 | 12519048 | 10 | C | CYCLAID | CYCLOSPORINE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125190482 | 12519048 | 1 | Nephrotic syndrome |
| 125190482 | 12519048 | 2 | Nephrotic syndrome |
| 125190482 | 12519048 | 3 | Nephrotic syndrome |
| 125190482 | 12519048 | 4 | Nephrotic syndrome |
| 125190482 | 12519048 | 6 | Dyslipidaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125190482 | 12519048 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125190482 | 12519048 | Alopecia | |
| 125190482 | 12519048 | B-lymphocyte count decreased | |
| 125190482 | 12519048 | Drug interaction | |
| 125190482 | 12519048 | Eosinophil count increased | |
| 125190482 | 12519048 | Monocyte count increased | |
| 125190482 | 12519048 | Off label use | |
| 125190482 | 12519048 | T-lymphocyte count increased |
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 |
|---|---|---|---|---|---|---|
| 125190482 | 12519048 | 1 | 20151204 | 20160322 | 0 | |
| 125190482 | 12519048 | 2 | 201407 | 201512 | 0 | |
| 125190482 | 12519048 | 3 | 201503 | 0 | ||
| 125190482 | 12519048 | 4 | 2008 | 0 | ||
| 125190482 | 12519048 | 5 | 2008 | 201603 | 0 | |
| 125190482 | 12519048 | 6 | 201511 | 201601 | 0 | |
| 125190482 | 12519048 | 7 | 2008 | 201603 | 0 | |
| 125190482 | 12519048 | 8 | 2008 | 201603 | 0 |