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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124389902 | 12438990 | 2 | F | 20160409 | 20160624 | 20160606 | 20160707 | EXP | DK-DKMA-WBS-0003543 | DK-ROCHE-1769488 | ROCHE | 81.50 | YR | M | Y | 0.00000 | 20160707 | MD | DK | DK |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124389902 | 12438990 | 1 | PS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | N | U | N7073B10 | 103705 | 900 | MG | SOLUTION FOR INFUSION | |||||
| 124389902 | 12438990 | 2 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | CYCLE 4 | N | U | N7073B10 | 103705 | SOLUTION FOR INFUSION | ||||||
| 124389902 | 12438990 | 3 | SS | BENDAMUSTINE | BENDAMUSTINE | 1 | Intravenous (not otherwise specified) | N | U | HS1029,HS0800 | 0 | 125 | MG | ||||||
| 124389902 | 12438990 | 4 | SS | BENDAMUSTINE | BENDAMUSTINE | 1 | Intravenous (not otherwise specified) | N | U | HS1029,HS0800 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124389902 | 12438990 | 1 | Chronic lymphocytic leukaemia |
| 124389902 | 12438990 | 2 | Blood immunoglobulin G |
| 124389902 | 12438990 | 3 | Chronic lymphocytic leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124389902 | 12438990 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124389902 | 12438990 | JC virus test positive | |
| 124389902 | 12438990 | Muscular weakness | |
| 124389902 | 12438990 | Progressive multifocal leukoencephalopathy | |
| 124389902 | 12438990 | Speech disorder |
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 |
|---|---|---|---|---|---|---|
| 124389902 | 12438990 | 1 | 20160203 | 0 | ||
| 124389902 | 12438990 | 2 | 20160202 | 20160419 | 0 | |
| 124389902 | 12438990 | 3 | 20160104 | 20160419 | 0 | |
| 124389902 | 12438990 | 4 | 20151229 | 0 |