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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125979152 | 12597915 | 2 | F | 20160615 | 20160822 | 20160727 | 20160823 | EXP | FR-ROCHE-1800391 | ROCHE | 62.00 | YR | M | Y | 0.00000 | 20160823 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125979152 | 12597915 | 1 | PS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | Y | 103705 | 694.5 | MG | SOLUTION FOR INFUSION | |||||||
| 125979152 | 12597915 | 2 | SS | LEVACT (FRANCE) | BENDAMUSTINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | Y | 0 | 334 | MG | ||||||||
| 125979152 | 12597915 | 3 | C | KARDEGIC | ASPIRIN LYSINE | 1 | 0 | ||||||||||||
| 125979152 | 12597915 | 4 | C | ZELITREX | VALACYCLOVIR HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125979152 | 12597915 | 5 | C | INEXIUM | ESOMEPRAZOLE | 1 | 0 | ||||||||||||
| 125979152 | 12597915 | 6 | C | NEURONTIN | GABAPENTIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125979152 | 12597915 | 1 | Waldenstrom's macroglobulinaemia |
| 125979152 | 12597915 | 2 | Waldenstrom's macroglobulinaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125979152 | 12597915 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125979152 | 12597915 | Acute kidney injury | |
| 125979152 | 12597915 | Drug reaction with eosinophilia and systemic symptoms | |
| 125979152 | 12597915 | Off label use | |
| 125979152 | 12597915 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 125979152 | 12597915 | 1 | 20160524 | 20160524 | 0 | |
| 125979152 | 12597915 | 2 | 20160524 | 20160525 | 0 |