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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127138521 | 12713852 | 1 | I | 20160811 | 20160901 | 20160905 | 20160905 | EXP | FR-ROCHE-1824949 | ROCHE | 76.00 | YR | F | Y | 0.00000 | 20160905 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127138521 | 12713852 | 1 | PS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | U | 103705 | 280 | MG | SOLUTION FOR INFUSION | |||||||
| 127138521 | 12713852 | 2 | SS | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | U | 0 | 1 | DF | TIW | |||||||
| 127138521 | 12713852 | 3 | SS | LEVACT (FRANCE) | BENDAMUSTINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | U | 0 | ||||||||||
| 127138521 | 12713852 | 4 | C | ZELITREX | VALACYCLOVIR HYDROCHLORIDE | 1 | Oral | 0 | 500 | MG | BID | ||||||||
| 127138521 | 12713852 | 5 | C | FASTURTEC | RASBURICASE | 1 | Intravenous (not otherwise specified) | SINGLE DOSE | 0 | 7.5 | MG | ||||||||
| 127138521 | 12713852 | 6 | C | PRIVIGEN | HUMAN IMMUNOGLOBULIN G | 1 | Unknown | SINGLE DOSE | 0 | 20 | G | ||||||||
| 127138521 | 12713852 | 7 | C | LEVOTHYROX | LEVOTHYROXINE | 1 | 0 | ||||||||||||
| 127138521 | 12713852 | 8 | C | INEXIUM | ESOMEPRAZOLE | 1 | 0 | ||||||||||||
| 127138521 | 12713852 | 9 | C | FOLINORAL | LEUCOVORIN CALCIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127138521 | 12713852 | 1 | Chronic lymphocytic leukaemia |
| 127138521 | 12713852 | 2 | Opportunistic infection prophylaxis |
| 127138521 | 12713852 | 3 | Chronic lymphocytic leukaemia |
| 127138521 | 12713852 | 4 | Opportunistic infection prophylaxis |
| 127138521 | 12713852 | 6 | Hypogammaglobulinaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127138521 | 12713852 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127138521 | 12713852 | Eosinophilia | |
| 127138521 | 12713852 | Pruritus generalised | |
| 127138521 | 12713852 | Rash maculo-papular |
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 |
|---|---|---|---|---|---|---|
| 127138521 | 12713852 | 1 | 20160718 | 20160719 | 0 | |
| 127138521 | 12713852 | 2 | 20160720 | 20160812 | 0 | |
| 127138521 | 12713852 | 3 | 20160719 | 20160720 | 0 | |
| 127138521 | 12713852 | 4 | 20160720 | 0 | ||
| 127138521 | 12713852 | 5 | 20160718 | 0 | ||
| 127138521 | 12713852 | 6 | 20160720 | 0 |