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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127568881 | 12756888 | 1 | I | 20110614 | 20160908 | 20160917 | 20160917 | EXP | ES-TEVA-693198ACC | TEVA | 71.19 | YR | Y | 0.00000 | 20160917 | MD | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127568881 | 12756888 | 1 | PS | BENDAMUSTINE HYDROCHLORIDE. | BENDAMUSTINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | D | 22249 | 360 | MG | POWDER FOR INJECTION | |||||||
| 127568881 | 12756888 | 2 | SS | BENDAMUSTINE HYDROCHLORIDE. | BENDAMUSTINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | D | 22249 | 360 | MG | POWDER FOR INJECTION | |||||||
| 127568881 | 12756888 | 3 | SS | RITUXIMAB | RITUXIMAB | 1 | Unknown | D | 0 | 740 | MG | ||||||||
| 127568881 | 12756888 | 4 | SS | RITUXIMAB | RITUXIMAB | 1 | Unknown | D | 0 | 980 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127568881 | 12756888 | 1 | Chronic lymphocytic leukaemia |
| 127568881 | 12756888 | 3 | Chronic lymphocytic leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127568881 | 12756888 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127568881 | 12756888 | Back pain | |
| 127568881 | 12756888 | Infusion related reaction | |
| 127568881 | 12756888 | Seizure |
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 |
|---|---|---|---|---|---|---|
| 127568881 | 12756888 | 1 | 20110613 | 20110614 | 0 | |
| 127568881 | 12756888 | 2 | 20110712 | 20110713 | 0 | |
| 127568881 | 12756888 | 3 | 20110613 | 20110614 | 0 | |
| 127568881 | 12756888 | 4 | 20110712 | 20110713 | 0 |