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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124310333 | 12431033 | 3 | F | 20160711 | 20160603 | 20160713 | EXP | AR-ROCHE-1766609 | ROCHE | 0.00 | M | Y | 0.00000 | 20160713 | MD | AR | AR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124310333 | 12431033 | 1 | PS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 4 CYCLES RECEIVED AT THE MOMENT OF AE | 103705 | 700 | MG | SOLUTION FOR INFUSION | |||||||
| 124310333 | 12431033 | 2 | C | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 0 | |||||||||||
| 124310333 | 12431033 | 3 | C | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124310333 | 12431033 | 1 | Chronic lymphocytic leukaemia |
| 124310333 | 12431033 | 2 | Chronic lymphocytic leukaemia |
| 124310333 | 12431033 | 3 | Chronic lymphocytic leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124310333 | 12431033 | DE |
| 124310333 | 12431033 | HO |
| 124310333 | 12431033 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124310333 | 12431033 | Allergy to immunoglobulin therapy | |
| 124310333 | 12431033 | Anal abscess | |
| 124310333 | 12431033 | Aphthous ulcer | |
| 124310333 | 12431033 | Cytopenia | |
| 124310333 | 12431033 | Herpes zoster | |
| 124310333 | 12431033 | Hypogammaglobulinaemia | |
| 124310333 | 12431033 | Leukopenia | |
| 124310333 | 12431033 | Lung neoplasm malignant | |
| 124310333 | 12431033 | Rectal haemorrhage | |
| 124310333 | 12431033 | Respiratory tract infection | |
| 124310333 | 12431033 | Viral infection |
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 |
|---|---|---|---|---|---|---|
| 124310333 | 12431033 | 1 | 20110613 | 201111 | 0 | |
| 124310333 | 12431033 | 2 | 201106 | 201111 | 0 | |
| 124310333 | 12431033 | 3 | 201106 | 201111 | 0 |