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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126487391 | 12648739 | 1 | I | 20160809 | 20160812 | 20160812 | EXP | FR-JNJFOC-20160808849 | JANSSEN | RIBRAG V, KOSCIELNY S, BOSQ J, LEGUAY T, CASASNOVAS O, FORNECKER L, ET AL. RITUXIMAB AND DOSE-DENSE CHEMOTHERAPY FOR ADULTS WITH BURKITT^S LYMPHOMA: A RANDOMISED, CONTROLLED, OPEN-LABEL, PHASE 3 TRIAL. LANCET 2016;387 (10036):2402-11. | 0.00 | Y | 0.00000 | 20160812 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126487391 | 12648739 | 1 | PS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | ON DAY 6 WITH RITUXIMAB | U | U | 50718 | LIPOSOME INJECTION | |||||||
| 126487391 | 12648739 | 2 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | ON DAY 6 WITH RITUXIMAB | U | 0 | 300 | MG/M**2 | UNSPECIFIED | ||||||
| 126487391 | 12648739 | 3 | SS | VINCRISTINE | VINCRISTINE | 1 | Unknown | 1 MG/M2 OR MAXIMUM 2 MG AND ON DAY 6 WITH RITUXIMAB | U | 0 | UNSPECIFIED | ||||||||
| 126487391 | 12648739 | 4 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | DAYS 1-7 | U | 0 | 60 | MG/M**2 | UNSPECIFIED | ||||||
| 126487391 | 12648739 | 5 | SS | RITUXIMAB | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 375 MG/M2 OR MAXIMUM 80MG ON DAY 1. | U | 0 | INJECTION | ||||||||
| 126487391 | 12648739 | 6 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | ON DAY 6 WITH RITUXIMAB | U | 0 | 8000 | MG/M**2 | UNSPECIFIED | ||||||
| 126487391 | 12648739 | 7 | SS | CYTARABINE. | CYTARABINE | 1 | Unknown | ON DAY 6 WITH RITUXIMAB | U | 0 | UNSPECIFIED | ||||||||
| 126487391 | 12648739 | 8 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | ON DAY 6 WITH RITUXIMAB | U | 0 | UNSPECIFIED | ||||||||
| 126487391 | 12648739 | 9 | SS | HYDROCORTISONE. | HYDROCORTISONE | 1 | Unknown | ON DAY 6 WITH RITUXIMAB | U | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126487391 | 12648739 | 1 | Burkitt's lymphoma |
| 126487391 | 12648739 | 2 | Burkitt's lymphoma |
| 126487391 | 12648739 | 3 | Burkitt's lymphoma |
| 126487391 | 12648739 | 4 | Burkitt's lymphoma |
| 126487391 | 12648739 | 5 | Burkitt's lymphoma |
| 126487391 | 12648739 | 6 | Burkitt's lymphoma |
| 126487391 | 12648739 | 7 | Burkitt's lymphoma |
| 126487391 | 12648739 | 8 | Burkitt's lymphoma |
| 126487391 | 12648739 | 9 | Burkitt's lymphoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126487391 | 12648739 | OT |
| 126487391 | 12648739 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126487391 | 12648739 | Cardiotoxicity | |
| 126487391 | 12648739 | Death | |
| 126487391 | 12648739 | Diarrhoea | |
| 126487391 | 12648739 | Hepatotoxicity | |
| 126487391 | 12648739 | Infection | |
| 126487391 | 12648739 | Mucosal inflammation | |
| 126487391 | 12648739 | Nephropathy toxic | |
| 126487391 | 12648739 | Neuropathy peripheral | |
| 126487391 | 12648739 | Neutropenia | |
| 126487391 | 12648739 | Pulmonary toxicity | |
| 126487391 | 12648739 | Pyrexia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |