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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125740352 | 12574035 | 2 | F | 20160713 | 20160720 | 20160725 | EXP | US-JNJFOC-20160711195 | JANSSEN | JOHNSTON PB, LAPLANT B, MCPHAIL E, HABERMANN TM, INWARDS DJ, MICALLEF IN, ET AL. EVEROLIMUS COMBINED WITH R-CHOP-21 FOR NEW, UNTREATED, DIFFUSE LARGE B-CELL LYMPHOMA (NCCTG 1085 [ALLIANCE]): SAFETY AND EFFICACY RESULTS OF A PHASE 1 AND FEASIBILITY TRIAL. THE LANCET HAEMATOLOGY JUL-2016;3 (7):E309-16. | 0.00 | Y | 0.00000 | 20160725 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125740352 | 12574035 | 1 | PS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | U | U | 50718 | 50 | MG/M**2 | LIPOSOME INJECTION | ||||||
| 125740352 | 12574035 | 2 | SS | RITUXIMAB | RITUXIMAB | 1 | Intravenous (not otherwise specified) | U | 0 | 375 | MG/M**2 | UNSPECIFIED | |||||||
| 125740352 | 12574035 | 3 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | U | 0 | 750 | MG/M**2 | UNSPECIFIED | |||||||
| 125740352 | 12574035 | 4 | SS | VINCRISTINE | VINCRISTINE | 1 | Intravenous (not otherwise specified) | U | 0 | 1.4 | MG/M**2 | UNSPECIFIED | |||||||
| 125740352 | 12574035 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | U | 0 | 100 | MG/M**2 | UNSPECIFIED | |||||||
| 125740352 | 12574035 | 6 | SS | EVEROLIMUS | EVEROLIMUS | 1 | Oral | 0 | 10 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125740352 | 12574035 | 1 | Diffuse large B-cell lymphoma |
| 125740352 | 12574035 | 2 | Diffuse large B-cell lymphoma |
| 125740352 | 12574035 | 3 | Diffuse large B-cell lymphoma |
| 125740352 | 12574035 | 4 | Diffuse large B-cell lymphoma |
| 125740352 | 12574035 | 5 | Diffuse large B-cell lymphoma |
| 125740352 | 12574035 | 6 | Diffuse large B-cell lymphoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125740352 | 12574035 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125740352 | 12574035 | Alopecia | |
| 125740352 | 12574035 | Anaemia | |
| 125740352 | 12574035 | Dermatitis acneiform | |
| 125740352 | 12574035 | Diarrhoea | |
| 125740352 | 12574035 | Dry skin | |
| 125740352 | 12574035 | Embolism | |
| 125740352 | 12574035 | Fatigue | |
| 125740352 | 12574035 | Febrile neutropenia | |
| 125740352 | 12574035 | Hypercholesterolaemia | |
| 125740352 | 12574035 | Hyperglycaemia | |
| 125740352 | 12574035 | Hypertriglyceridaemia | |
| 125740352 | 12574035 | Hypocalcaemia | |
| 125740352 | 12574035 | Hyponatraemia | |
| 125740352 | 12574035 | Hypophosphataemia | |
| 125740352 | 12574035 | Hypoxia | |
| 125740352 | 12574035 | Leukocytosis | |
| 125740352 | 12574035 | Leukopenia | |
| 125740352 | 12574035 | Lung infection | |
| 125740352 | 12574035 | Lymphopenia | |
| 125740352 | 12574035 | Nausea | |
| 125740352 | 12574035 | Neutropenia | |
| 125740352 | 12574035 | Pneumonitis | |
| 125740352 | 12574035 | Rash maculo-papular | |
| 125740352 | 12574035 | Seizure | |
| 125740352 | 12574035 | Sepsis | |
| 125740352 | 12574035 | Thrombocytopenia | |
| 125740352 | 12574035 | Urinary tract infection | |
| 125740352 | 12574035 | Weight decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |