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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126107611 | 12610761 | 1 | I | 20160719 | 20160801 | 20160801 | EXP | JP-JNJFOC-20160718379 | JANSSEN | MURAYAMA T, FUKUDA T, OKUMURA H, SUNAMI K, SAWAZAKI A, MAEDA Y, ET AL. EFFICACY OF UPFRONT HIGH DOSE CHEMOTHERAPY PLUS RITUXIMAB FOLLOWED BY AUTOLOGOUS PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR UNTREATED HIGH INTERMEDIATE, AND HIGH RISK DIFFUSE LARGE B-CELL LYMPHOMA. A MULTICENTER PROSPECTIVE PHASE II STUDY (JSCT-N. INT J HEMATOL 01-JUN-2016;103 (6):676-685. | 0.00 | A | Y | 0.00000 | 20160801 | OT | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126107611 | 12610761 | 1 | PS | DOXORUBICIN | DOXORUBICIN | 1 | Unknown | Y | U | 50718 | 50 | MG/M**2 | LIPOSOME INJECTION | ||||||
| 126107611 | 12610761 | 2 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | Y | 0 | 50 | MG/KG | UNSPECIFIED | |||||||
| 126107611 | 12610761 | 3 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | Y | 0 | 750 | MG/M**2 | UNSPECIFIED | |||||||
| 126107611 | 12610761 | 4 | SS | VINCRISTINE | VINCRISTINE | 1 | Unknown | Y | 0 | 1.4 | MG/M**2 | UNSPECIFIED | |||||||
| 126107611 | 12610761 | 5 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | Y | 0 | 100 | MG | UNSPECIFIED | |||||||
| 126107611 | 12610761 | 6 | SS | RITUXIMAB | RITUXIMAB | 1 | Unknown | Y | 0 | UNSPECIFIED | |||||||||
| 126107611 | 12610761 | 7 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | Y | 0 | 500 | MG/M**2 | UNSPECIFIED | |||||||
| 126107611 | 12610761 | 8 | C | G-CSF | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | Unknown | 0 | 600 | UG | UNSPECIFIED | ||||||||
| 126107611 | 12610761 | 9 | C | RANIMUSTINE | RANIMUSTINE | 1 | Unknown | 0 | 200 | MG/M**2 | UNSPECIFIED | ||||||||
| 126107611 | 12610761 | 10 | C | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | 0 | 300 | MG/M**2 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126107611 | 12610761 | 1 | Diffuse large B-cell lymphoma |
| 126107611 | 12610761 | 2 | Diffuse large B-cell lymphoma |
| 126107611 | 12610761 | 3 | Diffuse large B-cell lymphoma |
| 126107611 | 12610761 | 4 | Diffuse large B-cell lymphoma |
| 126107611 | 12610761 | 5 | Diffuse large B-cell lymphoma |
| 126107611 | 12610761 | 6 | Diffuse large B-cell lymphoma |
| 126107611 | 12610761 | 7 | Diffuse large B-cell lymphoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126107611 | 12610761 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126107611 | 12610761 | Abdominal pain | |
| 126107611 | 12610761 | Adrenal disorder | |
| 126107611 | 12610761 | Alanine aminotransferase increased | |
| 126107611 | 12610761 | Aspartate aminotransferase increased | |
| 126107611 | 12610761 | Bacterial infection | |
| 126107611 | 12610761 | Blood bilirubin increased | |
| 126107611 | 12610761 | Cystitis haemorrhagic | |
| 126107611 | 12610761 | Deep vein thrombosis | |
| 126107611 | 12610761 | Dermatitis | |
| 126107611 | 12610761 | Device related infection | |
| 126107611 | 12610761 | Diabetes mellitus | |
| 126107611 | 12610761 | Diarrhoea | |
| 126107611 | 12610761 | Enterovesical fistula | |
| 126107611 | 12610761 | Febrile neutropenia | |
| 126107611 | 12610761 | Gastric varices | |
| 126107611 | 12610761 | Gingivitis | |
| 126107611 | 12610761 | Herpes zoster | |
| 126107611 | 12610761 | Hypertension | |
| 126107611 | 12610761 | Hypotension | |
| 126107611 | 12610761 | Hypoxia | |
| 126107611 | 12610761 | Infection | |
| 126107611 | 12610761 | Liver disorder | |
| 126107611 | 12610761 | Lung disorder | |
| 126107611 | 12610761 | Nausea | |
| 126107611 | 12610761 | Neuropathy peripheral | |
| 126107611 | 12610761 | Rash | |
| 126107611 | 12610761 | Skin disorder | |
| 126107611 | 12610761 | Stomatitis | |
| 126107611 | 12610761 | Tachycardia | |
| 126107611 | 12610761 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |