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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126456161 | 12645616 | 1 | I | 20160809 | 20160811 | 20160811 | EXP | SA-JNJFOC-20160807103 | JANSSEN | ALWASAIDI TA, HAMADAH A, ALTOURI S, TAY J, MCDIARMID S, FAUGHT C, ET AL. OUTCOMES OF BOTH ABBREVIATED HYPER-CVAD INDUCTION FOLLOWED BY AUTOLOGOUS HEMATOPOIETIC CELL TRANSPLANTATION AND CONVENTIONAL CHEMOTHERAPY FOR MANTLE CELL LYMPHOMA: A 10-YEAR SINGLE-CENTRE EXPERIENCE WITH LITERATURE REVIEW. CANCER MEDICINE 2015;4/12:1817-1827. | 0.00 | Y | 0.00000 | 20160811 | OT | SA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126456161 | 12645616 | 1 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | UNDER R-CHOP THERAPY (6-8 CYCLES) | U | U | 0 | 50 | MG/M**2 | LIPOSOME INJECTION | |||||
| 126456161 | 12645616 | 2 | PS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | UNDER HYPER-CVAD THERAPY | U | U | 50718 | 50 | MG/M**2 | LIPOSOME INJECTION | |||||
| 126456161 | 12645616 | 3 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | U | 0 | 750 | MG/M**2 | UNSPECIFIED | |||||||
| 126456161 | 12645616 | 4 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | U | 0 | 300 | MG/M**2 | UNSPECIFIED | Q12H | ||||||
| 126456161 | 12645616 | 5 | SS | VINCRISTINE | VINCRISTINE | 1 | Unknown | U | 0 | 2 | MG | UNSPECIFIED | |||||||
| 126456161 | 12645616 | 6 | SS | VINCRISTINE | VINCRISTINE | 1 | Unknown | R-CHOP (6 TO 8 CYCLES) | U | 0 | 2 | MG | UNSPECIFIED | ||||||
| 126456161 | 12645616 | 7 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | U | 0 | 40 | MG | UNSPECIFIED | |||||||
| 126456161 | 12645616 | 8 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 1 G/M2 | U | 0 | UNSPECIFIED | ||||||||
| 126456161 | 12645616 | 9 | SS | CYTARABINE. | CYTARABINE | 1 | Unknown | 3 G/M2 | U | 0 | UNSPECIFIED | ||||||||
| 126456161 | 12645616 | 10 | SS | RITUXIMAB | RITUXIMAB | 1 | Unknown | U | 0 | 375 | MG/M**2 | UNSPECIFIED | |||||||
| 126456161 | 12645616 | 11 | SS | RITUXIMAB | RITUXIMAB | 1 | Unknown | R-CHOP THERAPY (6 TO 8 CYCLES) | U | 0 | 375 | MG/M**2 | UNSPECIFIED | ||||||
| 126456161 | 12645616 | 12 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 6 TO 8 CYCLES | U | 0 | 100 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126456161 | 12645616 | 1 | Mantle cell lymphoma |
| 126456161 | 12645616 | 2 | Mantle cell lymphoma |
| 126456161 | 12645616 | 3 | Mantle cell lymphoma |
| 126456161 | 12645616 | 4 | Mantle cell lymphoma |
| 126456161 | 12645616 | 5 | Mantle cell lymphoma |
| 126456161 | 12645616 | 6 | Mantle cell lymphoma |
| 126456161 | 12645616 | 7 | Mantle cell lymphoma |
| 126456161 | 12645616 | 8 | Mantle cell lymphoma |
| 126456161 | 12645616 | 9 | Mantle cell lymphoma |
| 126456161 | 12645616 | 10 | Mantle cell lymphoma |
| 126456161 | 12645616 | 11 | Mantle cell lymphoma |
| 126456161 | 12645616 | 12 | Mantle cell lymphoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126456161 | 12645616 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126456161 | 12645616 | Cardiac failure | |
| 126456161 | 12645616 | Gastrointestinal haemorrhage | |
| 126456161 | 12645616 | Gastrointestinal perforation | |
| 126456161 | 12645616 | Myocardial infarction | |
| 126456161 | 12645616 | Neutropenic sepsis | |
| 126456161 | 12645616 | Off label use | |
| 126456161 | 12645616 | Product use issue | |
| 126456161 | 12645616 | Sepsis | |
| 126456161 | 12645616 | Septic shock | |
| 126456161 | 12645616 | Status epilepticus | |
| 126456161 | 12645616 | Systemic candida |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |