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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126911651 | 12691165 | 1 | I | 20160816 | 20160826 | 20160826 | EXP | FR-JNJFOC-20160815268 | JANSSEN | ANDREWS A. ARA-C SHOULD BE PART OF CONDITIONING REGIMEN IN YOUNG PATIENTS WITH MANTLE-CELL LYMPHOMA. AMERICAN HEALTH + DRUG BENEFITS 2013;6/1. HERMINE O, HOSTER E, WALEWSKI J, BOSLY A, STILGENBAUER S, THIEBLEMONT C, ET AL. ADDITION OF HIGH-DOSE CYTARABINE TO IMMUNOCHEMOTHERAPY BEFORE AUTOLOGOUS STEM-CELL TRANSPLANTATION IN PATIENTS AGED 65 YEARS OR YOUNGER WITH MANTLE CELL LYMPHOMA (MCL YOUNGER): A RANDOMISED, OPENLABEL PHASE 3 TRIAL OF THE EUROPEAN MANTLE CELL LYMPHOM. LANCET 06-AUG-2016;388/10 | 0.00 | Y | 0.00000 | 20160826 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126911651 | 12691165 | 1 | PS | DOXORUBICIN | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | N | 50718 | 50 | MG/M**2 | LIPOSOME INJECTION | |||||||
| 126911651 | 12691165 | 2 | SS | RITUXIMAB | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 0 | 375 | MG/M**2 | UNSPECIFIED | ||||||||
| 126911651 | 12691165 | 3 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 0 | 750 | MG/M**2 | UNSPECIFIED | ||||||||
| 126911651 | 12691165 | 4 | SS | VINCRISTINE | VINCRISTINE | 1 | Intravenous (not otherwise specified) | MAXIMUN 2.0MG | 0 | 1.4 | MG/M**2 | UNSPECIFIED | |||||||
| 126911651 | 12691165 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | DAY 1-5 , EVERY 3 WEEKS | 0 | 100 | MG | UNSPECIFIED | |||||||
| 126911651 | 12691165 | 6 | SS | ARA-C | CYTARABINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 126911651 | 12691165 | 7 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | DAYS 1-4 | 0 | 40 | MG | UNSPECIFIED | |||||||
| 126911651 | 12691165 | 8 | SS | CYTARABINE. | CYTARABINE | 1 | Intravenous (not otherwise specified) | 2G/M2 EVERY 12 HOUR ON DAY 2 | 0 | UNSPECIFIED | |||||||||
| 126911651 | 12691165 | 9 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | CONTINUOS INFUSION OVER 24 HOURS EVERY 3 WEEKS | 0 | 100 | MG/M**2 | UNSPECIFIED | |||||||
| 126911651 | 12691165 | 10 | SS | RADIOTHERAPY | RADIATION THERAPY | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126911651 | 12691165 | 1 | Mantle cell lymphoma |
| 126911651 | 12691165 | 2 | Mantle cell lymphoma |
| 126911651 | 12691165 | 3 | Mantle cell lymphoma |
| 126911651 | 12691165 | 4 | Mantle cell lymphoma |
| 126911651 | 12691165 | 5 | Mantle cell lymphoma |
| 126911651 | 12691165 | 6 | Mantle cell lymphoma |
| 126911651 | 12691165 | 7 | Mantle cell lymphoma |
| 126911651 | 12691165 | 8 | Mantle cell lymphoma |
| 126911651 | 12691165 | 9 | Mantle cell lymphoma |
| 126911651 | 12691165 | 10 | Mantle cell lymphoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126911651 | 12691165 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126911651 | 12691165 | Alopecia | |
| 126911651 | 12691165 | Arrhythmia | |
| 126911651 | 12691165 | Arthralgia | |
| 126911651 | 12691165 | Blood bilirubin abnormal | |
| 126911651 | 12691165 | Blood creatinine abnormal | |
| 126911651 | 12691165 | Bone marrow failure | |
| 126911651 | 12691165 | Cardiotoxicity | |
| 126911651 | 12691165 | Constipation | |
| 126911651 | 12691165 | Depression | |
| 126911651 | 12691165 | Diarrhoea | |
| 126911651 | 12691165 | Fatigue | |
| 126911651 | 12691165 | Febrile neutropenia | |
| 126911651 | 12691165 | Granulocytes abnormal | |
| 126911651 | 12691165 | Haematuria | |
| 126911651 | 12691165 | Haemoglobin abnormal | |
| 126911651 | 12691165 | Haemorrhage | |
| 126911651 | 12691165 | Hypersensitivity | |
| 126911651 | 12691165 | Infection | |
| 126911651 | 12691165 | Lymphocyte count abnormal | |
| 126911651 | 12691165 | Mantle cell lymphoma recurrent | |
| 126911651 | 12691165 | Mucosal inflammation | |
| 126911651 | 12691165 | Myalgia | |
| 126911651 | 12691165 | Nausea | |
| 126911651 | 12691165 | Neuropathy peripheral | |
| 126911651 | 12691165 | Platelet disorder | |
| 126911651 | 12691165 | Pulmonary toxicity | |
| 126911651 | 12691165 | Transaminases abnormal | |
| 126911651 | 12691165 | Treatment failure | |
| 126911651 | 12691165 | Vomiting | |
| 126911651 | 12691165 | Weight decreased | |
| 126911651 | 12691165 | White blood cell disorder |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |