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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 80996983 | 8099698 | 3 | F | 20160530 | 20120911 | 20160711 | EXP | DE-CELGENEUS-062-21880-11081370 | CELGENE | KRONKE J, KUCHENBAUER F, KULL M, TELEANU V, BULLINGER L, BUNJES D. IKZF1 EXPRESSION IS A PROGNOSTIC MARKER IN NEWLY DIAGNOSED MULTIPLE MYELOMA TREATED WITH LENALIDOMIDE IN COMBINATION WITH INTENSIVE CHEMOTHERAPY: RESULTS OF THE GERMAN MYELOMA STUDY GROUP (DSMM).. | 0.00 | Y | 0.00000 | 20160711 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 80996983 | 8099698 | 1 | PS | REVLIMID | LENALIDOMIDE | 1 | Oral | 25 MILLIGRAM | U | 21880 | 25 | MG | CAPSULES | ||||||
| 80996983 | 8099698 | 2 | SS | ADRIAMYCIN | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | U | 0 | 9 | MG/M**2 | UNKNOWN | |||||||
| 80996983 | 8099698 | 3 | SS | ADRIAMYCIN | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | U | 0 | 9 | MG/M**2 | UNKNOWN | |||||||
| 80996983 | 8099698 | 4 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | U | 0 | 40 | MG | UNKNOWN | |||||||
| 80996983 | 8099698 | 5 | C | Melphalan | MELPHALAN | 1 | Unknown | 0 | 200 | MG/M**2 | UNKNOWN | ||||||||
| 80996983 | 8099698 | 6 | C | HEPARIN | HEPARIN SODIUM | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 80996983 | 8099698 | 7 | C | PEGFILGRASTIM | PEGFILGRASTIM | 1 | Unknown | 40 MILLIGRAM | 0 | 6 | MG | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 80996983 | 8099698 | 1 | Plasma cell myeloma |
| 80996983 | 8099698 | 2 | Plasma cell myeloma |
| 80996983 | 8099698 | 4 | Plasma cell myeloma |
| 80996983 | 8099698 | 5 | Plasma cell myeloma |
| 80996983 | 8099698 | 6 | Thrombosis prophylaxis |
| 80996983 | 8099698 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 80996983 | 8099698 | DE |
| 80996983 | 8099698 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 80996983 | 8099698 | Adverse event | |
| 80996983 | 8099698 | Anaemia | |
| 80996983 | 8099698 | Arrhythmia | |
| 80996983 | 8099698 | Atrial fibrillation | |
| 80996983 | 8099698 | Back pain | |
| 80996983 | 8099698 | Bone pain | |
| 80996983 | 8099698 | Constipation | |
| 80996983 | 8099698 | Cough | |
| 80996983 | 8099698 | Death | |
| 80996983 | 8099698 | Diarrhoea | |
| 80996983 | 8099698 | Dry skin | |
| 80996983 | 8099698 | Embolism venous | |
| 80996983 | 8099698 | Fatigue | |
| 80996983 | 8099698 | Febrile neutropenia | |
| 80996983 | 8099698 | Graft versus host disease | |
| 80996983 | 8099698 | Haematotoxicity | |
| 80996983 | 8099698 | Headache | |
| 80996983 | 8099698 | Herpes zoster | |
| 80996983 | 8099698 | Hyperglycaemia | |
| 80996983 | 8099698 | Infection | |
| 80996983 | 8099698 | Influenza like illness | |
| 80996983 | 8099698 | Leukopenia | |
| 80996983 | 8099698 | Muscle spasms | |
| 80996983 | 8099698 | Myocardial infarction | |
| 80996983 | 8099698 | Nasopharyngitis | |
| 80996983 | 8099698 | Nausea | |
| 80996983 | 8099698 | Neutropenia | |
| 80996983 | 8099698 | Peripheral sensory neuropathy | |
| 80996983 | 8099698 | Plasma cell myeloma | |
| 80996983 | 8099698 | Pneumonia | |
| 80996983 | 8099698 | Polyneuropathy | |
| 80996983 | 8099698 | Pruritus | |
| 80996983 | 8099698 | Pulmonary embolism | |
| 80996983 | 8099698 | Pyrexia | |
| 80996983 | 8099698 | Rash | |
| 80996983 | 8099698 | Respiratory tract infection | |
| 80996983 | 8099698 | Second primary malignancy | |
| 80996983 | 8099698 | Sepsis | |
| 80996983 | 8099698 | Subclavian vein thrombosis | |
| 80996983 | 8099698 | Thrombocytopenia | |
| 80996983 | 8099698 | Thrombotic microangiopathy | |
| 80996983 | 8099698 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |