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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126495021 | 12649502 | 1 | I | 20131114 | 20160812 | 20160812 | EXP | US-CELGENEUS-163-50794-13113108 | CELGENE | PERA B. COMBINATORIAL EPIGENETIC THERAPY IN DIFFUSE LARGE B CELL LYMPHOMA PRE PRECLINICAL. CLINICAL EPIGENETICS. 2016;8:79:. | 0.00 | Y | 0.00000 | 20160812 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126495021 | 12649502 | 1 | PS | VIDAZA | AZACITIDINE | 1 | Subcutaneous | U | 50794 | 55 | MG/M**2 | INJECTION | |||||||
| 126495021 | 12649502 | 2 | SS | VIDAZA | AZACITIDINE | 1 | Subcutaneous | U | 50794 | 75 | MG/M**2 | INJECTION | |||||||
| 126495021 | 12649502 | 3 | SS | VORINOSTAT | VORINOSTAT | 1 | Oral | U | 0 | 300 | MG | UNKNOWN | |||||||
| 126495021 | 12649502 | 4 | SS | VORINOSTAT | VORINOSTAT | 1 | Oral | U | 0 | 200 | MG | UNKNOWN | |||||||
| 126495021 | 12649502 | 5 | SS | VORINOSTAT | VORINOSTAT | 1 | Oral | U | 0 | 300 | MG | UNKNOWN | |||||||
| 126495021 | 12649502 | 6 | SS | VORINOSTAT | VORINOSTAT | 1 | Oral | U | 0 | 200 | MG | UNKNOWN | |||||||
| 126495021 | 12649502 | 7 | C | BENDAMUSTINE | BENDAMUSTINE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 126495021 | 12649502 | 8 | C | BRENTUXIMAB VEDOTIN | BRENTUXIMAB VEDOTIN | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 126495021 | 12649502 | 9 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 126495021 | 12649502 | 10 | C | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 126495021 | 12649502 | 11 | C | PROCARBAZINE | PROCARBAZINE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 126495021 | 12649502 | 12 | C | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 126495021 | 12649502 | 13 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 15 MILLIGRAM/SQ. METER | 0 | UNKNOWN | |||||||||
| 126495021 | 12649502 | 14 | C | IFOSFAMIDE. | IFOSFAMIDE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 126495021 | 12649502 | 15 | C | CISPLATIN. | CISPLATIN | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 126495021 | 12649502 | 16 | C | DECITABINE. | DECITABINE | 1 | Unknown | 0 | 15 | MG/M**2 | UNKNOWN | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126495021 | 12649502 | 1 | Diffuse large B-cell lymphoma |
| 126495021 | 12649502 | 3 | Diffuse large B-cell lymphoma |
| 126495021 | 12649502 | 7 | Product used for unknown indication |
| 126495021 | 12649502 | 8 | Product used for unknown indication |
| 126495021 | 12649502 | 9 | Product used for unknown indication |
| 126495021 | 12649502 | 10 | Product used for unknown indication |
| 126495021 | 12649502 | 11 | Product used for unknown indication |
| 126495021 | 12649502 | 12 | Product used for unknown indication |
| 126495021 | 12649502 | 13 | Product used for unknown indication |
| 126495021 | 12649502 | 14 | Product used for unknown indication |
| 126495021 | 12649502 | 15 | Product used for unknown indication |
| 126495021 | 12649502 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126495021 | 12649502 | OT |
| 126495021 | 12649502 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126495021 | 12649502 | Alanine aminotransferase increased | |
| 126495021 | 12649502 | Anaemia | |
| 126495021 | 12649502 | Aspartate aminotransferase increased | |
| 126495021 | 12649502 | Blood alkaline phosphatase increased | |
| 126495021 | 12649502 | Diarrhoea | |
| 126495021 | 12649502 | Diffuse large B-cell lymphoma | |
| 126495021 | 12649502 | Fatigue | |
| 126495021 | 12649502 | Hyperbilirubinaemia | |
| 126495021 | 12649502 | Hyperglycaemia | |
| 126495021 | 12649502 | Hypoglycaemia | |
| 126495021 | 12649502 | Leukopenia | |
| 126495021 | 12649502 | Nausea | |
| 126495021 | 12649502 | Neutropenia | |
| 126495021 | 12649502 | Pyrexia | |
| 126495021 | 12649502 | Renal impairment | |
| 126495021 | 12649502 | Thrombocytopenia | |
| 126495021 | 12649502 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |