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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124618444 | 12461844 | 4 | F | 20160517 | 20160915 | 20160613 | 20160929 | EXP | NL-CELGENEUS-NLD-2016060040 | CELGENE | 37.00 | YR | F | Y | 0.00000 | 20160929 | MD | NL | NL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124618444 | 12461844 | 1 | PS | REVLIMID | LENALIDOMIDE | 1 | Oral | 15 MILLIGRAM | U | 21880 | 15 | MG | CAPSULES | QD | |||||
| 124618444 | 12461844 | 2 | SS | REVLIMID | LENALIDOMIDE | 1 | U | 21880 | |||||||||||
| 124618444 | 12461844 | 3 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | U | 0 | 14.5 | MG/KG | UNKNOWN | |||||||
| 124618444 | 12461844 | 4 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | U | 0 | |||||||||||
| 124618444 | 12461844 | 5 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124618444 | 12461844 | 1 | Acute myeloid leukaemia |
| 124618444 | 12461844 | 2 | Myelodysplastic syndrome |
| 124618444 | 12461844 | 3 | Acute myeloid leukaemia |
| 124618444 | 12461844 | 4 | Myelodysplastic syndrome |
| 124618444 | 12461844 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124618444 | 12461844 | LT |
| 124618444 | 12461844 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124618444 | 12461844 | Pneumonia | |
| 124618444 | 12461844 | Respiratory failure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 124618444 | 12461844 | 1 | 20160325 | 20160414 | 0 | |
| 124618444 | 12461844 | 3 | 20160427 | 0 |