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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125830561 | 12583056 | 1 | I | 20150718 | 20151020 | 20160722 | 20160722 | EXP | IT-CELGENEUS-ITA-2015104938 | CELGENE | 80.00 | YR | F | Y | 0.00000 | 20160722 | PH | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125830561 | 12583056 | 1 | PS | THALIDOMIDE | THALIDOMIDE | 1 | Oral | Y | U | E0009P1 | 20785 | 50 | MG | CAPSULES | QD | ||||
| 125830561 | 12583056 | 2 | SS | THALIDOMIDE | THALIDOMIDE | 1 | Oral | Y | U | E0009P1 | 20785 | 50 | MG | CAPSULES | BID | ||||
| 125830561 | 12583056 | 3 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 25 | MG | TABLETS | QD | |||||||
| 125830561 | 12583056 | 4 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 25 | MG | TABLETS | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125830561 | 12583056 | 1 | Plasma cell myeloma |
| 125830561 | 12583056 | 3 | Plasma cell myeloma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125830561 | 12583056 | OT |
| 125830561 | 12583056 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125830561 | 12583056 | Adverse drug reaction | |
| 125830561 | 12583056 | Apathy | |
| 125830561 | 12583056 | Cardiac failure | |
| 125830561 | 12583056 | Dissociation | |
| 125830561 | 12583056 | Endocarditis | |
| 125830561 | 12583056 | Hyponatraemia | |
| 125830561 | 12583056 | Neuropathy peripheral | |
| 125830561 | 12583056 | Speech disorder |
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 |
|---|---|---|---|---|---|---|
| 125830561 | 12583056 | 1 | 20150323 | 20150607 | 0 | |
| 125830561 | 12583056 | 2 | 20150615 | 20150717 | 0 | |
| 125830561 | 12583056 | 3 | 20150323 | 20150607 | 0 | |
| 125830561 | 12583056 | 4 | 20150615 | 20150717 | 0 |