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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125653383 | 12565338 | 3 | F | 20160708 | 20160909 | 20160718 | 20160913 | EXP | SE-JNJFOC-20160710274 | JANSSEN | 67.00 | YR | E | F | Y | 77.00000 | KG | 20160913 | MD | SE | SE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125653383 | 12565338 | 1 | PS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | Y | N | 4371934 | 761036 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 125653383 | 12565338 | 2 | SS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | Y | N | 4371934 | 100638 | 1232 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||
| 125653383 | 12565338 | 3 | SS | LENALIDOMIDE | LENALIDOMIDE | 1 | Oral | Y | A0480AE | 0 | 15 | MG | UNSPECIFIED | ||||||
| 125653383 | 12565338 | 4 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | Y | 0 | 20 | MG | UNSPECIFIED | /wk | ||||||
| 125653383 | 12565338 | 5 | C | TROMBYL | ASPIRIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125653383 | 12565338 | 2 | Plasma cell myeloma |
| 125653383 | 12565338 | 3 | Plasma cell myeloma |
| 125653383 | 12565338 | 4 | Plasma cell myeloma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125653383 | 12565338 | HO |
| 125653383 | 12565338 | LT |
| 125653383 | 12565338 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125653383 | 12565338 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 125653383 | 12565338 | 2 | 20141125 | 0 | ||
| 125653383 | 12565338 | 3 | 20141125 | 0 | ||
| 125653383 | 12565338 | 4 | 20141125 | 0 |