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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123011283 | 12301128 | 3 | F | 20160308 | 20160629 | 20160425 | 20160708 | EXP | DK-JNJFOC-20160400499 | JANSSEN | 68.65 | YR | E | M | Y | 91.00000 | KG | 20160708 | MD | DK | DK |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123011283 | 12301128 | 1 | PS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | Y | U | 761036 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
| 123011283 | 12301128 | 2 | SS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | FREQUENCY PER PROTOCOL | Y | U | 100638 | 1456 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||
| 123011283 | 12301128 | 3 | SS | LENALIDOMIDE | LENALIDOMIDE | 1 | Oral | Y | 0 | 25 | MG | ||||||||
| 123011283 | 12301128 | 4 | SS | LENALIDOMIDE | LENALIDOMIDE | 1 | Oral | REDUCED | Y | 0 | |||||||||
| 123011283 | 12301128 | 5 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | Y | 0 | 20 | MG | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123011283 | 12301128 | 2 | Plasma cell myeloma |
| 123011283 | 12301128 | 3 | Plasma cell myeloma |
| 123011283 | 12301128 | 4 | Plasma cell myeloma |
| 123011283 | 12301128 | 5 | Plasma cell myeloma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123011283 | 12301128 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123011283 | 12301128 | Cardiac failure | |
| 123011283 | 12301128 | Dyspnoea |
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 |
|---|---|---|---|---|---|---|
| 123011283 | 12301128 | 2 | 20150310 | 20160308 | 0 | |
| 123011283 | 12301128 | 3 | 20160310 | 20160328 | 0 | |
| 123011283 | 12301128 | 5 | 20150310 | 20160406 | 0 |