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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122106853 | 12210685 | 3 | F | 20160229 | 20160701 | 20160325 | 20160708 | EXP | GB-JNJFOC-20160304330 | JANSSEN | 72.00 | YR | E | F | Y | 81.80000 | KG | 20160708 | MD | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122106853 | 12210685 | 1 | PS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | Y | N | 4371371 | 761036 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 122106853 | 12210685 | 2 | SS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | CYCLE 1 DAY 8 ON 04-MAR-2016 AND CYCLE 1 DAY 15 ON 10-MAR-2016 | Y | N | 4371371 | 100638 | 1312 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||
| 122106853 | 12210685 | 3 | SS | LENALIDOMIDE | LENALIDOMIDE | 1 | Oral | A0494AA | 0 | 10 | MG | UNSPECIFIED | QD | ||||||
| 122106853 | 12210685 | 4 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | CYCLE 1 DAY 8 ON 04-MAR-2016 AND CYCLE 1 DAY 15 ON 10-MAR-2016 | 546061 | 0 | 40 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122106853 | 12210685 | 2 | Plasma cell myeloma |
| 122106853 | 12210685 | 3 | Plasma cell myeloma |
| 122106853 | 12210685 | 4 | Plasma cell myeloma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122106853 | 12210685 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122106853 | 12210685 | Pyrexia | |
| 122106853 | 12210685 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 122106853 | 12210685 | 2 | 20160226 | 20160310 | 0 | |
| 122106853 | 12210685 | 3 | 20160226 | 0 | ||
| 122106853 | 12210685 | 4 | 20160226 | 0 |