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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120909044 | 12090904 | 4 | F | 20150712 | 20160802 | 20160218 | 20160804 | EXP | NL-JNJFOC-20150709904 | JANSSEN | 62.80 | YR | A | M | Y | 67.00000 | KG | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120909044 | 12090904 | 1 | PS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | N | N | 761036 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
| 120909044 | 12090904 | 2 | SS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | FREQUENCY: 10 TIMES TOTAL (4 CYCLES) | N | N | 100638 | 1070 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||
| 120909044 | 12090904 | 3 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | FREQUENCY: 4 TIMES PER CYCLE | N | N | 0 | 2.375 | MG | LYOPHILIZED POWDER | |||||
| 120909044 | 12090904 | 4 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | FREQUENCY: 9 TIMES | N | N | 0 | 20 | MG | TABLET | |||||
| 120909044 | 12090904 | 5 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | FREQUENCY: 9 TIMES | N | N | 0 | 20 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||
| 120909044 | 12090904 | 6 | C | METOPROLOL. | METOPROLOL | 1 | 0 | 50 | MG | ||||||||||
| 120909044 | 12090904 | 7 | C | PANTOPRAZOLE SODIUM. | PANTOPRAZOLE SODIUM | 1 | 0 | 40 | MG | ||||||||||
| 120909044 | 12090904 | 8 | C | OXYCODON | OXYCODONE | 1 | 0 | 80 | MG | ||||||||||
| 120909044 | 12090904 | 9 | C | OXYNORM | OXYCODONE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 120909044 | 12090904 | 10 | C | ACENOCOUMAROL | ACENOCOUMAROL | 1 | 0 | ||||||||||||
| 120909044 | 12090904 | 11 | C | ZELITREX | VALACYCLOVIR HYDROCHLORIDE | 1 | 0 | 1000 | MG | ||||||||||
| 120909044 | 12090904 | 12 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 0 | 20 | MG | ||||||||||
| 120909044 | 12090904 | 13 | C | ZOPICLON | ZOPICLONE | 1 | 0 | 7.5 | MG | ||||||||||
| 120909044 | 12090904 | 14 | C | MOVICOLON | POLYETHYLENE GLYCOL 3350POTASSIUM CHLORIDESODIUM BICARBONATESODIUM CHLORIDE | 1 | 0 | ||||||||||||
| 120909044 | 12090904 | 15 | C | LACTULOSE. | LACTULOSE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120909044 | 12090904 | 2 | Plasma cell myeloma |
| 120909044 | 12090904 | 3 | Plasma cell myeloma |
| 120909044 | 12090904 | 4 | Plasma cell myeloma |
| 120909044 | 12090904 | 5 | Plasma cell myeloma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120909044 | 12090904 | DS |
| 120909044 | 12090904 | HO |
| 120909044 | 12090904 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120909044 | 12090904 | Pneumonia | |
| 120909044 | 12090904 | Pulmonary 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 |
|---|---|---|---|---|---|---|
| 120909044 | 12090904 | 2 | 20141216 | 20150707 | 0 | |
| 120909044 | 12090904 | 3 | 20141216 | 20150707 | 0 | |
| 120909044 | 12090904 | 4 | 20141216 | 20150707 | 0 | |
| 120909044 | 12090904 | 5 | 20141216 | 20150707 | 0 |