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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124362262 | 12436226 | 2 | F | 20160410 | 20160726 | 20160605 | 20160729 | EXP | FR-JNJFOC-20160410331 | JANSSEN | 75.60 | YR | E | M | Y | 0.00000 | 20160729 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124362262 | 12436226 | 1 | PS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | N | 4370804 | 761036 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
| 124362262 | 12436226 | 2 | SS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | N | 4370804 | 100638 | 16 | MG/KG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 124362262 | 12436226 | 3 | SS | MELPHALAN | MELPHALAN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124362262 | 12436226 | 4 | SS | DEXAMETHAZONE | DEXAMETHASONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124362262 | 12436226 | 5 | SS | POMALIDOMIDE | POMALIDOMIDE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 124362262 | 12436226 | 6 | C | ORACILLINE | PENICILLIN V | 1 | 1,000,000 UNITS 1-0-1 | 0 | |||||||||||
| 124362262 | 12436226 | 7 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | 0 | 500 | MG | TIW | |||||||||
| 124362262 | 12436226 | 8 | C | LEDERFOLINE | LEUCOVORIN CALCIUM | 1 | 0 | 25 | MG | TIW | |||||||||
| 124362262 | 12436226 | 9 | C | ZELITREX | VALACYCLOVIR HYDROCHLORIDE | 1 | 1-0-1 | 0 | 500 | MG | |||||||||
| 124362262 | 12436226 | 10 | C | KARDEGIC | ASPIRIN LYSINE | 1 | 0-1-0 | 0 | 75 | MG | |||||||||
| 124362262 | 12436226 | 11 | C | INEXIUM | ESOMEPRAZOLE | 1 | 0-0-1 | 0 | 20 | MG | |||||||||
| 124362262 | 12436226 | 12 | C | LYRICA | PREGABALIN | 1 | 1-0-1 | 0 | 75 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124362262 | 12436226 | 2 | Plasma cell myeloma |
| 124362262 | 12436226 | 3 | Plasma cell myeloma |
| 124362262 | 12436226 | 4 | Plasma cell myeloma |
| 124362262 | 12436226 | 5 | Plasma cell myeloma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124362262 | 12436226 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124362262 | 12436226 | Pneumonia | |
| 124362262 | 12436226 | 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 |
|---|---|---|---|---|---|---|
| 124362262 | 12436226 | 2 | 20150917 | 0 |