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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126657491 | 12665749 | 1 | I | 20160623 | 20160810 | 20160818 | 20160818 | EXP | FR-JNJFOC-20160807931 | JANSSEN | 78.34 | YR | E | M | Y | 0.00000 | 20160818 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126657491 | 12665749 | 1 | PS | DARZALEX | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | Y | N | 761036 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
| 126657491 | 12665749 | 2 | SS | REVLIMID | LENALIDOMIDE | 1 | Oral | Y | 0 | 25 | MG | CAPSULE | |||||||
| 126657491 | 12665749 | 3 | SS | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Oral | Y | 0 | UNSPECIFIED | |||||||||
| 126657491 | 12665749 | 4 | C | PERINDOPRIL | PERINDOPRIL | 1 | 0 | 10 | MG | ||||||||||
| 126657491 | 12665749 | 5 | C | METFORMINE | METFORMIN HYDROCHLORIDE | 1 | 0 | 700 | MG | BID | |||||||||
| 126657491 | 12665749 | 6 | C | KARDEGIC | ASPIRIN LYSINE | 1 | 0 | 75 | MG | ||||||||||
| 126657491 | 12665749 | 7 | C | SIMVASTATINE | SIMVASTATIN | 1 | 0 | 10 | MG | ||||||||||
| 126657491 | 12665749 | 8 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | 0 | .25 | MG | ||||||||||
| 126657491 | 12665749 | 9 | C | SKENAN | MORPHINE SULFATE | 1 | 0 | 40 | MG | BID | |||||||||
| 126657491 | 12665749 | 10 | C | AMOXICILLIN. | AMOXICILLIN | 1 | 0 | 1 | G | TID | |||||||||
| 126657491 | 12665749 | 11 | C | EFFERALGAN | ACETAMINOPHEN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126657491 | 12665749 | 1 | Plasma cell myeloma |
| 126657491 | 12665749 | 2 | Plasma cell myeloma |
| 126657491 | 12665749 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126657491 | 12665749 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126657491 | 12665749 | Hyponatraemia | |
| 126657491 | 12665749 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 126657491 | 12665749 | 1 | 20160623 | 20160707 | 0 | |
| 126657491 | 12665749 | 2 | 20160623 | 20160713 | 0 | |
| 126657491 | 12665749 | 3 | 20160627 | 20160715 | 0 | |
| 126657491 | 12665749 | 10 | 20160615 | 0 |