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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119535659 | 11953565 | 9 | F | 20160121 | 20160926 | 20160126 | 20160929 | EXP | ES-JNJFOC-20160119329 | JANSSEN | 76.79 | YR | E | M | Y | 82.00000 | KG | 20160929 | MD | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119535659 | 11953565 | 1 | PS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | N | 4370774 | 761036 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
| 119535659 | 11953565 | 2 | SS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | 6 TIMES FOR A MONTH, CYCLE 1 DAY 1, 8, 15, 22, 22, 36 | N | 4370774 | 100638 | 1312 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||
| 119535659 | 11953565 | 3 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 8 TIMES FOR A MONTH, CYCLE 1 DAY1, 4, 8, 11, 22, 25, 29, 32 | N | 4371089 | 0 | 2.49 | MG | LYOPHILIZED POWDER | |||||
| 119535659 | 11953565 | 4 | SS | MELPHALAN | MELPHALAN | 1 | Oral | 4 TIMES FOR A MONTH | 4370783 | 0 | 18 | MG | |||||||
| 119535659 | 11953565 | 5 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 0 | 20 | MG | |||||||||
| 119535659 | 11953565 | 6 | C | ACETYLCYSTEINE. | ACETYLCYSTEINE | 1 | Respiratory (inhalation) | D | 0 | 300 | MG | AEROSOLS | TID | ||||||
| 119535659 | 11953565 | 7 | C | ONDANSETRON | ONDANSETRON | 1 | Intravenous (not otherwise specified) | D | 0 | 8 | MG | LIQUID | TID | ||||||
| 119535659 | 11953565 | 8 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | D | 0 | 850 | MG | TABLET | |||||||
| 119535659 | 11953565 | 9 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | D | 0 | 10 | MG | TABLET | |||||||
| 119535659 | 11953565 | 10 | C | ENOXAPARIN | ENOXAPARIN | 1 | Subcutaneous | D | 0 | 40 | MG | INJECTION | |||||||
| 119535659 | 11953565 | 11 | C | CO-RENITEC | ENALAPRILHYDROCHLOROTHIAZIDE | 1 | D | 0 | |||||||||||
| 119535659 | 11953565 | 12 | C | ROSUVASTATIN. | ROSUVASTATIN | 1 | D | 0 | |||||||||||
| 119535659 | 11953565 | 13 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | D | 0 | |||||||||||
| 119535659 | 11953565 | 14 | C | ADIRO | ASPIRIN | 1 | D | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119535659 | 11953565 | 2 | Plasma cell myeloma |
| 119535659 | 11953565 | 3 | Plasma cell myeloma |
| 119535659 | 11953565 | 4 | Plasma cell myeloma |
| 119535659 | 11953565 | 5 | Plasma cell myeloma |
| 119535659 | 11953565 | 6 | Spinal cord compression |
| 119535659 | 11953565 | 7 | Spinal cord compression |
| 119535659 | 11953565 | 8 | Carbohydrate intolerance |
| 119535659 | 11953565 | 9 | Spinal cord compression |
| 119535659 | 11953565 | 10 | Spinal cord compression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119535659 | 11953565 | LT |
| 119535659 | 11953565 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119535659 | 11953565 | Respiratory failure |
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 |
|---|---|---|---|---|---|---|
| 119535659 | 11953565 | 2 | 20151215 | 0 | ||
| 119535659 | 11953565 | 3 | 20151216 | 0 | ||
| 119535659 | 11953565 | 4 | 20151216 | 0 | ||
| 119535659 | 11953565 | 5 | 20151215 | 0 | ||
| 119535659 | 11953565 | 6 | 20151210 | 20160126 | 0 | |
| 119535659 | 11953565 | 7 | 20151206 | 20160126 | 0 | |
| 119535659 | 11953565 | 8 | 20120925 | 20160126 | 0 | |
| 119535659 | 11953565 | 9 | 20151203 | 20160126 | 0 | |
| 119535659 | 11953565 | 10 | 20151129 | 20160126 | 0 |