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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124327945 | 12432794 | 5 | F | 20160405 | 20160727 | 20160603 | 20160804 | EXP | DE-TAKEDA-2016MPI002880 | TAKEDA | 83.00 | YR | M | Y | 75.00000 | KG | 20160804 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124327945 | 12432794 | 1 | PS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 2 MG, UNK | Y | 21602 | 2 | MG | INJECTION | ||||||
| 124327945 | 12432794 | 2 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 2 MG, UNK | Y | 21602 | 2 | MG | INJECTION | ||||||
| 124327945 | 12432794 | 3 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 100 MG, UNK | 0 | 100 | MG | ||||||||
| 124327945 | 12432794 | 4 | SS | Levact | BENDAMUSTINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 170 MG, UNK | 0 | 170 | MG | INJECTION | |||||||
| 124327945 | 12432794 | 5 | C | VALSARTAN. | VALSARTAN | 1 | Oral | 120 MG, UNK | 0 | 120 | MG | ||||||||
| 124327945 | 12432794 | 6 | C | ISOSORBID MONONITRATE | ISOSORBIDE MONONITRATE | 1 | Oral | 40 MG, UNK | 0 | 40 | MG | ||||||||
| 124327945 | 12432794 | 7 | C | CLEXANE | ENOXAPARIN SODIUM | 1 | Subcutaneous | 0.7 ML, UNK | 0 | .7 | ML | ||||||||
| 124327945 | 12432794 | 8 | C | BICANORM | SODIUM BICARBONATE | 1 | Oral | 8000 MG, UNK | 0 | 8000 | MG | ||||||||
| 124327945 | 12432794 | 9 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 100 MG, UNK | 0 | 100 | MG | ||||||||
| 124327945 | 12432794 | 10 | C | DIGITOXIN | DIGITOXIN | 1 | Oral | 0.05 MG, UNK | 0 | .05 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124327945 | 12432794 | 1 | Plasma cell myeloma |
| 124327945 | 12432794 | 3 | Plasma cell myeloma |
| 124327945 | 12432794 | 4 | Plasma cell myeloma |
| 124327945 | 12432794 | 5 | Hypertension |
| 124327945 | 12432794 | 6 | Arrhythmia |
| 124327945 | 12432794 | 7 | Venous thrombosis |
| 124327945 | 12432794 | 8 | Renal failure |
| 124327945 | 12432794 | 9 | Cerebral infarction |
| 124327945 | 12432794 | 10 | Arrhythmia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124327945 | 12432794 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124327945 | 12432794 | Atrial fibrillation | |
| 124327945 | 12432794 | Dizziness | |
| 124327945 | 12432794 | Hypotension | |
| 124327945 | 12432794 | Tachyarrhythmia |
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 |
|---|---|---|---|---|---|---|
| 124327945 | 12432794 | 1 | 20160321 | 20160331 | 0 | |
| 124327945 | 12432794 | 2 | 20160411 | 20160511 | 0 | |
| 124327945 | 12432794 | 3 | 20160321 | 0 | ||
| 124327945 | 12432794 | 4 | 20160321 | 0 | ||
| 124327945 | 12432794 | 5 | 20160518 | 0 | ||
| 124327945 | 12432794 | 6 | 20160423 | 20160518 | 0 | |
| 124327945 | 12432794 | 7 | 1991 | 0 | ||
| 124327945 | 12432794 | 8 | 20160321 | 0 | ||
| 124327945 | 12432794 | 9 | 1991 | 20160518 | 0 | |
| 124327945 | 12432794 | 10 | 20160415 | 20160518 | 0 |