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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122493462 | 12249346 | 2 | F | 20151020 | 20160721 | 20160408 | 20160728 | EXP | KR-TAKEDA-2016MPI002546 | TAKEDA | 67.15 | YR | F | Y | 54.00000 | KG | 20160728 | MD | KR | KR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122493462 | 12249346 | 1 | PS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 2 MG, UNK | Y | 4370903 | 21602 | 2 | MG | INJECTION | |||||
| 122493462 | 12249346 | 2 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 1.5 MG, UNK | Y | 4370903 | 21602 | 1.5 | MG | INJECTION | |||||
| 122493462 | 12249346 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 90 MG, UNK | 4371050 | 0 | 90 | MG | |||||||
| 122493462 | 12249346 | 4 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 20 MG, 1/WEEK | Y | 0 | 20 | MG | /wk | ||||||
| 122493462 | 12249346 | 5 | SS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | 896 MG, 1/WEEK | Y | 4370491 | 0 | 896 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||
| 122493462 | 12249346 | 6 | SS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | 896 MG, 1/WEEK | Y | 4370491 | 0 | 896 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||
| 122493462 | 12249346 | 7 | SS | MELPHALAN | MELPHALAN | 1 | Oral | 14 MG, UNK | 4371043 | 0 | 14 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122493462 | 12249346 | 1 | Plasma cell myeloma |
| 122493462 | 12249346 | 3 | Plasma cell myeloma |
| 122493462 | 12249346 | 4 | Plasma cell myeloma |
| 122493462 | 12249346 | 5 | Plasma cell myeloma |
| 122493462 | 12249346 | 7 | Plasma cell myeloma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122493462 | 12249346 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122493462 | 12249346 | Chills | |
| 122493462 | 12249346 | Cough | |
| 122493462 | 12249346 | Eye movement disorder | |
| 122493462 | 12249346 | Respiratory arrest | |
| 122493462 | 12249346 | Syncope | |
| 122493462 | 12249346 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 122493462 | 12249346 | 1 | 20151020 | 20151030 | 0 | |
| 122493462 | 12249346 | 2 | 20151113 | 0 | ||
| 122493462 | 12249346 | 3 | 20151021 | 0 | ||
| 122493462 | 12249346 | 4 | 20151020 | 0 | ||
| 122493462 | 12249346 | 5 | 20151020 | 20151027 | 0 | |
| 122493462 | 12249346 | 6 | 20151113 | 0 | ||
| 122493462 | 12249346 | 7 | 20151020 | 0 |