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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124330413 | 12433041 | 3 | F | 20160119 | 20160824 | 20160603 | 20160906 | PER | US-TAKEDA-2016MPI004658 | TAKEDA | 75.21 | YR | M | Y | 78.91000 | KG | 20160906 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124330413 | 12433041 | 1 | PS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 1.5 MG/M2, 1/WEEK | U | 21602 | 1.5 | MG/M**2 | INJECTION | /wk | |||||
| 124330413 | 12433041 | 2 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 40 MG, 1/WEEK | U | 0 | 40 | MG | /wk | ||||||
| 124330413 | 12433041 | 3 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Oral | 500 MG, 1/WEEK | U | 0 | 500 | MG | /wk | ||||||
| 124330413 | 12433041 | 4 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | 5 MG, UNK | U | 0 | 5 | MG | |||||||
| 124330413 | 12433041 | 5 | C | CARDURA | DOXAZOSIN MESYLATE | 1 | Unknown | 4 MG, UNK | U | 0 | 4 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124330413 | 12433041 | 1 | Plasma cell myeloma |
| 124330413 | 12433041 | 2 | Plasma cell myeloma |
| 124330413 | 12433041 | 3 | Plasma cell myeloma |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124330413 | 12433041 | Abdominal discomfort | |
| 124330413 | 12433041 | Decreased appetite | |
| 124330413 | 12433041 | Drug ineffective | |
| 124330413 | 12433041 | Dry mouth | |
| 124330413 | 12433041 | Flatulence | |
| 124330413 | 12433041 | Injection site erythema | |
| 124330413 | 12433041 | Injection site exfoliation | |
| 124330413 | 12433041 | Injection site pain | |
| 124330413 | 12433041 | Injection site rash | |
| 124330413 | 12433041 | Injection site reaction | |
| 124330413 | 12433041 | Thirst |
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 |
|---|---|---|---|---|---|---|
| 124330413 | 12433041 | 1 | 20160119 | 0 | ||
| 124330413 | 12433041 | 2 | 201601 | 0 | ||
| 124330413 | 12433041 | 3 | 201601 | 201606 | 0 |