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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127380013 | 12738001 | 3 | F | 20150724 | 20160915 | 20160913 | 20160928 | EXP | CA-TAKEDA-2016MPI007791 | TAKEDA | 50.00 | YR | F | Y | 0.00000 | 20160928 | MD | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127380013 | 12738001 | 1 | PS | VELCADE | BORTEZOMIB | 1 | Unknown | 1.3 MG/M2, Q2WEEKS | 21602 | 1.3 | MG/M**2 | INJECTION | QOW | ||||||
| 127380013 | 12738001 | 2 | SS | VELCADE | BORTEZOMIB | 1 | Unknown | 1.3 MG/M2, 1/WEEK | 21602 | 1.3 | MG/M**2 | INJECTION | /wk | ||||||
| 127380013 | 12738001 | 3 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | UNK | U | 0 | |||||||||
| 127380013 | 12738001 | 4 | SS | CARVEDILOL. | CARVEDILOL | 1 | Unknown | UNK | Y | 0 | TABLET | ||||||||
| 127380013 | 12738001 | 5 | SS | CARVEDILOL. | CARVEDILOL | 1 | Unknown | 3.25 MG, UNK | Y | 0 | 3.25 | MG | TABLET | ||||||
| 127380013 | 12738001 | 6 | SS | ATACAND | CANDESARTAN CILEXETIL | 1 | Oral | UNK | Y | 0 | |||||||||
| 127380013 | 12738001 | 7 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127380013 | 12738001 | 1 | Amyloidosis |
| 127380013 | 12738001 | 3 | Amyloidosis |
| 127380013 | 12738001 | 4 | Product used for unknown indication |
| 127380013 | 12738001 | 6 | Product used for unknown indication |
| 127380013 | 12738001 | 7 | Amyloidosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127380013 | 12738001 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127380013 | 12738001 | Blood creatinine increased | |
| 127380013 | 12738001 | Decreased appetite | |
| 127380013 | 12738001 | Diarrhoea | |
| 127380013 | 12738001 | Dizziness | |
| 127380013 | 12738001 | Fall | |
| 127380013 | 12738001 | Fatigue | |
| 127380013 | 12738001 | Hypotension | |
| 127380013 | 12738001 | Light chain analysis increased | |
| 127380013 | 12738001 | Nausea | |
| 127380013 | 12738001 | Off label use | |
| 127380013 | 12738001 | Paraesthesia | |
| 127380013 | 12738001 | Product use issue | |
| 127380013 | 12738001 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 127380013 | 12738001 | 1 | 201109 | 0 | ||
| 127380013 | 12738001 | 2 | 201207 | 0 |