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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125283371 | 12528337 | 1 | I | 20160503 | 20160705 | 20160705 | EXP | IT-TAKEDA-2016MPI006083 | TAKEDA | 0.00 | Y | 0.00000 | 20160705 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125283371 | 12528337 | 1 | PS | VELCADE | BORTEZOMIB | 1 | Intravenous (not otherwise specified) | 1.3 MG/M2, Q2WEEKS | U | 21602 | 1.3 | MG/M**2 | INJECTION | QOW | |||||
| 125283371 | 12528337 | 2 | SS | VELCADE | BORTEZOMIB | 1 | Intravenous (not otherwise specified) | 1.3 MG/M2, UNK | U | 21602 | 1.3 | MG/M**2 | INJECTION | QOW | |||||
| 125283371 | 12528337 | 3 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125283371 | 12528337 | 4 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125283371 | 12528337 | 1 | Plasma cell myeloma |
| 125283371 | 12528337 | 3 | Plasma cell myeloma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125283371 | 12528337 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125283371 | 12528337 | Haemoglobinaemia | |
| 125283371 | 12528337 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 125283371 | 12528337 | 1 | 20130628 | 0 |