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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119246782 | 11924678 | 2 | F | 20151208 | 20160811 | 20160118 | 20160818 | EXP | NL-TAKEDA-2016MPI000147 | TAKEDA | 67.00 | YR | F | Y | 104.00000 | KG | 20160818 | MD | NL | NL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119246782 | 11924678 | 1 | PS | BLINDED Ixazomib | IXAZOMIB | 1 | Unknown | UNK | 208462 | CAPSULE | |||||||||
| 119246782 | 11924678 | 2 | SS | BLINDED Placebo | INVESTIGATIONAL PRODUCT | 1 | Unknown | UNK | 208462 | CAPSULE | |||||||||
| 119246782 | 11924678 | 3 | SS | MLN9708 | IXAZOMIB | 1 | Oral | 4 MG, UNK | 208462 | 4 | MG | CAPSULE | |||||||
| 119246782 | 11924678 | 4 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 40 MG, UNK | 0 | 40 | MG | ||||||||
| 119246782 | 11924678 | 5 | C | THALIDOMIDE | THALIDOMIDE | 1 | Oral | 100 MG, UNK | U | 0 | 100 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119246782 | 11924678 | 1 | Plasma cell myeloma |
| 119246782 | 11924678 | 2 | Plasma cell myeloma |
| 119246782 | 11924678 | 3 | Plasma cell myeloma |
| 119246782 | 11924678 | 4 | Plasma cell myeloma |
| 119246782 | 11924678 | 5 | Plasma cell myeloma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119246782 | 11924678 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119246782 | 11924678 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 119246782 | 11924678 | 3 | 20151125 | 20151202 | 0 | |
| 119246782 | 11924678 | 4 | 20151125 | 20151202 | 0 | |
| 119246782 | 11924678 | 5 | 20151125 | 0 |