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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127816661 | 12781666 | 1 | I | 20150402 | 20150415 | 20160926 | 20160926 | EXP | FR-TAKEDA-2015MPI002413 | TAKEDA | 78.00 | YR | M | Y | 71.00000 | KG | 20160926 | MD | FR | FR |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127816661 | 12781666 | 1 | PS | BLINDED Ixazomib | IXAZOMIB | 1 | Oral | 4 MG, UNK | U | 208462 | 4 | MG | CAPSULE | ||||||
127816661 | 12781666 | 2 | SS | BLINDED Placebo | INVESTIGATIONAL PRODUCT | 1 | Oral | 4 MG, UNK | U | 208462 | 4 | MG | CAPSULE | ||||||
127816661 | 12781666 | 3 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 40 MG, UNK | U | 0 | 40 | MG | TABLET | ||||||
127816661 | 12781666 | 4 | SS | Lenalidomide | LENALIDOMIDE | 1 | Oral | 25 MG, UNK | U | 0 | 25 | MG | CAPSULE |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
127816661 | 12781666 | 1 | Plasma cell myeloma |
127816661 | 12781666 | 2 | Plasma cell myeloma |
127816661 | 12781666 | 3 | Plasma cell myeloma |
127816661 | 12781666 | 4 | Plasma cell myeloma |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
127816661 | 12781666 | HO |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
127816661 | 12781666 | Anaemia | |
127816661 | 12781666 | Platelet count 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 |
---|---|---|---|---|---|---|
127816661 | 12781666 | 1 | 20150121 | 20150403 | 0 | |
127816661 | 12781666 | 2 | 20150121 | 20150403 | 0 | |
127816661 | 12781666 | 3 | 20150121 | 20150410 | 0 | |
127816661 | 12781666 | 4 | 20150121 | 20150409 | 0 |