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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121881642 | 12188164 | 2 | F | 201012 | 20160809 | 20160317 | 20160818 | EXP | JP-TAKEDA-2016MPI001828 | TAKEDA | SHIMURA K.. BORTEZOMIB AND HIGH-DOSE MELPHALAN AS CONDITIONING REGIMEN BEFORE AUTOLOGOUSSTEM CELL TRANSPLANTATION IN 10 PATIENTS WITH DE NOVO MULTIPLE MYELOMA.. 38TH ANNUAL MEETING OF THE JAPAN SOCIETY FOR HEMATOPOIETIC CELL TRANSPLANTATION. 2016;248 | 7.00 | DEC | M | Y | 0.00000 | 20160818 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121881642 | 12188164 | 1 | PS | VELCADE | BORTEZOMIB | 1 | Unknown | 1 MG/M2, Q3WEEKS | Y | 21602 | 1 | MG/M**2 | INJECTION | Q3W | |||||
| 121881642 | 12188164 | 2 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 20 MG, QD | 1220 | MG | 0 | 20 | MG | QD | |||||
| 121881642 | 12188164 | 3 | C | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 121881642 | 12188164 | 4 | C | MELPHALAN | MELPHALAN | 1 | Unknown | 200 MG/M2, QD | 200 | MG/M2 | 0 | 200 | MG/M**2 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121881642 | 12188164 | 1 | Plasma cell myeloma |
| 121881642 | 12188164 | 2 | Plasma cell myeloma |
| 121881642 | 12188164 | 3 | Plasma cell myeloma |
| 121881642 | 12188164 | 4 | Stem cell transplant |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121881642 | 12188164 | OT |
| 121881642 | 12188164 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121881642 | 12188164 | Diarrhoea | |
| 121881642 | 12188164 | Enterocolitis haemorrhagic | |
| 121881642 | 12188164 | Ileus paralytic | |
| 121881642 | 12188164 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 121881642 | 12188164 | 1 | 20101104 | 20110426 | 0 | |
| 121881642 | 12188164 | 2 | 20101104 | 20110103 | 0 | |
| 121881642 | 12188164 | 4 | 20110420 | 20110420 | 0 |