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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125455221 | 12545522 | 1 | I | 20160615 | 20160625 | 20160711 | 20160711 | EXP | US-OTSUKA-2016_016695 | OTSUKA | 52.45 | YR | M | Y | 82.90000 | KG | 20160711 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125455221 | 12545522 | 1 | PS | DECITABINE. | DECITABINE | 1 | Intravenous (not otherwise specified) | 40.1 MG, UNK | 21790 | 40.1 | MG | INJECTION | |||||||
| 125455221 | 12545522 | 2 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 6 MG, ON DAYS 1, 4, 8 AND 11 OF A 28 DAY CYCLE | 0 | 6 | MG | ||||||||
| 125455221 | 12545522 | 3 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | 80 MG, UNK | U | 0 | 80 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125455221 | 12545522 | 1 | Acute myeloid leukaemia |
| 125455221 | 12545522 | 2 | Acute myeloid leukaemia |
| 125455221 | 12545522 | 3 | Acute myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125455221 | 12545522 | HO |
| 125455221 | 12545522 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125455221 | 12545522 | Abdominal pain | |
| 125455221 | 12545522 | Diarrhoea | |
| 125455221 | 12545522 | Neutropenic colitis |
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 |
|---|---|---|---|---|---|---|
| 125455221 | 12545522 | 1 | 20160603 | 20160612 | 0 | |
| 125455221 | 12545522 | 2 | 20160603 | 20160613 | 0 | |
| 125455221 | 12545522 | 3 | 20160606 | 0 |