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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125317741 | 12531774 | 1 | I | 20090626 | 20160629 | 20160706 | 20160706 | EXP | FR-BAXTER-2016BAX034851 | BAXTER | 17.00 | YR | F | Y | 0.00000 | 20160706 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125317741 | 12531774 | 1 | PS | HOLOXAN 2000 MG, POUDRE POUR USAGE PARENT?RAL | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | INFUSION | Y | 0 | POWDER FOR SOLUTION FOR INJECTION | /cycle | |||||||
| 125317741 | 12531774 | 2 | SS | CELLTOP 100 MG/5 ML, SOLUTION INJECTABLE POUR PERFUSION | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | INFUSION (FIRST COURSE) | 0 | SOLUTION FOR INJECTION | /cycle | ||||||||
| 125317741 | 12531774 | 3 | SS | CELLTOP 100 MG/5 ML, SOLUTION INJECTABLE POUR PERFUSION | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | INFUSION (SECOND COURSE) | 0 | SOLUTION FOR INJECTION | /cycle | ||||||||
| 125317741 | 12531774 | 4 | SS | VOGALENE | METOPIMAZINE | 1 | Intravenous (not otherwise specified) | AMPOULE | U | 0 | SOLUTION FOR INJECTION | ||||||||
| 125317741 | 12531774 | 5 | SS | EMEND | APREPITANT | 1 | Oral | U | 0 | ||||||||||
| 125317741 | 12531774 | 6 | SS | ZOPHREN | ONDANSETRON | 1 | Unknown | U | 0 | ||||||||||
| 125317741 | 12531774 | 7 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | FIRST COURSE; HIGH DOSE | U | 0 | /cycle |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125317741 | 12531774 | 1 | Osteosarcoma |
| 125317741 | 12531774 | 2 | Osteosarcoma |
| 125317741 | 12531774 | 3 | Off label use |
| 125317741 | 12531774 | 4 | Prophylaxis of nausea and vomiting |
| 125317741 | 12531774 | 5 | Product used for unknown indication |
| 125317741 | 12531774 | 6 | Product used for unknown indication |
| 125317741 | 12531774 | 7 | Chemotherapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125317741 | 12531774 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125317741 | 12531774 | Asthenopia | |
| 125317741 | 12531774 | Condition aggravated | |
| 125317741 | 12531774 | Feeling abnormal | |
| 125317741 | 12531774 | Myoclonus | |
| 125317741 | 12531774 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 125317741 | 12531774 | 1 | 20090626 | 20090629 | 0 | |
| 125317741 | 12531774 | 2 | 20090626 | 20090629 | 0 | |
| 125317741 | 12531774 | 3 | 20090729 | 0 | ||
| 125317741 | 12531774 | 4 | 20090626 | 20090628 | 0 | |
| 125317741 | 12531774 | 5 | 20090801 | 20090801 | 0 |