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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126849102 | 12684910 | 2 | F | 20160227 | 20160826 | 20160825 | 20160909 | EXP | FR-TEVA-686675ROM | TEVA | 21.19 | YR | M | Y | 75.00000 | KG | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126849102 | 12684910 | 1 | PS | ETOPOSIDE TEVA 20 mg/mL | ETOPOSIDE | 1 | Intravenous drip | 390 MILLIGRAM DAILY; | Y | 74284 | 390 | MG | SOLUTION FOR INFUSION | QD | |||||
| 126849102 | 12684910 | 2 | SS | LEVACT 2.5 mg/mL | BENDAMUSTINE HYDROCHLORIDE | 1 | Intravenous drip | 390 MILLIGRAM DAILY; | Y | 0 | 390 | MG | QD | ||||||
| 126849102 | 12684910 | 3 | SS | CYTARABINE SANDOZ 100 mg/mL | CYTARABINE | 1 | Intravenous drip | 780 MILLIGRAM DAILY; | Y | 0 | 390 | MG | SOLUTION FOR INJECTION | BID | |||||
| 126849102 | 12684910 | 4 | SS | ALKERAN | MELPHALAN | 1 | Intravenous (not otherwise specified) | 270 MILLIGRAM DAILY; | Y | 0 | 270 | MG | QD | ||||||
| 126849102 | 12684910 | 5 | C | ONDANSETRON ACCORD 2 mg/mL | ONDANSETRON | 1 | 0 | SOLUTION FOR INJECTION | |||||||||||
| 126849102 | 12684910 | 6 | C | EMEND | APREPITANT | 1 | 0 | ||||||||||||
| 126849102 | 12684910 | 7 | C | METHYLPREDNISOLONE MYLAN | METHYLPREDNISOLONE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126849102 | 12684910 | 3 | Hodgkin's disease |
| 126849102 | 12684910 | 4 | Hodgkin's disease |
| 126849102 | 12684910 | 5 | Prophylaxis of nausea and vomiting |
| 126849102 | 12684910 | 6 | Prophylaxis of nausea and vomiting |
| 126849102 | 12684910 | 7 | Prophylaxis of nausea and vomiting |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126849102 | 12684910 | HO |
| 126849102 | 12684910 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126849102 | 12684910 | Bone marrow failure | |
| 126849102 | 12684910 | Off label use | |
| 126849102 | 12684910 | Pyrexia | |
| 126849102 | 12684910 | Stomatitis |
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 |
|---|---|---|---|---|---|---|
| 126849102 | 12684910 | 1 | 20160218 | 20160221 | 0 | |
| 126849102 | 12684910 | 2 | 20160216 | 20160217 | 0 | |
| 126849102 | 12684910 | 3 | 20160218 | 20160221 | 0 | |
| 126849102 | 12684910 | 4 | 20160222 | 20160222 | 0 |