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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125807012 | 12580701 | 2 | F | 201401 | 20160720 | 20160721 | 20160801 | EXP | DK-ACTAVIS-2016-15969 | ACTAVIS | ANDERSEN NB, BOYSEN AK, ROSSEN PB, L?CKE AO, SAFWAT AA. BILATERAL AVASCULAR NECROSIS OF THE FEMORAL HEAD FOLLOWING TREATMENT OF EWING?S SARCOMA. ACTA ONCOL. 2016;55(6):792-5. | 28.00 | YR | M | Y | 0.00000 | 20160801 | MD | DK | DK |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125807012 | 12580701 | 1 | PS | Doxorubicin (Unknown) | DOXORUBICIN | 1 | Unknown | SIX CYCLES;D 1-3 | UNCONFIRMED | 203622 | 20 | MG/M**2 | UNK | ||||||
| 125807012 | 12580701 | 2 | SS | Vincristine (Unknown) | VINCRISTINE | 1 | Unknown | 1.5 MG/M2, CYCLICAL; SIX CYCLES D1 | UNCONFIRMED | 0 | 1.5 | MG/M**2 | UNK | ||||||
| 125807012 | 12580701 | 3 | SS | Vincristine (Unknown) | VINCRISTINE | 1 | Unknown | 1.5 MG/M2, CYCLICAL; SIX CYCLES D1 | UNCONFIRMED | 0 | 1.5 | MG/M**2 | UNK | ||||||
| 125807012 | 12580701 | 4 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Unknown | 3 MG/M2, CYCLICAL; , 6 CYCLES3 D1-3 | 0 | 3 | MG/M**2 | ||||||||
| 125807012 | 12580701 | 5 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Parenteral | TWO CYCLES; SINGLE AGENT | 0 | ||||||||||
| 125807012 | 12580701 | 6 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Unknown | 3 MG/M2, CYCLICAL; , 6 CYCLES3 D1-2 | 0 | 3 | MG/M**2 | ||||||||
| 125807012 | 12580701 | 7 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | 150 MG/M2, CYCLICAL;SIX CYCLES; D 1-3 | UNCONFIRMED | 0 | 150 | MG/M**2 | |||||||
| 125807012 | 12580701 | 8 | SS | ACTINOMYCIN D | DACTINOMYCIN | 1 | Unknown | 0.75 MG/M2, CYCLICAL; SIX CYCLES; D 1?2 | 0 | .75 | MG/M**2 | ||||||||
| 125807012 | 12580701 | 9 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125807012 | 12580701 | 1 | Ewing's sarcoma |
| 125807012 | 12580701 | 2 | Ewing's sarcoma |
| 125807012 | 12580701 | 4 | Ewing's sarcoma |
| 125807012 | 12580701 | 7 | Ewing's sarcoma |
| 125807012 | 12580701 | 8 | Ewing's sarcoma |
| 125807012 | 12580701 | 9 | Antiemetic supportive care |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125807012 | 12580701 | DS |
| 125807012 | 12580701 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125807012 | 12580701 | Osteonecrosis |
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 |
|---|---|---|---|---|---|---|
| 125807012 | 12580701 | 1 | 201309 | 0 | ||
| 125807012 | 12580701 | 2 | 201309 | 0 | ||
| 125807012 | 12580701 | 4 | 201309 | 0 | ||
| 125807012 | 12580701 | 7 | 201309 | 0 | ||
| 125807012 | 12580701 | 8 | 201309 | 0 | ||
| 125807012 | 12580701 | 9 | 201309 | 0 |