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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125973052 | 12597305 | 2 | F | 201401 | 20160712 | 20160726 | 20160802 | EXP | DK-JNJFOC-20160716077 | JANSSEN | ANDERSEN NB, BOYSEN AK, ROSSEN PB, LUCKE AO, SAFWAT AA. BILATERAL AVASCULAR NECROSIS OF THE FEMORAL HEAD FOLLOWING TREATMENT OF EWINGS SARCOMA. ACTA ONCOLOGICA. 2016;55(6):792-795. | 28.00 | YR | A | M | Y | 0.00000 | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125973052 | 12597305 | 1 | PS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | DAY 1 TO 3 | N | 50718 | 20 | MG/M**2 | LIPOSOME INJECTION | ||||||
| 125973052 | 12597305 | 2 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | DAY 1 TO 3 | 0 | 150 | MG/M**2 | UNSPECIFIED | |||||||
| 125973052 | 12597305 | 3 | SS | ACTINOMYCIN D | DACTINOMYCIN | 1 | Unknown | 6 CYCLES D1 TO2 | 0 | .75 | MG/M**2 | UNSPECIFIED | |||||||
| 125973052 | 12597305 | 4 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | 0 | INTRAVENOUS INFUSION | ||||||||||
| 125973052 | 12597305 | 5 | SS | VINCRISTINE | VINCRISTINE | 1 | Unknown | 6 CYCLES DAY 1 | 0 | 1.5 | MG/M**2 | UNSPECIFIED | |||||||
| 125973052 | 12597305 | 6 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Unknown | DAY 1 TO 2 | 0 | 3 | MG/M**2 | UNSPECIFIED | |||||||
| 125973052 | 12597305 | 7 | SS | IRINOTECAN | IRINOTECAN | 1 | Unknown | D 1 TO 5 | U | 0 | 10 | MG/M**2 | UNSPECIFIED | ||||||
| 125973052 | 12597305 | 8 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Unknown | D 1 TO 5 | U | 0 | 100 | MG/M**2 | UNSPECIFIED | ||||||
| 125973052 | 12597305 | 9 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125973052 | 12597305 | 1 | Ewing's sarcoma |
| 125973052 | 12597305 | 2 | Ewing's sarcoma |
| 125973052 | 12597305 | 3 | Ewing's sarcoma |
| 125973052 | 12597305 | 4 | Ewing's sarcoma |
| 125973052 | 12597305 | 5 | Ewing's sarcoma |
| 125973052 | 12597305 | 6 | Ewing's sarcoma |
| 125973052 | 12597305 | 7 | Ewing's sarcoma |
| 125973052 | 12597305 | 8 | Ewing's sarcoma |
| 125973052 | 12597305 | 9 | Antiemetic supportive care |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125973052 | 12597305 | OT |
| 125973052 | 12597305 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125973052 | 12597305 | Off label use | |
| 125973052 | 12597305 | Osteonecrosis | |
| 125973052 | 12597305 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 125973052 | 12597305 | 1 | 201309 | 0 | ||
| 125973052 | 12597305 | 2 | 201309 | 0 | ||
| 125973052 | 12597305 | 3 | 201309 | 0 | ||
| 125973052 | 12597305 | 4 | 201309 | 0 | ||
| 125973052 | 12597305 | 5 | 201309 | 0 | ||
| 125973052 | 12597305 | 6 | 201309 | 0 |