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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127800241 | 12780024 | 1 | I | 20160914 | 20160926 | 20160926 | EXP | DK-CORDEN PHARMA LATINA S.P.A.-DK-2016COR000218 | CORDEN | ANDERSEN NB, BOYSEN AK, ROSSEN PB, LUCKE AO, SAFWAT AA. BILATERAL AVASCULAR NECROSIS OF THE FEMORAL HEAD FOLLOWING TREATMENT OF EWING^S SARCOMA. ACTA ONCOL. 2016;55 (6):792-795 | 28.00 | YR | M | Y | 0.00000 | 20160926 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127800241 | 12780024 | 1 | PS | ETOPOSIDE. | ETOPOSIDE | 1 | 150 MG/M2, DAYS 1-3 [6 CYCLES] | Y | 18768 | 150 | MG/M**2 | ||||||||
| 127800241 | 12780024 | 2 | SS | VINCRISTINE | VINCRISTINE | 1 | 1.5 MG/M2, DAY 1 [6 CYCLES] | Y | 0 | 1.5 | MG/M**2 | ||||||||
| 127800241 | 12780024 | 3 | SS | VINCRISTINE | VINCRISTINE | 1 | 1.5 MG/M2, DAY 1 [6 CYCLES] | Y | 0 | 1.5 | MG/M**2 | ||||||||
| 127800241 | 12780024 | 4 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | 3 MG/M2, DAYS 1-3 [6 CYCLES] | Y | 0 | 3 | MG/M**2 | INFUSION | |||||||
| 127800241 | 12780024 | 5 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | UNK, CONTINUOUS INFUSION, 14 DAYS | Y | 0 | INFUSION | |||||||||
| 127800241 | 12780024 | 6 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | 3 MG/M2, DAYS 1-2 [6 CYCLES] | Y | 0 | 3 | MG/M**2 | INFUSION | |||||||
| 127800241 | 12780024 | 7 | SS | DOXORUBICIN | DOXORUBICIN | 1 | 20 MG/M2, DAYS 1-3 [6 CYCLES] | Y | 0 | 20 | MG/M**2 | ||||||||
| 127800241 | 12780024 | 8 | SS | ACTINOMYCIN D | DACTINOMYCIN | 1 | 0.75 MG/M2, DAY 1-2 [6 CYCLES] | Y | 0 | .75 | MG/M**2 | ||||||||
| 127800241 | 12780024 | 9 | SS | IRINOTECAN | IRINOTECAN | 1 | 10 MG/M2, DAYS 1-5 | Y | 0 | 10 | MG/M**2 | ||||||||
| 127800241 | 12780024 | 10 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | 100 MG/M2, DAY 1-5 | Y | 0 | 100 | MG/M**2 | ||||||||
| 127800241 | 12780024 | 11 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | 250 MG/M2, DAY 1-5 | Y | 0 | 250 | MG/M**2 | ||||||||
| 127800241 | 12780024 | 12 | SS | TOPOTECAN | TOPOTECANTOPOTECAN HYDROCHLORIDE | 1 | 0.75 MG/M2, DAY 1-5 | Y | 0 | .75 | MG/M**2 | ||||||||
| 127800241 | 12780024 | 13 | C | PREDNISOLONE. | PREDNISOLONE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127800241 | 12780024 | 1 | Ewing's sarcoma |
| 127800241 | 12780024 | 2 | Ewing's sarcoma |
| 127800241 | 12780024 | 4 | Ewing's sarcoma |
| 127800241 | 12780024 | 7 | Ewing's sarcoma |
| 127800241 | 12780024 | 8 | Ewing's sarcoma |
| 127800241 | 12780024 | 9 | Metastases to lung |
| 127800241 | 12780024 | 10 | Metastases to lung |
| 127800241 | 12780024 | 11 | Metastases to lung |
| 127800241 | 12780024 | 12 | Metastases to lung |
| 127800241 | 12780024 | 13 | Antiemetic supportive care |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127800241 | 12780024 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127800241 | 12780024 | Fracture | |
| 127800241 | 12780024 | Gait disturbance | |
| 127800241 | 12780024 | Osteonecrosis | |
| 127800241 | 12780024 | Pain in extremity | |
| 127800241 | 12780024 | Renal impairment |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |