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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125554521 | 12555452 | 1 | I | 20160629 | 20160714 | 20160714 | EXP | US-CIPLA LTD.-2016US09550 | CIPLA | WAGNER L, TURPIN B, NAGARAJAN R, WEISS B, CRIPE T, GELLER J ET.AL. PILOT STUDY OF VINCRISTINE, ORAL IRINOTECAN, AND TEMOZOLOMIDE (VOIT REGIMEN) COMBINED WITH BEVACIZUMAB IN PEDIATRIC PATIENTS WITH RECURRENT SOLID TUMORS OR BRAIN TUMORS. PEDIATR BLOOD CANCER. 2013;60:1447 TO 1451 | 0.00 | Y | 0.00000 | 20160714 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125554521 | 12555452 | 1 | PS | Irinotecan | IRINOTECAN | 1 | Oral | 90 MG/M2, QD, ON DAYS 1-5 | U | 77219 | 90 | MG/M**2 | |||||||
| 125554521 | 12555452 | 2 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Unknown | 150 MG/M2/DAY ON DAYS 1-5 | U | 0 | 150 | MG/M**2 | CAPSULE | ||||||
| 125554521 | 12555452 | 3 | SS | Vincristine | VINCRISTINE | 1 | Intravenous (not otherwise specified) | 1.5 MG/M2, OVER 1 MINUTE ON DAY 1 MAXIMUM 2 MG | U | U | 0 | 1.5 | MG/M**2 | ||||||
| 125554521 | 12555452 | 4 | SS | Bevacizumab | BEVACIZUMAB | 1 | Unknown | 15 MG/KG, OVER 90 MINUTES ON DAY 1 | U | U | 0 | 15 | MG/KG | ||||||
| 125554521 | 12555452 | 5 | C | CEFIXIME. | CEFIXIME | 1 | Unknown | 8 MG/KG, ADMINISTERED FOR 10 DAYS STARTING 2 DAYS BEFORE EACH CHEMOTHERAPY CYCLE. | U | U | 0 | 8 | MG/KG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125554521 | 12555452 | 1 | Ewing's sarcoma |
| 125554521 | 12555452 | 2 | Ewing's sarcoma |
| 125554521 | 12555452 | 3 | Ewing's sarcoma |
| 125554521 | 12555452 | 4 | Ewing's sarcoma |
| 125554521 | 12555452 | 5 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125554521 | 12555452 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125554521 | 12555452 | Bone marrow failure | |
| 125554521 | 12555452 | Recurrent cancer |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |