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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125553631 | 12555363 | 1 | I | 20160629 | 20160714 | 20160714 | EXP | US-CIPLA LTD.-2016US09549 | CIPLA | WAGNER L, TURPIN B, NAGARAJAN R, WEISS B, CRIPE T, GELLAR J. 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125553631 | 12555363 | 1 | PS | Irinotecan | IRINOTECAN | 1 | Oral | 90 MG/M2/DAY ON DAYS 1 TO 5 OF EACH CYCLE | U | 0 | 90 | MG/M**2 | INJECTION | ||||||
| 125553631 | 12555363 | 2 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Unknown | 100 MG/M2/DAY ON DAYS 1 TO 5 OF EACH CYCLE | U | 0 | 100 | MG/M**2 | CAPSULE | ||||||
| 125553631 | 12555363 | 3 | SS | Vincristine | VINCRISTINE | 1 | Intravenous (not otherwise specified) | 1.5 MG/M2 (MAXIMUM DOSE: 2MG) OVER 1 MINUTE ON DAY 1 | U | 0 | 1.5 | MG/M**2 | |||||||
| 125553631 | 12555363 | 4 | SS | Bevacizumab | BEVACIZUMAB | 1 | Unknown | 15 MG/KG (MAXIMUM DOSE 800 MG),OVER 90 MINUTES ON DAY 1 | U | 0 | 15 | MG/KG | |||||||
| 125553631 | 12555363 | 5 | C | CEFIXIME. | CEFIXIME | 1 | Unknown | 8 MG/KG (MAXIMUM DOSE 400 MG), 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 |
|---|---|---|---|
| 125553631 | 12555363 | 1 | Adrenocortical carcinoma |
| 125553631 | 12555363 | 2 | Adrenocortical carcinoma |
| 125553631 | 12555363 | 3 | Adrenocortical carcinoma |
| 125553631 | 12555363 | 4 | Adrenocortical carcinoma |
| 125553631 | 12555363 | 5 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125553631 | 12555363 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125553631 | 12555363 | Disease progression |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |