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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126710531 | 12671053 | 1 | I | 20120316 | 20160822 | 20160822 | EXP | US-CIPLA LTD.-2016US17204 | CIPLA | DUBOIS SG, CHESLER L, GROSHEN S, HAWKINS R, GOODARZIAN F, SHIMADA H, ET AL. PHASE I STUDY OF VINCRISTINE, IRINOTECAN, AND 131I-METAIODOBENZYLGUANIDINE FOR PATIENTS WITH RELAPSED OR REFRACTORY NEUROBLASTOMA: A NEW APPROACHES TO NEUROBLASTOMA THERAPY TRIAL. CLINICAL CANCER RESEARCH. 2012;18 (9):2679 TO 2686 | 0.00 | Y | 0.00000 | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126710531 | 12671053 | 1 | PS | Irinotecan | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 20 MG/M2, PER DOSE TO MAXIMUM DOSE OF 40 MG OVER 1 HOUR ON DAYS 0 TO 4 AND 7 TO 11 | U | U | 77219 | 20 | MG/M**2 | INFUSION | |||||
| 126710531 | 12671053 | 2 | SS | Vincristine | VINCRISTINE | 1 | Intravenous bolus | 1.5 MG/M2, PER DOSE TO MAXIMUM DOSE OF 2 MG ON DAYS 0 AND 7 | U | U | 0 | 1.5 | MG/M**2 | ||||||
| 126710531 | 12671053 | 3 | I | 131I-METAIODOBENZYLGUANIDINE | IOBENGUANE I-131 | 1 | Intravenous (not otherwise specified) | 8 MCI/KG, OVER 90 TO 120 MINUTES ON DAY 1 | U | U | 0 | INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126710531 | 12671053 | 1 | Neuroblastoma |
| 126710531 | 12671053 | 2 | Neuroblastoma |
| 126710531 | 12671053 | 3 | Neuroblastoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126710531 | 12671053 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126710531 | 12671053 | Bone marrow failure | |
| 126710531 | 12671053 | Drug interaction |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |