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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107918262 | 10791826 | 2 | F | 20160805 | 20150213 | 20160819 | EXP | US-CIPLA LTD.-2015US00966 | CIPLA | DUBOIS SG, ALLEN A, BENT M, HILTON J.F, HOLLINGER F, HAWKINS R ET.AL.. PHASE I/II STUDY OF 131I-MIBG WITH VINCRISTINE AND 5 DAYS OF IRINOTECAN FOR ADVANCED NEUROBLASTOMA. BRITISH JOURNAL OF CANCER. 2015;112 (4):1-6 | 0.00 | Y | 0.00000 | 20160819 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107918262 | 10791826 | 1 | PS | Irinotecan | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 50 MG/M2, OVER 60-90 MINS ON DAYS 0-4 | U | U | 0 | 50 | MG/M**2 | INFUSION | |||||
| 107918262 | 10791826 | 2 | SS | Vincristine | VINCRISTINE | 1 | Intravenous (not otherwise specified) | 2 MG/M2, ,BOLUS ON DAY 0 | U | U | 0 | 2 | MG/M**2 | ||||||
| 107918262 | 10791826 | 3 | SS | I-Metaiodobenzylguanidine | IOBENGUANE | 1 | Intravenous (not otherwise specified) | 555 OR 666 MBQ/KG ON DAY 1 | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 107918262 | 10791826 | 1 | Neuroblastoma |
| 107918262 | 10791826 | 2 | Neuroblastoma |
| 107918262 | 10791826 | 3 | Neuroblastoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 107918262 | 10791826 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 107918262 | 10791826 | Disease progression |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |