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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 89228356 | 8922835 | 6 | F | 20160908 | 20121123 | 20160914 | EXP | US-ROCHE-1158446 | ROCHE | FEDERICO S, MCCARVILLE M, STEWART C, MAO S, WU J, DAVIDOFF A, FURMAN W, SANTANA V, PAPPO A AND NAVID F. PHASE I EXPANSION COHORT TO EVALUATE BEVACIZUMAB, SORAFENIB, AND LOW-DOSE CYCLOPHOSPHAMIDE IN CHILDREN AND YOUNG ADULTS WITH REFRACTORY OR RECURRENT SOLID TUMORS (ABSTRACT NUMBER: 10519).. JOURNAL OF CLINICAL ONCOLOGY 2016 MAY;34(SUPP15):-. | 0.00 | Y | 0.00000 | 20160914 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 89228356 | 8922835 | 1 | PS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | OVER 90 MINUTES WITH SUBSEQUENT DOSES OVER 60 MINUTES AND THEN 30 MINUTES IF TOLERATED. DOSE WAS ESC | U | 125085 | SOLUTION FOR INFUSION | ||||||||
| 89228356 | 8922835 | 2 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | EXPANSION STUDY, ON DAY 1 | U | 125085 | 15 | MG/KG | |||||||
| 89228356 | 8922835 | 3 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Oral | ADMINISTERED AS LIQUID OR TABLET. DOSE WAS ESCALATED. | U | 0 | |||||||||
| 89228356 | 8922835 | 4 | SS | SORAFENIB | SORAFENIB | 1 | Oral | ADMINISTERED AS A COMBINATION OF CAPSULES (COMPOUNDED FROM THE COMMERCIALLY AVAILABLE 200 MG TABLETS | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 89228356 | 8922835 | 1 | Leukaemia |
| 89228356 | 8922835 | 2 | Neoplasm |
| 89228356 | 8922835 | 3 | Neoplasm |
| 89228356 | 8922835 | 4 | Neoplasm |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 89228356 | 8922835 | OT |
| 89228356 | 8922835 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 89228356 | 8922835 | Anaemia | |
| 89228356 | 8922835 | Bladder pain | |
| 89228356 | 8922835 | Bladder spasm | |
| 89228356 | 8922835 | Cystitis haemorrhagic | |
| 89228356 | 8922835 | Decreased appetite | |
| 89228356 | 8922835 | Febrile neutropenia | |
| 89228356 | 8922835 | Hypertension | |
| 89228356 | 8922835 | Hypokalaemia | |
| 89228356 | 8922835 | Hyponatraemia | |
| 89228356 | 8922835 | Hypophosphataemia | |
| 89228356 | 8922835 | Lipase increased | |
| 89228356 | 8922835 | Lymphopenia | |
| 89228356 | 8922835 | Neutropenia | |
| 89228356 | 8922835 | Neutropenic infection | |
| 89228356 | 8922835 | Palmar-plantar erythrodysaesthesia syndrome | |
| 89228356 | 8922835 | Pneumothorax | |
| 89228356 | 8922835 | Rash | |
| 89228356 | 8922835 | Thrombocytopenia | |
| 89228356 | 8922835 | Thrombosis | |
| 89228356 | 8922835 | Vomiting | |
| 89228356 | 8922835 | Weight decreased | |
| 89228356 | 8922835 | White blood cell count decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |