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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100108357 | 10010835 | 7 | F | 20160919 | 20140314 | 20160922 | EXP | US-ROCHE-1359891 | ROCHE | , HOFFMAN-CENSITS J, COHEN R, MAMTANI R, HEITJAN D, ELIASOF S, NIXON A, TURNBULL B, GARMEY E, GUNNARSSON O, WALIKI M, CICONTE J, JAYARAMAN L, SENDEROWICZ A, TELLEZ A, HENNESSY M, PISCITELLI A, VAUGHN D, SMITH A AND HAAS N. EFFICACY OF THE NANOPARTICLE-DRUG CONJUGATE CRLX101 IN COMBINATION WITH BEVACIZUMAB IN METASTATIC RENAL CELL CARCINOMA: RESULTS OF AN INVESTIGATOR-INITIATED PHASE I-IIA CLINICAL TRIAL. ANNALS OF ONCOLOGY 2016 AUG 01;27 (8):1579-1585. | 0.00 | Y | 0.00000 | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100108357 | 10010835 | 1 | PS | Bevacizumab | BEVACIZUMAB | 1 | Unknown | U | 125085 | 10 | MG/KG | QOW | |||||||
| 100108357 | 10010835 | 2 | SS | CRLX101 | INVESTIGATIONAL PRODUCT | 1 | Unknown | 12 MG/M2, 15 MG/M2: IN A STANDARD 3+3 DESIGN WITH AN EXPANSION AT THE RP2D | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 100108357 | 10010835 | 1 | Metastatic renal cell carcinoma |
| 100108357 | 10010835 | 2 | Metastatic renal cell carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 100108357 | 10010835 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 100108357 | 10010835 | Abdominal pain | |
| 100108357 | 10010835 | Anaemia | |
| 100108357 | 10010835 | Cystitis noninfective | |
| 100108357 | 10010835 | Dehydration | |
| 100108357 | 10010835 | Dental caries | |
| 100108357 | 10010835 | Diarrhoea | |
| 100108357 | 10010835 | Dizziness | |
| 100108357 | 10010835 | Fatigue | |
| 100108357 | 10010835 | Hypertension | |
| 100108357 | 10010835 | Nausea | |
| 100108357 | 10010835 | Neutropenia | |
| 100108357 | 10010835 | Oedema | |
| 100108357 | 10010835 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |