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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125281901 | 12528190 | 1 | I | 20160621 | 20160705 | 20160705 | EXP | US-JNJFOC-20160621250 | JANSSEN | MCCONKEY DJ, CHOI W, SHEN Y, LEE IL, PORTEN S, MATIN SF, ET AL. A PROGNOSTIC GENE EXPRESSION SIGNATURE IN THE MOLECULAR CLASSIFICATION OF CHEMOTHERAPY-NAIVE UROTHELIAL CANCER IS PREDICTIVE OF CLINICAL OUTCOMES FROM NEOADJUVANT CHEMOTHERAPY: A PHASE 2 TRIAL OF DOSE-DENSE METHOTREXATE, VINBLASTINE, DOXORUBICIN, AND. EUR UROL 01-MAY-2016;69 (5):855-862. | 0.00 | Y | 0.00000 | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125281901 | 12528190 | 1 | PS | DOXORUBICIN | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | U | U | 50718 | 30 | MG/M**2 | LIPOSOME INJECTION | ||||||
| 125281901 | 12528190 | 2 | SS | BEVACIZUMAB | BEVACIZUMAB | 1 | Unknown | U | 0 | 10 | MG/KG | UNSPECIFIED | QOW | ||||||
| 125281901 | 12528190 | 3 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | U | 0 | 30 | MG/M**2 | UNSPECIFIED | |||||||
| 125281901 | 12528190 | 4 | SS | VINBLASTINE | VINBLASTINE | 1 | Unknown | U | 0 | 3 | MG/M**2 | UNSPECIFIED | |||||||
| 125281901 | 12528190 | 5 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | U | 0 | 70 | MG/M**2 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125281901 | 12528190 | 1 | Transitional cell carcinoma |
| 125281901 | 12528190 | 2 | Transitional cell carcinoma |
| 125281901 | 12528190 | 3 | Transitional cell carcinoma |
| 125281901 | 12528190 | 4 | Transitional cell carcinoma |
| 125281901 | 12528190 | 5 | Transitional cell carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125281901 | 12528190 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125281901 | 12528190 | Anaemia | |
| 125281901 | 12528190 | Fatigue | |
| 125281901 | 12528190 | Febrile neutropenia | |
| 125281901 | 12528190 | Hypertension | |
| 125281901 | 12528190 | Hyponatraemia | |
| 125281901 | 12528190 | Hypotension | |
| 125281901 | 12528190 | Mucosal inflammation | |
| 125281901 | 12528190 | Nausea | |
| 125281901 | 12528190 | Neutropenia | |
| 125281901 | 12528190 | Off label use | |
| 125281901 | 12528190 | Product use issue | |
| 125281901 | 12528190 | Pulmonary embolism | |
| 125281901 | 12528190 | Syncope | |
| 125281901 | 12528190 | Thrombocytopenia | |
| 125281901 | 12528190 | Thrombosis | |
| 125281901 | 12528190 | Transaminases increased | |
| 125281901 | 12528190 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |