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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127833001 | 12783300 | 1 | I | 20160919 | 20160927 | 20160927 | EXP | JP-ROCHE-1834414 | ROCHE | , YAMAZAKI K, NAGASE M, TAMAGAWA H, UEDA S, TAMURA T, MURATA K, NAKAJIMA T, BABA E, TSUDA M, MORIWAKI T, ESAKI T, TSUJI Y, MURO K, TAIRA K, DENDA T, FUNAI S, SHINOZAKI K, YAMASHITA H, SUGIMOTO N, OKUNO T, NISHINA T, UMEKI M, KURIMOTO T, ET EL RANDOMIZED PHASE III STUDY OF BEVACIZUMAB PLUS FOLFIRI AND BEVACIZUMAB PLUS MFOLFOX6 AS FIRST-LINE TREATMENT FOR PATIENTS WITH METASTATIC COLORECTAL CANCER (WJOG4407G). ANNALS OF ONCOLOGY 2016 AUG 01;27 (8):1539-1546. | 0.00 | Y | 0.00000 | 20160927 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127833001 | 12783300 | 1 | PS | Bevacizumab | BEVACIZUMAB | 1 | Unknown | ON DAY 1 OF 14 DAYS CYCLE | U | 125085 | 5 | MG/KG | |||||||
| 127833001 | 12783300 | 2 | SS | IRINOTECAN | IRINOTECAN | 1 | Unknown | U | 0 | 150 | MG/M**2 | ||||||||
| 127833001 | 12783300 | 3 | SS | L-LEUCOVORIN | LEUCOVORIN | 1 | Unknown | U | 0 | 200 | MG/M**2 | ||||||||
| 127833001 | 12783300 | 4 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous bolus | U | 0 | 400 | MG/M**2 | ||||||||
| 127833001 | 12783300 | 5 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Unknown | CONTINUOUS INFUSION | U | 0 | 2400 | MG/M**2 | |||||||
| 127833001 | 12783300 | 6 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Unknown | U | 0 | 85 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127833001 | 12783300 | 1 | Colorectal cancer metastatic |
| 127833001 | 12783300 | 2 | Colorectal cancer metastatic |
| 127833001 | 12783300 | 3 | Colorectal cancer metastatic |
| 127833001 | 12783300 | 4 | Colorectal cancer metastatic |
| 127833001 | 12783300 | 6 | Colorectal cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127833001 | 12783300 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127833001 | 12783300 | Abdominal pain | |
| 127833001 | 12783300 | Anaemia | |
| 127833001 | 12783300 | Decreased appetite | |
| 127833001 | 12783300 | Diarrhoea | |
| 127833001 | 12783300 | Embolism arterial | |
| 127833001 | 12783300 | Embolism venous | |
| 127833001 | 12783300 | Fatigue | |
| 127833001 | 12783300 | Febrile neutropenia | |
| 127833001 | 12783300 | Gastrointestinal haemorrhage | |
| 127833001 | 12783300 | Gastrointestinal perforation | |
| 127833001 | 12783300 | Hypertension | |
| 127833001 | 12783300 | Ileus paralytic | |
| 127833001 | 12783300 | Leukopenia | |
| 127833001 | 12783300 | Mucosal inflammation | |
| 127833001 | 12783300 | Nausea | |
| 127833001 | 12783300 | Neutropenia | |
| 127833001 | 12783300 | Palmar-plantar erythrodysaesthesia syndrome | |
| 127833001 | 12783300 | Peripheral sensory neuropathy | |
| 127833001 | 12783300 | Pneumonitis | |
| 127833001 | 12783300 | Pyrexia | |
| 127833001 | 12783300 | Thrombocytopenia | |
| 127833001 | 12783300 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |