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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125734071 | 12573407 | 1 | I | 20160718 | 20160720 | 20160720 | EXP | ES-ROCHE-1797225 | ROCHE | PERICAY C, SERRA-ARACIL X, OCANA-ROJAS J, MORA-LOPEZ L, DOTOR E, CASALOTS A, PISA A AND SAIGI E. FURTHER EVIDENCE FOR PREOPERATIVE CHEMORADIOTHERAPY AND TRANSANAL ENDOSCOPIC SURGERY (TEM) IN T2-3S,N0,M0 RECTAL CANCER.. CLINICAL AND TRANSLATIONAL ONCOLOGY. 2016 JUL 01;18.7:666-671. | 0.00 | Y | 0.00000 | 20160720 | OT | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125734071 | 12573407 | 1 | PS | CAPECITABINE. | CAPECITABINE | 1 | Oral | U | 20896 | 825 | MG/M**2 | TABLET | BID | ||||||
| 125734071 | 12573407 | 2 | SS | 5-FLUOROURACIL | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | 300 MG/M2 A DAY, 5 DAYS A WEEK FOR 5 WEEKS | U | 0 | 300 | MG/M**2 | INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125734071 | 12573407 | 1 | Rectal adenocarcinoma |
| 125734071 | 12573407 | 2 | Rectal adenocarcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125734071 | 12573407 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125734071 | 12573407 | Abdominal pain | |
| 125734071 | 12573407 | Asthenia | |
| 125734071 | 12573407 | Cystitis | |
| 125734071 | 12573407 | Decreased appetite | |
| 125734071 | 12573407 | Dermatitis | |
| 125734071 | 12573407 | Diarrhoea | |
| 125734071 | 12573407 | Mucosal inflammation | |
| 125734071 | 12573407 | Proctalgia | |
| 125734071 | 12573407 | Proctitis | |
| 125734071 | 12573407 | Rectal haemorrhage | |
| 125734071 | 12573407 | Renal failure | |
| 125734071 | 12573407 | Thrombocytopenia | |
| 125734071 | 12573407 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |