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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103613539 | 10361353 | 9 | F | 20140115 | 20160908 | 20140805 | 20160918 | EXP | GB-ROCHE-1445081 | ROCHE | 71.68 | YR | M | Y | 92.00000 | KG | 20160919 | MD | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103613539 | 10361353 | 1 | PS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE PRIOR TO SAE: 24/APR/2014 AND 15/JAN/2014 | Y | UNKNOWN | 125085 | 462 | MG | SOLUTION FOR INFUSION | |||||
| 103613539 | 10361353 | 2 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE PRIOR TO SAE: 23/JUL/2014 | Y | UNKNOWN | 125085 | SOLUTION FOR INJECTION | |||||||
| 103613539 | 10361353 | 3 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | Y | UNKNOWN | 125085 | SOLUTION FOR INFUSION | ||||||||
| 103613539 | 10361353 | 4 | C | DALTEPARIN | DALTEPARIN | 1 | Unknown | 0 | 12500 | IU | |||||||||
| 103613539 | 10361353 | 5 | C | FOLINIC ACID | LEUCOVORIN | 1 | 0 | ||||||||||||
| 103613539 | 10361353 | 6 | C | 5-FU | FLUOROURACIL | 1 | 0 | ||||||||||||
| 103613539 | 10361353 | 7 | C | IRINOTECAN | IRINOTECAN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 103613539 | 10361353 | 1 | Colorectal adenocarcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 103613539 | 10361353 | HO |
| 103613539 | 10361353 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 103613539 | 10361353 | Cholelithiasis | |
| 103613539 | 10361353 | Intra-abdominal haematoma | |
| 103613539 | 10361353 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 103613539 | 10361353 | 1 | 20131227 | 20140501 | 0 | |
| 103613539 | 10361353 | 2 | 20140618 | 20140904 | 0 | |
| 103613539 | 10361353 | 3 | 20141126 | 0 | ||
| 103613539 | 10361353 | 4 | 20140306 | 0 |