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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125396063 | 12539606 | 3 | F | 20160318 | 20160715 | 20160708 | 20160727 | EXP | 365087 | IT-ACCORD-042178 | ACCORD | 63.00 | YR | M | Y | 64.00000 | KG | 20160727 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125396063 | 12539606 | 1 | PS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous bolus | PATIENT ALSO RECEIVED 5-FU 3200 MG INTRAVENOUS FROM 22-APR-2016 TO 03-JUN-2016 | 40743 | 540 | MG | SOLUTION FOR INFUSION | |||||||
| 125396063 | 12539606 | 2 | SS | CAPECITABINE. | CAPECITABINE | 1 | Oral | 202593 | 3000 | MG | TABLET | ||||||||
| 125396063 | 12539606 | 3 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous (not otherwise specified) | 200750096 | 160 | MG | SOLUTION FOR INFUSION | ||||||||
| 125396063 | 12539606 | 4 | C | LEDERFOLIN | LEUCOVORIN CALCIUM | 1 | 0 | 270 | MG | SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125396063 | 12539606 | 1 | Adenocarcinoma gastric |
| 125396063 | 12539606 | 2 | Adenocarcinoma gastric |
| 125396063 | 12539606 | 3 | Adenocarcinoma gastric |
| 125396063 | 12539606 | 4 | Adenocarcinoma gastric |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125396063 | 12539606 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125396063 | 12539606 | Neutropenia | |
| 125396063 | 12539606 | Off label use | |
| 125396063 | 12539606 | Paraesthesia | |
| 125396063 | 12539606 | Supraventricular extrasystoles | |
| 125396063 | 12539606 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 125396063 | 12539606 | 1 | 20160422 | 20160603 | 0 | |
| 125396063 | 12539606 | 2 | 20160302 | 20160302 | 0 | |
| 125396063 | 12539606 | 3 | 20160302 | 20160603 | 0 | |
| 125396063 | 12539606 | 4 | 20160422 | 20160603 | 0 |