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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126132401 | 12613240 | 1 | I | 20160422 | 20160627 | 20160802 | 20160802 | EXP | 364745 | IT-ACCORD-042077 | ACCORD | 54.00 | YR | F | Y | 58.00000 | KG | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126132401 | 12613240 | 1 | PS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | 40743 | 4290 | DF | SOLUTION FOR INFUSION | ||||||||
| 126132401 | 12613240 | 2 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous (not otherwise specified) | 200750096 | 140 | MG | SOLUTION FOR INFUSION | ||||||||
| 126132401 | 12613240 | 3 | SS | TAXOTERE | DOCETAXEL | 1 | Intravenous (not otherwise specified) | 0 | 80 | MG | SOLUTION FOR INFUSION | ||||||||
| 126132401 | 12613240 | 4 | SS | TRASTUZUMAB | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 0 | 230 | MG | SOLUTION FOR INFUSION | ||||||||
| 126132401 | 12613240 | 5 | C | FOLINIC ACID | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | 0 | 330 | MG | SOLUTION FOR INFUSION | ||||||||
| 126132401 | 12613240 | 6 | C | ESOMEPRAZOLE | ESOMEPRAZOLE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126132401 | 12613240 | 1 | Oesophageal adenocarcinoma |
| 126132401 | 12613240 | 2 | Oesophageal adenocarcinoma |
| 126132401 | 12613240 | 3 | Oesophageal adenocarcinoma |
| 126132401 | 12613240 | 4 | Oesophageal adenocarcinoma |
| 126132401 | 12613240 | 5 | Oesophageal adenocarcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126132401 | 12613240 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126132401 | 12613240 | Alopecia totalis | |
| 126132401 | 12613240 | Anaemia | |
| 126132401 | 12613240 | Dysgeusia | |
| 126132401 | 12613240 | Hypertransaminasaemia | |
| 126132401 | 12613240 | Nausea | |
| 126132401 | 12613240 | Off label use | |
| 126132401 | 12613240 | Paraesthesia |
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 |
|---|---|---|---|---|---|---|
| 126132401 | 12613240 | 1 | 20160418 | 0 | ||
| 126132401 | 12613240 | 2 | 20160418 | 0 | ||
| 126132401 | 12613240 | 3 | 20160418 | 0 | ||
| 126132401 | 12613240 | 4 | 20160418 | 0 | ||
| 126132401 | 12613240 | 5 | 20160418 | 20160530 | 0 |