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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126838153 | 12683815 | 3 | F | 20160802 | 20160912 | 20160825 | 20160922 | EXP | NO-TEVA-684747ACC | TEVA | 56.00 | YR | M | Y | 0.00000 | 20160922 | OT | NO | NO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126838153 | 12683815 | 1 | PS | CALCIUM FOLINATE | LEUCOVORIN CALCIUM | 1 | Intravenous (not otherwise specified) | U | 71198 | 100 | MG | ||||||||
| 126838153 | 12683815 | 2 | SS | OXALIPLATIN 5mg/ml CONCENTRATE FOR SOLUTION FOR INFUSION | OXALIPLATIN | 1 | Intravenous (not otherwise specified) | U | U | 0 | 153 | MG | SOLUTION FOR INFUSION | ||||||
| 126838153 | 12683815 | 3 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | U | 0 | 900 | MG | |||||||||
| 126838153 | 12683815 | 4 | SS | FLUOROBLASTIN | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | U | 0 | 900 | MG | ||||||||
| 126838153 | 12683815 | 5 | SS | FLUOROBLASTIN | FLUOROURACIL | 1 | U | 0 | 900 | MG | |||||||||
| 126838153 | 12683815 | 6 | SS | FLUOROBLASTIN | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | U | 0 | 900 | MG | ||||||||
| 126838153 | 12683815 | 7 | C | EMEND | APREPITANT | 1 | Oral | 0 | 125 | MG | |||||||||
| 126838153 | 12683815 | 8 | C | ONDANSETRON | ONDANSETRON | 1 | 0 | 8 | MG | ||||||||||
| 126838153 | 12683815 | 9 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 0 | 16 | MG | |||||||||
| 126838153 | 12683815 | 10 | C | KLEXANE | ENOXAPARIN | 1 | Subcutaneous | 0 | 60 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126838153 | 12683815 | 1 | Rectal cancer |
| 126838153 | 12683815 | 2 | Rectal cancer |
| 126838153 | 12683815 | 3 | Rectal cancer |
| 126838153 | 12683815 | 4 | Rectal cancer |
| 126838153 | 12683815 | 7 | Prophylaxis of nausea and vomiting |
| 126838153 | 12683815 | 8 | Premedication |
| 126838153 | 12683815 | 9 | Premedication |
| 126838153 | 12683815 | 10 | Deep vein thrombosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126838153 | 12683815 | OT |
| 126838153 | 12683815 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126838153 | 12683815 | Abdominal pain upper | |
| 126838153 | 12683815 | Hyperhidrosis | |
| 126838153 | 12683815 | Nausea | |
| 126838153 | 12683815 | Restlessness |
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 |
|---|---|---|---|---|---|---|
| 126838153 | 12683815 | 1 | 20160802 | 0 | ||
| 126838153 | 12683815 | 2 | 20160802 | 0 | ||
| 126838153 | 12683815 | 3 | 20150802 | 0 | ||
| 126838153 | 12683815 | 4 | 20160704 | 0 | ||
| 126838153 | 12683815 | 5 | 20160802 | 0 | ||
| 126838153 | 12683815 | 6 | 20160705 | 0 |