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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106617304 | 10661730 | 4 | F | 20141205 | 20160804 | 20141218 | 20160811 | EXP | PHHO2014US016629 | SANDOZ | 57.88 | YR | F | Y | 62.13000 | KG | 20160811 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106617304 | 10661730 | 1 | PS | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 1000 MG, QD | U | 75985 | 1000 | MG | QD | ||||||
| 106617304 | 10661730 | 2 | SS | COMPARATOR CAPECITABINE | CAPECITABINE | 1 | Oral | 1500 MG, BID | 66000 | MG | U | 0 | 1500 | MG | TABLET | BID | |||
| 106617304 | 10661730 | 3 | SS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Oral | 15 MG, BID | 660 | MG | U | 0 | 15 | MG | BID | ||||
| 106617304 | 10661730 | 4 | SS | BENICAR | OLMESARTAN MEDOXOMIL | 1 | Oral | 20 MG, QD | U | 0 | 20 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 106617304 | 10661730 | 1 | Diabetes mellitus |
| 106617304 | 10661730 | 2 | Pancreatic carcinoma metastatic |
| 106617304 | 10661730 | 3 | Pancreatic carcinoma metastatic |
| 106617304 | 10661730 | 4 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 106617304 | 10661730 | DE |
| 106617304 | 10661730 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 106617304 | 10661730 | Acute kidney injury |
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 |
|---|---|---|---|---|---|---|
| 106617304 | 10661730 | 1 | 2004 | 20141205 | 0 | |
| 106617304 | 10661730 | 2 | 20141113 | 20141204 | 0 | |
| 106617304 | 10661730 | 3 | 20141113 | 20141204 | 0 | |
| 106617304 | 10661730 | 4 | 2004 | 20141205 | 0 |