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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126301992 | 12630199 | 2 | F | 2013 | 20160812 | 20160808 | 20160818 | EXP | PH-009507513-1607PHL012642 | MERCK | 57.00 | YR | F | Y | 0.00000 | 20160818 | CN | PH | PH |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126301992 | 12630199 | 1 | PS | JANUMET | METFORMIN HYDROCHLORIDESITAGLIPTIN PHOSPHATE | 1 | Oral | 50/500 MG (ONE TABLET), ONCE DAILY (OD) IN THE MORNING | 22044 | 1 | DF | FILM-COATED TABLET | QD | ||||||
| 126301992 | 12630199 | 2 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 126301992 | 12630199 | 3 | C | ROSUVASTATIN. | ROSUVASTATIN | 1 | UNK | 0 | |||||||||||
| 126301992 | 12630199 | 4 | C | ESSENTIALE FORTE (phospholipids (unspecified)) | 2 | UNK | 0 | ||||||||||||
| 126301992 | 12630199 | 5 | C | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | UNK, TID | 0 | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126301992 | 12630199 | 1 | Diabetes mellitus |
| 126301992 | 12630199 | 3 | Blood cholesterol increased |
| 126301992 | 12630199 | 4 | Routine health maintenance |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126301992 | 12630199 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126301992 | 12630199 | Abdominal pain upper | |
| 126301992 | 12630199 | Faeces soft | |
| 126301992 | 12630199 | Gastrointestinal motility disorder | |
| 126301992 | 12630199 | Haematochezia | |
| 126301992 | 12630199 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 126301992 | 12630199 | 1 | 2013 | 0 | ||
| 126301992 | 12630199 | 5 | 20160805 | 0 |