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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125294883 | 12529488 | 3 | F | 20160704 | 20160706 | 20160713 | EXP | IT-ASTRAZENECA-2016SE71962 | ASTRAZENECA | 55.00 | YR | F | Y | 0.00000 | 20160713 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125294883 | 12529488 | 1 | PS | XIGDUO XR | DAPAGLIFLOZIN PROPANEDIOLMETFORMIN HYDROCHLORIDE | 1 | Oral | 269 | DF | Y | U | 205649 | 1 | DF | TABLET | QD | |||
| 125294883 | 12529488 | 2 | SS | DEPAGLIFLOZIN | DAPAGLIFLOZIN | 1 | Oral | Y | 0 | TABLET | |||||||||
| 125294883 | 12529488 | 3 | SS | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | NON AZ DRUG | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125294883 | 12529488 | 1 | Type 2 diabetes mellitus |
| 125294883 | 12529488 | 2 | Type 2 diabetes mellitus |
| 125294883 | 12529488 | 3 | Type 2 diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125294883 | 12529488 | HO |
| 125294883 | 12529488 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125294883 | 12529488 | Asthenia | |
| 125294883 | 12529488 | Blood creatinine increased | |
| 125294883 | 12529488 | Dehydration | |
| 125294883 | 12529488 | Diabetic metabolic decompensation | |
| 125294883 | 12529488 | Hyperkalaemia | |
| 125294883 | 12529488 | Hyponatraemia | |
| 125294883 | 12529488 | Malaise | |
| 125294883 | 12529488 | Nausea | |
| 125294883 | 12529488 | Polycythaemia | |
| 125294883 | 12529488 | Vertigo |
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 |
|---|---|---|---|---|---|---|
| 125294883 | 12529488 | 1 | 20151001 | 20160625 | 0 | |
| 125294883 | 12529488 | 2 | 201510 | 0 | ||
| 125294883 | 12529488 | 3 | 201510 | 0 |