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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127498191 | 12749819 | 1 | I | 20160911 | 0 | 20160915 | 20160915 | DIR | US-FDA-350722 | FDA-CTU | 61.00 | YR | F | N | 73.90000 | KG | 20160915 | N | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127498191 | 12749819 | 1 | PS | JANUMET | METFORMIN HYDROCHLORIDESITAGLIPTIN PHOSPHATE | 1 | Oral | Y | D | 0 | BID | ||||||||
| 127498191 | 12749819 | 2 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | 0 | ||||||||||||
| 127498191 | 12749819 | 4 | C | ATORVASTATIN | ATORVASTATIN | 1 | 0 | ||||||||||||
| 127498191 | 12749819 | 6 | C | CLONIDINE. | CLONIDINE | 1 | 0 | ||||||||||||
| 127498191 | 12749819 | 8 | C | EMPAGLIFOZIN | 2 | 0 | |||||||||||||
| 127498191 | 12749819 | 10 | C | GLIMEPIRIDE. | GLIMEPIRIDE | 1 | 0 | ||||||||||||
| 127498191 | 12749819 | 12 | C | ISONIAZID. | ISONIAZID | 1 | 0 | ||||||||||||
| 127498191 | 12749819 | 14 | C | PIOGLITAZONE. | PIOGLITAZONE | 1 | 0 | ||||||||||||
| 127498191 | 12749819 | 16 | C | TELMISARTAN. | TELMISARTAN | 1 | 0 | ||||||||||||
| 127498191 | 12749819 | 18 | C | HCTZ | HYDROCHLOROTHIAZIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127498191 | 12749819 | 1 | Type 2 diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127498191 | 12749819 | OT |
| 127498191 | 12749819 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127498191 | 12749819 | Lactic acidosis | |
| 127498191 | 12749819 | Pancreatitis | |
| 127498191 | 12749819 | Renal failure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | CASEID | RPSR COD |
|---|---|---|
| 127498191 | 12749819 | HP |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 127498191 | 12749819 | 1 | 20160304 | 20160911 | 0 |