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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125840401 | 12584040 | 1 | I | 20160520 | 20160718 | 20160722 | 20160722 | EXP | IT-MINISAL02-367564 | IT-MYLANLABS-2016M1030019 | MYLAN | 0.00 | Y | 0.00000 | 20160722 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125840401 | 12584040 | 1 | SS | GLICLAZIDE | GLICLAZIDE | 1 | Oral | 1 DF, QD | U | U | 0 | 1 | DF | TABLET | QD | ||||
| 125840401 | 12584040 | 2 | PS | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 1 DF, QD | U | U | 75973 | 1 | DF | TABLET | QD | ||||
| 125840401 | 12584040 | 3 | C | CARDIOASPIRIN | ASPIRIN | 1 | Oral | UNK | 0 | ||||||||||
| 125840401 | 12584040 | 4 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125840401 | 12584040 | 1 | Diabetes mellitus |
| 125840401 | 12584040 | 2 | Diabetes mellitus |
| 125840401 | 12584040 | 3 | Product used for unknown indication |
| 125840401 | 12584040 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125840401 | 12584040 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125840401 | 12584040 | Aphasia | |
| 125840401 | 12584040 | Confusional state | |
| 125840401 | 12584040 | Hypoglycaemia |
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 |
|---|---|---|---|---|---|---|
| 125840401 | 12584040 | 1 | 20160101 | 0 | ||
| 125840401 | 12584040 | 2 | 20160101 | 0 |