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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125811711 | 12581171 | 1 | I | 201510 | 20160713 | 20160721 | 20160721 | EXP | FR-SA-2016SA129707 | AVENTIS | 59.00 | YR | A | M | Y | 0.00000 | 20160721 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125811711 | 12581171 | 1 | PS | LANTUS | INSULIN GLARGINE | 1 | Subcutaneous | Y | UNK | 21081 | 1 | DF | QD | ||||||
| 125811711 | 12581171 | 2 | C | MICARDIS PLUS | HYDROCHLOROTHIAZIDETELMISARTAN | 1 | STRENGTH: 80 MG/12.5 MG | 0 | TABLET | ||||||||||
| 125811711 | 12581171 | 3 | C | KALEORID | POTASSIUM CHLORIDE | 1 | FORM: PROLONGED RELEASE TABLET?STRENGTH: 1000MG | 0 | PROLONGED-RELEASE TABLET | ||||||||||
| 125811711 | 12581171 | 4 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | STRENGTH: 10MG | 0 | FILM-COATED TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125811711 | 12581171 | 1 | Type 2 diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125811711 | 12581171 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125811711 | 12581171 | Administration site erythema | |
| 125811711 | 12581171 | Injection site vesicles | |
| 125811711 | 12581171 | Malaise | |
| 125811711 | 12581171 | Nausea | |
| 125811711 | 12581171 | Pruritus generalised |
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 |
|---|---|---|---|---|---|---|
| 125811711 | 12581171 | 1 | 201510 | 20151221 | 0 |