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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125542492 | 12554249 | 2 | F | 20160705 | 20160713 | 20160714 | EXP | US-SANOFI-AVENTIS-2012SA076073 | AVENTIS | 73.00 | YR | E | M | Y | 0.00000 | 20160714 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125542492 | 12554249 | 1 | PS | LANTUS SOLOSTAR | INSULIN GLARGINE | 1 | Subcutaneous | TREATMENT START DATE: 4-5 YEARS DOSE:22 UNIT(S) | 2F936A | 21081 | SOLUTION FOR INJECTION | QD | |||||||
| 125542492 | 12554249 | 2 | C | SOLOSTAR | DEVICE | 1 | 2F936A | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125542492 | 12554249 | 1 | Diabetes mellitus |
| 125542492 | 12554249 | 2 | Type 2 diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125542492 | 12554249 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125542492 | 12554249 | Cerebrovascular accident | |
| 125542492 | 12554249 | Injection site nodule | |
| 125542492 | 12554249 | Irritability |
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 |
|---|---|---|---|---|---|---|
| 125542492 | 12554249 | 2 | 201112 | 0 |