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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125111622 | 12511162 | 2 | F | 2016 | 20160718 | 20160629 | 20160727 | EXP | US-SA-2016SA116919 | AVENTIS | 69.00 | YR | E | F | Y | 0.00000 | 20160727 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125111622 | 12511162 | 1 | PS | LANTUS SOLOSTAR | INSULIN GLARGINE | 1 | Unknown | DOSE:45 UNIT(S) | 6F2682A | 21081 | SOLUTION FOR INJECTION | QD | |||||||
| 125111622 | 12511162 | 2 | SS | SOLOSTAR | DEVICE | 1 | 6F2682A | 0 | QD | ||||||||||
| 125111622 | 12511162 | 3 | C | LEVEMIR | INSULIN DETEMIR | 1 | 0 | ||||||||||||
| 125111622 | 12511162 | 4 | C | FLEXPEN | UNSPECIFIED INGREDIENT | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125111622 | 12511162 | 1 | Type 2 diabetes mellitus |
| 125111622 | 12511162 | 2 | Type 2 diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125111622 | 12511162 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125111622 | 12511162 | Device issue | |
| 125111622 | 12511162 | Diabetic ketoacidosis | |
| 125111622 | 12511162 | Injection site pain | |
| 125111622 | 12511162 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 125111622 | 12511162 | 1 | 20160511 | 0 | ||
| 125111622 | 12511162 | 2 | 20160511 | 0 |