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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125046072 | 12504607 | 2 | F | 2016 | 20160624 | 20160628 | 20160705 | EXP | US-SA-2016SA114038 | AVENTIS | 63.00 | YR | A | M | Y | 0.00000 | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125046072 | 12504607 | 1 | PS | LANTUS SOLOSTAR | INSULIN GLARGINE | 1 | Unknown | DOSE:56 UNIT(S) | U | UNK | 21081 | SOLUTION FOR INJECTION | QD | ||||||
| 125046072 | 12504607 | 2 | SS | LANTUS SOLOSTAR | INSULIN GLARGINE | 1 | Unknown | DOSE:40 UNIT(S) | U | 6F2774A | 21081 | SOLUTION FOR INJECTION | BID | ||||||
| 125046072 | 12504607 | 3 | SS | LANTUS SOLOSTAR | INSULIN GLARGINE | 1 | Unknown | DOSE:56 UNIT(S) | U | 6F2774A | 21081 | SOLUTION FOR INJECTION | QD | ||||||
| 125046072 | 12504607 | 4 | C | SOLOSTAR | DEVICE | 1 | UNK | 0 | QD | ||||||||||
| 125046072 | 12504607 | 5 | C | SOLOSTAR | DEVICE | 1 | 6F2774A | 0 | BID | ||||||||||
| 125046072 | 12504607 | 6 | C | SOLOSTAR | DEVICE | 1 | 6F2774A | 0 | QD | ||||||||||
| 125046072 | 12504607 | 7 | C | NOVOLOG | INSULIN ASPART | 1 | WITH MEALS DOSE:14 UNIT(S) | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125046072 | 12504607 | 1 | Type 2 diabetes mellitus |
| 125046072 | 12504607 | 2 | Type 2 diabetes mellitus |
| 125046072 | 12504607 | 3 | Type 2 diabetes mellitus |
| 125046072 | 12504607 | 4 | Type 2 diabetes mellitus |
| 125046072 | 12504607 | 5 | Type 2 diabetes mellitus |
| 125046072 | 12504607 | 6 | Type 2 diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125046072 | 12504607 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125046072 | 12504607 | Blood glucose increased | |
| 125046072 | 12504607 | Off label use | |
| 125046072 | 12504607 | Sialoadenitis |
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 |
|---|---|---|---|---|---|---|
| 125046072 | 12504607 | 2 | 20160615 | 0 | ||
| 125046072 | 12504607 | 3 | 20160518 | 0 | ||
| 125046072 | 12504607 | 5 | 20160615 | 0 | ||
| 125046072 | 12504607 | 6 | 20160518 | 0 |