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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 94018115 | 9401811 | 5 | F | 20160804 | 20130716 | 20160812 | EXP | US-SANOFI-AVENTIS-2013SA070514 | AVENTIS | 60.00 | YR | A | M | Y | 0.00000 | 20160812 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 94018115 | 9401811 | 1 | PS | LANTUS SOLOSTAR | INSULIN GLARGINE | 1 | Unknown | DOSE:15 UNIT(S) | 5F2268A | 21081 | QD | ||||||||
| 94018115 | 9401811 | 2 | SS | APIDRA SOLOSTAR | INSULIN GLULISINE | 1 | Unknown | N | UNKNOWN | 21629 | |||||||||
| 94018115 | 9401811 | 3 | SS | APIDRA SOLOSTAR | INSULIN GLULISINE | 1 | Unknown | N | UNK | 21629 | |||||||||
| 94018115 | 9401811 | 4 | C | SOLOSTAR | DEVICE | 1 | 0 | ||||||||||||
| 94018115 | 9401811 | 5 | C | SOLOSTAR | DEVICE | 1 | UNK | 0 | |||||||||||
| 94018115 | 9401811 | 6 | C | SOLOSTAR | DEVICE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 94018115 | 9401811 | 1 | Type 1 diabetes mellitus |
| 94018115 | 9401811 | 2 | Diabetes mellitus |
| 94018115 | 9401811 | 3 | Diabetes mellitus |
| 94018115 | 9401811 | 5 | Diabetes mellitus |
| 94018115 | 9401811 | 6 | Diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 94018115 | 9401811 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 94018115 | 9401811 | Blood glucose fluctuation | |
| 94018115 | 9401811 | Cardiac arrest | |
| 94018115 | 9401811 | Diabetic neuropathy | |
| 94018115 | 9401811 | Drug dose omission | |
| 94018115 | 9401811 | Fungal skin infection | |
| 94018115 | 9401811 | Hyperglycaemia | |
| 94018115 | 9401811 | Hypoacusis | |
| 94018115 | 9401811 | Hypoglycaemia | |
| 94018115 | 9401811 | Loose tooth | |
| 94018115 | 9401811 | Loss of consciousness | |
| 94018115 | 9401811 | Neoplasm malignant | |
| 94018115 | 9401811 | Visual acuity reduced |
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 |
|---|---|---|---|---|---|---|
| 94018115 | 9401811 | 1 | 2004 | 20160803 | 0 | |
| 94018115 | 9401811 | 3 | 201603 | 0 | ||
| 94018115 | 9401811 | 4 | 2004 | 20160803 | 0 | |
| 94018115 | 9401811 | 5 | 201603 | 0 |