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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125221313 | 12522131 | 3 | F | 20140423 | 20160714 | 20160701 | 20160722 | EXP | US-SA-2016SA118045 | AVENTIS | 56.00 | YR | A | F | Y | 0.00000 | 20160722 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125221313 | 12522131 | 1 | PS | LANTUS SOLOSTAR | INSULIN GLARGINE | 1 | Unknown | 22 UNITS AM AND 24-26 UNITS PM | U | 5F2400A | 21081 | SOLUTION FOR INJECTION | BID | ||||||
| 125221313 | 12522131 | 2 | SS | LANTUS SOLOSTAR | INSULIN GLARGINE | 1 | Unknown | WRONG DOSE ADMINISTERED | U | 5F2400A | 21081 | SOLUTION FOR INJECTION | 1X | ||||||
| 125221313 | 12522131 | 3 | SS | LANTUS SOLOSTAR | INSULIN GLARGINE | 1 | Unknown | U | 5F2400A | 21081 | SOLUTION FOR INJECTION | ||||||||
| 125221313 | 12522131 | 4 | SS | LANTUS SOLOSTAR | INSULIN GLARGINE | 1 | Unknown | 22 UNITS AM AND 24-26 UNITS PM | U | 5F1321A | 21081 | SOLUTION FOR INJECTION | BID | ||||||
| 125221313 | 12522131 | 5 | SS | LANTUS SOLOSTAR | INSULIN GLARGINE | 1 | Unknown | WRONG DOSE ADMINISTERED | U | 5F1321A | 21081 | SOLUTION FOR INJECTION | 1X | ||||||
| 125221313 | 12522131 | 6 | SS | LANTUS SOLOSTAR | INSULIN GLARGINE | 1 | Unknown | U | 5F1321A | 21081 | SOLUTION FOR INJECTION | ||||||||
| 125221313 | 12522131 | 7 | SS | SOLOSTAR | DEVICE | 1 | U | 5F2400A | 0 | BID | |||||||||
| 125221313 | 12522131 | 8 | SS | SOLOSTAR | DEVICE | 1 | U | 5F1321A | 0 | BID | |||||||||
| 125221313 | 12522131 | 9 | SS | SOLOSTAR | DEVICE | 1 | U | 5F2400A | 0 | 1X | |||||||||
| 125221313 | 12522131 | 10 | SS | SOLOSTAR | DEVICE | 1 | U | 5F1321A | 0 | 1X | |||||||||
| 125221313 | 12522131 | 11 | SS | SOLOSTAR | DEVICE | 1 | U | 5F2400A | 0 | ||||||||||
| 125221313 | 12522131 | 12 | SS | SOLOSTAR | DEVICE | 1 | U | 5F1321A | 0 | ||||||||||
| 125221313 | 12522131 | 13 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125221313 | 12522131 | 1 | Type 1 diabetes mellitus |
| 125221313 | 12522131 | 2 | Type 1 diabetes mellitus |
| 125221313 | 12522131 | 3 | Type 1 diabetes mellitus |
| 125221313 | 12522131 | 4 | Type 1 diabetes mellitus |
| 125221313 | 12522131 | 5 | Type 1 diabetes mellitus |
| 125221313 | 12522131 | 6 | Type 1 diabetes mellitus |
| 125221313 | 12522131 | 7 | Type 1 diabetes mellitus |
| 125221313 | 12522131 | 8 | Type 1 diabetes mellitus |
| 125221313 | 12522131 | 9 | Type 1 diabetes mellitus |
| 125221313 | 12522131 | 10 | Type 1 diabetes mellitus |
| 125221313 | 12522131 | 11 | Type 1 diabetes mellitus |
| 125221313 | 12522131 | 12 | Type 1 diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125221313 | 12522131 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125221313 | 12522131 | Blood glucose increased | |
| 125221313 | 12522131 | Device issue | |
| 125221313 | 12522131 | Incorrect dose administered | |
| 125221313 | 12522131 | Pharyngeal oedema | |
| 125221313 | 12522131 | Product use issue | |
| 125221313 | 12522131 | Thyroid disorder |
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 |
|---|---|---|---|---|---|---|
| 125221313 | 12522131 | 1 | 20140423 | 201606 | 0 | |
| 125221313 | 12522131 | 2 | 201606 | 201606 | 0 | |
| 125221313 | 12522131 | 3 | 201606 | 0 | ||
| 125221313 | 12522131 | 4 | 20140423 | 201606 | 0 | |
| 125221313 | 12522131 | 5 | 201606 | 201606 | 0 | |
| 125221313 | 12522131 | 6 | 201606 | 0 | ||
| 125221313 | 12522131 | 7 | 20140423 | 201606 | 0 | |
| 125221313 | 12522131 | 8 | 20140423 | 201606 | 0 | |
| 125221313 | 12522131 | 9 | 201606 | 201606 | 0 | |
| 125221313 | 12522131 | 10 | 201606 | 201606 | 0 | |
| 125221313 | 12522131 | 11 | 201606 | 0 | ||
| 125221313 | 12522131 | 12 | 201606 | 0 |