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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115384578 | 11538457 | 8 | F | 20140225 | 20160712 | 20150922 | 20160715 | EXP | JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2015-BI-41079NB | BOEHRINGER INGELHEIM | 60.76 | YR | M | Y | 55.00000 | KG | 20160715 | MD | COUNTRY NOT SPECIFIED | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115384578 | 11538457 | 1 | PS | TRAZENTA | LINAGLIPTIN | 1 | Oral | 5 MG | Y | 201280 | 5 | MG | TABLET | QD | |||||
| 115384578 | 11538457 | 2 | SS | LANTUS | INSULIN GLARGINE | 1 | Subcutaneous | 6 U | Y | 0 | 6 | IU | INJECTION | QD | |||||
| 115384578 | 11538457 | 3 | SS | SOVALDI | SOFOSBUVIR | 1 | Oral | 400 MG | Y | 0 | 400 | MG | QD | ||||||
| 115384578 | 11538457 | 4 | SS | REBETOL | RIBAVIRIN | 1 | Oral | 600 MG | Y | 0 | 600 | MG | QD | ||||||
| 115384578 | 11538457 | 5 | C | KINEX | EPALRESTAT | 1 | Oral | 150 MG | 0 | 150 | MG | QD | |||||||
| 115384578 | 11538457 | 6 | C | LOPEMIN | LOPERAMIDE HYDROCHLORIDE | 1 | Oral | 1 MG | 0 | 1 | MG | QD | |||||||
| 115384578 | 11538457 | 7 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Oral | 40 MG | 0 | 40 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115384578 | 11538457 | 1 | Type 2 diabetes mellitus |
| 115384578 | 11538457 | 2 | Type 2 diabetes mellitus |
| 115384578 | 11538457 | 3 | Chronic hepatitis |
| 115384578 | 11538457 | 4 | Product used for unknown indication |
| 115384578 | 11538457 | 5 | Product used for unknown indication |
| 115384578 | 11538457 | 6 | Product used for unknown indication |
| 115384578 | 11538457 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115384578 | 11538457 | DE |
| 115384578 | 11538457 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115384578 | 11538457 | Anaemia | |
| 115384578 | 11538457 | Death | |
| 115384578 | 11538457 | Decreased appetite | |
| 115384578 | 11538457 | Diabetes mellitus inadequate control | |
| 115384578 | 11538457 | Gastric adenoma | |
| 115384578 | 11538457 | Hypercholesterolaemia | |
| 115384578 | 11538457 | Nephrotic syndrome | |
| 115384578 | 11538457 | Spinal compression fracture |
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 |
|---|---|---|---|---|---|---|
| 115384578 | 11538457 | 1 | 20131210 | 20160126 | 0 | |
| 115384578 | 11538457 | 2 | 20150323 | 0 | ||
| 115384578 | 11538457 | 3 | 20151029 | 20160106 | 0 | |
| 115384578 | 11538457 | 4 | 20151029 | 20160106 | 0 | |
| 115384578 | 11538457 | 5 | 20140930 | 0 | ||
| 115384578 | 11538457 | 6 | 20160126 | 0 | ||
| 115384578 | 11538457 | 7 | 20141001 | 20160126 | 0 |