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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126109343 | 12610934 | 3 | F | 2016 | 20160803 | 20160801 | 20160811 | EXP | BR-SA-2016SA133282 | AVENTIS | 46.00 | YR | A | F | Y | 98.00000 | KG | 20160811 | MD | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126109343 | 12610934 | 1 | SS | CLIKSTAR | CLIKSTAR | 1 | START: 2-3 MONTHS AGO | L564 | 0 | ||||||||||
| 126109343 | 12610934 | 2 | PS | LANTUS | INSULIN GLARGINE | 1 | Subcutaneous | U | UNK | 21081 | SOLUTION FOR INJECTION | ||||||||
| 126109343 | 12610934 | 3 | C | VENLAFAXINE HYDROCHLORIDE. | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 0 | BID | ||||||||||
| 126109343 | 12610934 | 4 | C | FLUOXETINE HYDROCHLORIDE. | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 0 | 1 | DF | TABLET | TID | |||||||
| 126109343 | 12610934 | 5 | C | RIVOTRIL | CLONAZEPAM | 1 | Oral | 0 | 1 | DF | TABLET | QD | |||||||
| 126109343 | 12610934 | 6 | C | RIVOTRIL | CLONAZEPAM | 1 | Oral | 0 | 1 | DF | TABLET | QD | |||||||
| 126109343 | 12610934 | 7 | C | DIGESAN | BROMOPRIDE | 1 | Oral | 0 | 1 | DF | TABLET | Q8H | |||||||
| 126109343 | 12610934 | 8 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 | 1 | DF | TABLET | BID | |||||||
| 126109343 | 12610934 | 9 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 0 | 1 | DF | TABLET | QD | |||||||
| 126109343 | 12610934 | 10 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 0 | 1 | DF | TABLET | QD | |||||||
| 126109343 | 12610934 | 11 | C | AAS | ASPIRIN | 1 | Oral | 0 | 1 | DF | TABLET | QD | |||||||
| 126109343 | 12610934 | 12 | C | LOSARTAN POTASSIUM. | LOSARTAN POTASSIUM | 1 | Oral | 0 | 1 | DF | TABLET | BID | |||||||
| 126109343 | 12610934 | 13 | C | CHLORTALIDONE | CHLORTHALIDONE | 1 | Oral | 0 | 1 | DF | TABLET | QD | |||||||
| 126109343 | 12610934 | 14 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | Oral | DOSE:1 TABLET BEFORE THE BREAKFAST, 2 TABLETS BEFORE THE LUNCH AND 1 TABLET BEFORE THE DINNER | 0 | TABLET | |||||||||
| 126109343 | 12610934 | 15 | C | PURAN | LEVOTHYROXINE SODIUM | 1 | Oral | 0 | 1 | DF | TABLET | QD | |||||||
| 126109343 | 12610934 | 16 | C | BUDESONIDE. | BUDESONIDE | 1 | Oral | 0 | 1 | DF | TABLET | Q8H | |||||||
| 126109343 | 12610934 | 17 | C | URSACOL | URSODIOL | 1 | Oral | DOSE:3 TABLETS BEFORE THE LUNCH, AND 2 TABLETS BEFORE THE DINNER | 0 | TABLET | BID | ||||||||
| 126109343 | 12610934 | 18 | C | METFORMIN HYDROCHLORIDE. | METFORMIN HYDROCHLORIDE | 1 | Oral | 0 | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126109343 | 12610934 | 1 | Type 2 diabetes mellitus |
| 126109343 | 12610934 | 2 | Type 2 diabetes mellitus |
| 126109343 | 12610934 | 3 | Muscle relaxant therapy |
| 126109343 | 12610934 | 4 | Anxiety |
| 126109343 | 12610934 | 5 | Sleep disorder |
| 126109343 | 12610934 | 6 | Anxiety |
| 126109343 | 12610934 | 7 | Gastric disorder |
| 126109343 | 12610934 | 8 | Gastric disorder |
| 126109343 | 12610934 | 9 | Prophylaxis |
| 126109343 | 12610934 | 10 | Blood pressure measurement |
| 126109343 | 12610934 | 11 | Coagulopathy |
| 126109343 | 12610934 | 12 | Blood pressure measurement |
| 126109343 | 12610934 | 13 | Blood pressure measurement |
| 126109343 | 12610934 | 14 | Pernicious anaemia |
| 126109343 | 12610934 | 15 | Hypothyroidism |
| 126109343 | 12610934 | 16 | Liver disorder |
| 126109343 | 12610934 | 17 | Liver disorder |
| 126109343 | 12610934 | 18 | Diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126109343 | 12610934 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126109343 | 12610934 | Biliary cirrhosis | |
| 126109343 | 12610934 | Blood glucose increased | |
| 126109343 | 12610934 | Device use issue | |
| 126109343 | 12610934 | Diabetes mellitus |
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 |
|---|---|---|---|---|---|---|
| 126109343 | 12610934 | 1 | 2016 | 0 | ||
| 126109343 | 12610934 | 2 | 2016 | 0 | ||
| 126109343 | 12610934 | 3 | 2015 | 0 | ||
| 126109343 | 12610934 | 4 | 2014 | 0 | ||
| 126109343 | 12610934 | 5 | 2014 | 0 | ||
| 126109343 | 12610934 | 6 | 2014 | 0 | ||
| 126109343 | 12610934 | 7 | 2014 | 0 | ||
| 126109343 | 12610934 | 8 | 2014 | 0 | ||
| 126109343 | 12610934 | 9 | 2013 | 0 | ||
| 126109343 | 12610934 | 10 | 2014 | 0 | ||
| 126109343 | 12610934 | 11 | 2013 | 0 | ||
| 126109343 | 12610934 | 12 | 2014 | 0 | ||
| 126109343 | 12610934 | 13 | 2014 | 0 | ||
| 126109343 | 12610934 | 14 | 2014 | 0 | ||
| 126109343 | 12610934 | 15 | 2015 | 0 | ||
| 126109343 | 12610934 | 16 | 2015 | 0 | ||
| 126109343 | 12610934 | 17 | 2015 | 0 | ||
| 126109343 | 12610934 | 18 | 2006 | 0 |