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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124254794 | 12425479 | 4 | F | 20160513 | 20160719 | 20160601 | 20160721 | EXP | PT-INFARMED-L201605-119 | PT-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-34839PO | BOEHRINGER INGELHEIM | 86.42 | YR | F | Y | 0.00000 | 20160721 | MD | PT | PT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124254794 | 12425479 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 220 MG | Y | 22512 | 110 | MG | Q12H | ||||||
| 124254794 | 12425479 | 2 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 150 MG | Y | 22512 | 75 | MG | Q12H | ||||||
| 124254794 | 12425479 | 3 | SS | PANTOC | PANTOPRAZOLE SODIUM | 1 | Oral | 20 MG | U | 0 | 20 | MG | QD | ||||||
| 124254794 | 12425479 | 4 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | 5 MG | 0 | 5 | MG | QD | |||||||
| 124254794 | 12425479 | 5 | C | RIVOTRIL | CLONAZEPAM | 1 | Oral | 0.5 MG | 0 | .5 | MG | QD | |||||||
| 124254794 | 12425479 | 6 | C | JANUVIA | SITAGLIPTIN PHOSPHATE | 1 | Oral | 1 ANZ | 0 | QD | |||||||||
| 124254794 | 12425479 | 7 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 1 ANZ | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124254794 | 12425479 | 1 | Atrial fibrillation |
| 124254794 | 12425479 | 3 | Product used for unknown indication |
| 124254794 | 12425479 | 4 | Hypertension |
| 124254794 | 12425479 | 5 | Product used for unknown indication |
| 124254794 | 12425479 | 6 | Type 2 diabetes mellitus |
| 124254794 | 12425479 | 7 | Type 2 diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124254794 | 12425479 | LT |
| 124254794 | 12425479 | OT |
| 124254794 | 12425479 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124254794 | 12425479 | Activated partial thromboplastin time prolonged | |
| 124254794 | 12425479 | C-reactive protein increased | |
| 124254794 | 12425479 | Haematochezia | |
| 124254794 | 12425479 | Inflammatory marker increased | |
| 124254794 | 12425479 | Leukocytosis | |
| 124254794 | 12425479 | Rectal haemorrhage | |
| 124254794 | 12425479 | Renal impairment | |
| 124254794 | 12425479 | Thrombocytopenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |