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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125582011 | 12558201 | 1 | I | 20160616 | 20160704 | 20160714 | 20160714 | EXP | DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-43935DE | BOEHRINGER INGELHEIM | 19.00 | YR | M | Y | 84.00000 | KG | 20160714 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125582011 | 12558201 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 220 MG | Y | 22512 | 110 | MG | CAPSULE, HARD | BID | |||||
| 125582011 | 12558201 | 2 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Y | 22512 | |||||||||||
| 125582011 | 12558201 | 3 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Y | 22512 | |||||||||||
| 125582011 | 12558201 | 4 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Y | 22512 | |||||||||||
| 125582011 | 12558201 | 5 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Y | 22512 | |||||||||||
| 125582011 | 12558201 | 6 | C | SPIRONOLACTON | SPIRONOLACTONE | 1 | Oral | 100 NR | 0 | TABLET | QD | ||||||||
| 125582011 | 12558201 | 7 | C | TORASEMID | TORSEMIDE | 1 | Oral | 20 NR | 0 | TABLET | BID | ||||||||
| 125582011 | 12558201 | 8 | C | PROPANOLOL | PROPRANOLOL HYDROCHLORIDE | 1 | Oral | 30 NR | 0 | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125582011 | 12558201 | 1 | Splenic thrombosis |
| 125582011 | 12558201 | 2 | Portal vein thrombosis |
| 125582011 | 12558201 | 3 | Thrombosis prophylaxis |
| 125582011 | 12558201 | 4 | Thrombosis prophylaxis |
| 125582011 | 12558201 | 5 | Thrombosis prophylaxis |
| 125582011 | 12558201 | 6 | Ascites |
| 125582011 | 12558201 | 7 | Ascites |
| 125582011 | 12558201 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125582011 | 12558201 | HO |
| 125582011 | 12558201 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125582011 | 12558201 | Anaemia | |
| 125582011 | 12558201 | Diabetic coma | |
| 125582011 | 12558201 | Haematemesis | |
| 125582011 | 12558201 | Haemoglobin decreased | |
| 125582011 | 12558201 | Oesophageal varices haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 125582011 | 12558201 | 1 | 201601 | 20160616 | 0 | |
| 125582011 | 12558201 | 6 | 201601 | 0 | ||
| 125582011 | 12558201 | 7 | 201601 | 0 |