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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120500233 | 12050023 | 3 | F | 201508 | 20160808 | 20160208 | 20160811 | EXP | BR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-06700BR | BOEHRINGER INGELHEIM | 90.00 | YR | F | Y | 70.00000 | KG | 20160811 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120500233 | 12050023 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 75 MG | Y | 22512 | 75 | MG | CAPSULE | QD | |||||
| 120500233 | 12050023 | 2 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 150 MG | Y | 22512 | 75 | MG | CAPSULE | BID | |||||
| 120500233 | 12050023 | 3 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 110 MG | Y | 22512 | 110 | MG | CAPSULE | QD | |||||
| 120500233 | 12050023 | 4 | C | CONCOR | BISOPROLOL FUMARATE | 1 | Oral | 5 MG | 0 | 5 | MG | TABLET | QD | ||||||
| 120500233 | 12050023 | 5 | C | SUSTRATE | PROPATYL NITRATE | 1 | Oral | 5 MG | 0 | 2.5 | MG | TABLET | BID | ||||||
| 120500233 | 12050023 | 6 | C | VASOGARD | CILOSTAZOL | 1 | Oral | 50 MG | 0 | 50 | MG | TABLET | QD | ||||||
| 120500233 | 12050023 | 7 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Oral | 60 MG | 0 | 60 | MG | TABLET | QD | ||||||
| 120500233 | 12050023 | 8 | C | LANTUS | INSULIN GLARGINE | 1 | Subcutaneous | 20 MG | 0 | 20 | MG | QD | |||||||
| 120500233 | 12050023 | 9 | C | HUMALOG | INSULIN LISPRO | 1 | Subcutaneous | FORMULATION: INJECTABLE | 0 | ||||||||||
| 120500233 | 12050023 | 10 | C | MICARDIS | TELMISARTAN | 1 | Unknown | 80 MG | 0 | 80 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120500233 | 12050023 | 1 | Cerebrovascular accident prophylaxis |
| 120500233 | 12050023 | 4 | Product used for unknown indication |
| 120500233 | 12050023 | 5 | Cardiovascular disorder |
| 120500233 | 12050023 | 6 | Angiopathy |
| 120500233 | 12050023 | 7 | Blood cholesterol increased |
| 120500233 | 12050023 | 8 | Type 2 diabetes mellitus |
| 120500233 | 12050023 | 9 | Type 2 diabetes mellitus |
| 120500233 | 12050023 | 10 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120500233 | 12050023 | DS |
| 120500233 | 12050023 | HO |
| 120500233 | 12050023 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120500233 | 12050023 | Aphasia | |
| 120500233 | 12050023 | Blister | |
| 120500233 | 12050023 | Haematochezia | |
| 120500233 | 12050023 | Infection | |
| 120500233 | 12050023 | Ischaemic stroke | |
| 120500233 | 12050023 | Movement disorder | |
| 120500233 | 12050023 | Respiratory tract infection | |
| 120500233 | 12050023 | Skin sensitisation |
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 |
|---|---|---|---|---|---|---|
| 120500233 | 12050023 | 1 | 2012 | 0 | ||
| 120500233 | 12050023 | 2 | 201601 | 0 | ||
| 120500233 | 12050023 | 3 | 20160111 | 20160708 | 0 | |
| 120500233 | 12050023 | 4 | 2012 | 0 | ||
| 120500233 | 12050023 | 5 | 2012 | 0 | ||
| 120500233 | 12050023 | 6 | 2012 | 0 | ||
| 120500233 | 12050023 | 7 | 2012 | 0 | ||
| 120500233 | 12050023 | 8 | 2011 | 0 | ||
| 120500233 | 12050023 | 9 | 2011 | 0 | ||
| 120500233 | 12050023 | 10 | 2012 | 0 |