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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127156031 | 12715603 | 1 | I | 20160823 | 20160906 | 20160906 | EXP | US-ZYDUS-011996 | ZYDUS PHARM | KARLI B, BARTEL B, PAVELKO R. REVERSAL STRATEGIES FOR INTRACRANIAL HEMORRHAGES IN PATIENTS TAKING ORAL FACTOR XA INHIBITORS. HOSP-PHARM 2015; 50 (7):569-577. | 78.00 | YR | E | M | Y | 88.40000 | KG | 20160906 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127156031 | 12715603 | 1 | PS | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | U | UNKNOWN | 78226 | |||||||||
| 127156031 | 12715603 | 2 | SS | PRAVASTATIN. | PRAVASTATIN | 1 | Unknown | U | UNKNOWN | 77751 | |||||||||
| 127156031 | 12715603 | 3 | SS | GLIPIZIDE/METFORMIN | GLIPIZIDEMETFORMIN HYDROCHLORIDE | 1 | Unknown | U | UNKNOWN | 78905 | |||||||||
| 127156031 | 12715603 | 4 | SS | APIXABAN | APIXABAN | 1 | Unknown | U | UNKNOWN | 0 | 5 | MG | BID | ||||||
| 127156031 | 12715603 | 5 | SS | DUTASTERIDE + TAMSULOSIN | DUTASTERIDETAMSULOSIN HYDROCHLORIDE | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 127156031 | 12715603 | 6 | SS | DEXLANSOPRAZOLE | DEXLANSOPRAZOLE | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 127156031 | 12715603 | 7 | SS | LISINOPRIL. | LISINOPRIL | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 127156031 | 12715603 | 8 | SS | LORATADINE. | LORATADINE | 1 | Unknown | U | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127156031 | 12715603 | 1 | Product used for unknown indication |
| 127156031 | 12715603 | 2 | Product used for unknown indication |
| 127156031 | 12715603 | 3 | Product used for unknown indication |
| 127156031 | 12715603 | 4 | Product used for unknown indication |
| 127156031 | 12715603 | 5 | Product used for unknown indication |
| 127156031 | 12715603 | 6 | Product used for unknown indication |
| 127156031 | 12715603 | 7 | Product used for unknown indication |
| 127156031 | 12715603 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127156031 | 12715603 | OT |
| 127156031 | 12715603 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127156031 | 12715603 | Aphasia | |
| 127156031 | 12715603 | Confusional state | |
| 127156031 | 12715603 | Disorientation | |
| 127156031 | 12715603 | Dysarthria | |
| 127156031 | 12715603 | Dysphagia | |
| 127156031 | 12715603 | Encephalopathy | |
| 127156031 | 12715603 | Facial paralysis | |
| 127156031 | 12715603 | Haemorrhage intracranial | |
| 127156031 | 12715603 | Headache | |
| 127156031 | 12715603 | Lethargy | |
| 127156031 | 12715603 | Prothrombin time prolonged | |
| 127156031 | 12715603 | Subdural haematoma |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |