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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125714031 | 12571403 | 1 | I | 20160704 | 20160719 | 20160719 | EXP | US-IPCA LABORATORIES LIMITED-IPC201607-000594 | IPCA | YANAMADALA V,WALCOTT B,FECCI P,ROZMAN P,KUMAR J,NAHED B. REVERSAL OF WARFARIN ASSOCIATED COAGULOPATHY WITH 4-FACTOR PROTHROMBIN COMPLEX CONCENTRATE IN TRAUMATIC BRAIN INJURY AND INTRACRANIAL HEMORRHAGE. J CLIN NEUROSCI 2014 NOV;21(11):1881-4. | 0.00 | Y | 0.00000 | 20160719 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125714031 | 12571403 | 1 | PS | Warfarin | WARFARIN | 1 | U | U | 200104 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125714031 | 12571403 | 1 | Anticoagulant therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125714031 | 12571403 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125714031 | 12571403 | Haemorrhage intracranial | |
| 125714031 | 12571403 | Hydrocephalus | |
| 125714031 | 12571403 | International normalised ratio increased | |
| 125714031 | 12571403 | Intraventricular haemorrhage |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |