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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125236931 | 12523693 | 1 | I | 20160617 | 20160704 | 20160704 | EXP | US-CIPLA-2016US07746 | CIPLA | ADAMS CB, VOLLMAN KE, LEVENTHAL EL, ACQUISTO NM. EMERGENT PEDIATRIC ANTICOAGULATION REVERSAL USING A 4-FACTOR PROTHROMBIN COMPLEX CONCENTRATE. AMERICAN JOURNAL OF EMERGENCY MEDICINE. 2016;34(6):1182.E1 TO 1182.E2 | 0.00 | Y | 0.00000 | 20160704 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125236931 | 12523693 | 1 | PS | Warfarin | WARFARIN | 1 | Unknown | 7.5 MG, QD | 90935 | 7.5 | MG | ||||||||
| 125236931 | 12523693 | 2 | SS | Warfarin | WARFARIN | 1 | Unknown | 10 MG, QD | 90935 | 10 | MG | ||||||||
| 125236931 | 12523693 | 3 | SS | Enoxaparin | ENOXAPARIN | 1 | Subcutaneous | 60 MG, BID | 0 | 60 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125236931 | 12523693 | 1 | Deep vein thrombosis |
| 125236931 | 12523693 | 3 | Anticoagulation drug level below therapeutic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125236931 | 12523693 | HO |
| 125236931 | 12523693 | DE |
| 125236931 | 12523693 | LT |
| 125236931 | 12523693 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125236931 | 12523693 | Coagulopathy | |
| 125236931 | 12523693 | Death | |
| 125236931 | 12523693 | Headache | |
| 125236931 | 12523693 | Hydrocephalus | |
| 125236931 | 12523693 | Hypotension | |
| 125236931 | 12523693 | International normalised ratio fluctuation | |
| 125236931 | 12523693 | Respiration abnormal | |
| 125236931 | 12523693 | Somnolence | |
| 125236931 | 12523693 | Tachycardia | |
| 125236931 | 12523693 | Tumour haemorrhage |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |