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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125224031 | 12522403 | 1 | I | 20160620 | 20160701 | 20160701 | EXP | FR-MYLANLABS-2016M1026842 | MYLAN | D^OLLONE E, ROUAULT A, SONIA P-L, BONNEFOY R, SACHS P, HURTAUD M-F, ET AL. HUMAN PROTHROMBIN COMPLEX IN PAEDIATRICS: HOW TO USE IT?. INT-J-CLIN-PHARM 2016;38(2):534-535 ABSTR. HP-PC060. | 0.00 | Y | 0.00000 | 20160630 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125224031 | 12522403 | 1 | PS | WARFARIN | WARFARIN | 1 | Unknown | 3 MG PER DAY | Y | U | 40415 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125224031 | 12522403 | 1 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125224031 | 12522403 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125224031 | 12522403 | Compartment syndrome | |
| 125224031 | 12522403 | Haematoma | |
| 125224031 | 12522403 | International normalised ratio increased | |
| 125224031 | 12522403 | Overdose | |
| 125224031 | 12522403 | Prothrombin time shortened |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |