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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125381173 | 12538117 | 3 | F | 20160627 | 20160803 | 20160707 | 20160812 | EXP | FR-BAXALTA-2016BLT004753 | BAXALTA | 49.97 | YR | M | Y | 0.00000 | 20160812 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125381173 | 12538117 | 1 | PS | ADVATE | ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT | 1 | Intravenous (not otherwise specified) | ONE INJECTION, 1X A DAY | N | 125063 | POWDER FOR SOLUTION FOR INJECTION | QD | |||||||
| 125381173 | 12538117 | 2 | SS | ADVATE | ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT | 1 | Intravenous (not otherwise specified) | EVERY DAY X15 DAYS, THEN 2X A WEEK FOR 15 DAYS | N | TAN14126CBA | 125063 | POWDER FOR SOLUTION FOR INJECTION | |||||||
| 125381173 | 12538117 | 3 | SS | ADVATE | ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT | 1 | Unknown | ONE DOSE | N | 125063 | POWDER FOR SOLUTION FOR INJECTION | ||||||||
| 125381173 | 12538117 | 4 | SS | FEIBA | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | Unknown | 6000 U, 3X A WEEK, INFUSION | UNKNOWN | 0 | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | TIW | |||||||
| 125381173 | 12538117 | 5 | SS | FEIBA | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | 0 | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | |||||||||||
| 125381173 | 12538117 | 6 | C | LOXEN /00639802/ | NICARDIPINE | 1 | Oral | 20 MG, 1 TABLET, 3X A DAY | 0 | 20 | MG | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125381173 | 12538117 | 1 | Haemorrhage prophylaxis |
| 125381173 | 12538117 | 2 | Vascular pseudoaneurysm |
| 125381173 | 12538117 | 3 | Haematoma |
| 125381173 | 12538117 | 4 | Haemophilia A with anti factor VIII |
| 125381173 | 12538117 | 5 | Haemorrhage prophylaxis |
| 125381173 | 12538117 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125381173 | 12538117 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125381173 | 12538117 | Anti factor VIII antibody increased | |
| 125381173 | 12538117 | Factor VIII inhibition | |
| 125381173 | 12538117 | Hepatocellular injury |
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 |
|---|---|---|---|---|---|---|
| 125381173 | 12538117 | 1 | 20160519 | 20160521 | 0 | |
| 125381173 | 12538117 | 2 | 20160530 | 20160624 | 0 | |
| 125381173 | 12538117 | 3 | 2014 | 0 | ||
| 125381173 | 12538117 | 4 | 20160630 | 0 |