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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124407483 | 12440748 | 3 | F | 20160513 | 20160908 | 20160606 | 20160915 | EXP | JP-BAXALTA-2016BXJ003669 | BAXALTA | 62.03 | YR | M | Y | 60.50000 | KG | 20160915 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124407483 | 12440748 | 1 | PS | FEIBA | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | Intravenous (not otherwise specified) | 4000 IU, 1X A DAY | 14000 | IU | U | 140 | 4000 | IU | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | QD | |||
| 124407483 | 12440748 | 2 | SS | FEIBA | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | Intravenous (not otherwise specified) | 2000 IU, 1X A DAY | 14000 | IU | U | 140 | 2000 | IU | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | QD | |||
| 124407483 | 12440748 | 3 | SS | FEIBA | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | Intravenous (not otherwise specified) | 4000 IU, 1X A DAY | 14000 | IU | U | 140 | 4000 | IU | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | QD | |||
| 124407483 | 12440748 | 4 | SS | FEIBA | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | Intravenous (not otherwise specified) | 4000 IU, 1X A DAY | 14000 | IU | U | 140 | 4000 | IU | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | QD | |||
| 124407483 | 12440748 | 5 | SS | FEIBA | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | Intravenous (not otherwise specified) | 4000 IU, 1X A DAY | 14000 | IU | U | 140 | 4000 | IU | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | QD | |||
| 124407483 | 12440748 | 6 | SS | FEIBA | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | Intravenous (not otherwise specified) | 3000 IU, 1X A DAY | 14000 | IU | U | 140 | 3000 | IU | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | QD | |||
| 124407483 | 12440748 | 7 | SS | FEIBA | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | Intravenous (not otherwise specified) | 3000 IU, 1X A DAY | 14000 | IU | U | 140 | 3000 | IU | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | QD | |||
| 124407483 | 12440748 | 8 | SS | FEIBA | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | Intravenous (not otherwise specified) | 2000 IU, 1X A DAY | 14000 | IU | U | 140 | 2000 | IU | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | QD | |||
| 124407483 | 12440748 | 9 | SS | FEIBA | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | Intravenous (not otherwise specified) | 2000 IU, 1X A DAY | 14000 | IU | U | 140 | 2000 | IU | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | QD | |||
| 124407483 | 12440748 | 10 | SS | FEIBA | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | Intravenous (not otherwise specified) | 2000 IU, 1X A DAY | 14000 | IU | U | 140 | 2000 | IU | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | QD | |||
| 124407483 | 12440748 | 11 | SS | FEIBA | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | Intravenous (not otherwise specified) | 2000 IU, 1X A DAY | 14000 | IU | U | 140 | 2000 | IU | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | QD | |||
| 124407483 | 12440748 | 12 | SS | FEIBA | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | Intravenous (not otherwise specified) | 2000 IU, 1X A DAY | 14000 | IU | U | 140 | 2000 | IU | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | QD | |||
| 124407483 | 12440748 | 13 | SS | NOVOSEVEN | COAGULATION FACTOR VIIA RECOMBINANT HUMAN | 1 | Intravenous (not otherwise specified) | 5 MG, 1X A DAY | 63 | MG | Y | N | 0 | 5 | MG | QD | |||
| 124407483 | 12440748 | 14 | SS | NOVOSEVEN | COAGULATION FACTOR VIIA RECOMBINANT HUMAN | 1 | Intravenous (not otherwise specified) | 2 MG, 1X A DAY | 63 | MG | Y | N | 0 | 2 | MG | QD | |||
| 124407483 | 12440748 | 15 | SS | NOVOSEVEN | COAGULATION FACTOR VIIA RECOMBINANT HUMAN | 1 | Intravenous (not otherwise specified) | 2 MG, UNK | 63 | MG | Y | N | 0 | 2 | MG | ||||
| 124407483 | 12440748 | 16 | SS | NOVOSEVEN | COAGULATION FACTOR VIIA RECOMBINANT HUMAN | 1 | Intravenous (not otherwise specified) | 5 MG, UNK | 63 | MG | Y | N | 0 | 5 | MG | ||||
| 124407483 | 12440748 | 17 | SS | BYCLOT | COAGULATION FACTOR VII HUMANCOAGULATION FACTOR X HUMAN | 1 | Intravenous (not otherwise specified) | 5 UNK, 1X A DAY | 25 | DF | Y | N | 0 | 5 | DF | QD | |||
| 124407483 | 12440748 | 18 | C | SOSEGON /00052101/ | PENTAZOCINE | 1 | Intravenous (not otherwise specified) | 15 MG, UNK | U | 0 | 15 | MG | |||||||
| 124407483 | 12440748 | 19 | C | SOSEGON /00052101/ | PENTAZOCINE | 1 | U | 0 | |||||||||||
| 124407483 | 12440748 | 20 | C | SERENACE | HALOPERIDOL | 1 | Intravenous (not otherwise specified) | 2 MG, 1X A DAY | 2 | MG | U | 0 | 2 | MG | QD | ||||
| 124407483 | 12440748 | 21 | C | SERENACE | HALOPERIDOL | 1 | Intravenous (not otherwise specified) | 5 MG, UNK | 2 | MG | U | 0 | 5 | MG | |||||
| 124407483 | 12440748 | 22 | C | FLUMAZENIL. | FLUMAZENIL | 1 | Intravenous (not otherwise specified) | 0.5 MG, UNK | U | 0 | .5 | MG | |||||||
| 124407483 | 12440748 | 23 | C | FENTANYL. | FENTANYL | 1 | Intravenous (not otherwise specified) | 0.4 MG, UNK | U | 0 | .4 | MG | |||||||
| 124407483 | 12440748 | 24 | C | MIDAZOLAM | MIDAZOLAMMIDAZOLAM HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 5 MG, UNK | U | 0 | 5 | MG | |||||||
| 124407483 | 12440748 | 25 | C | MIDAZOLAM | MIDAZOLAMMIDAZOLAM HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 10 MG, UNK | U | 0 | 10 | MG | |||||||
| 124407483 | 12440748 | 26 | C | MIDAZOLAM | MIDAZOLAMMIDAZOLAM HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 40 MG, UNK | U | 0 | 40 | MG | |||||||
| 124407483 | 12440748 | 27 | C | MIDAZOLAM | MIDAZOLAMMIDAZOLAM HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 20 MG, UNK | U | 0 | 20 | MG | |||||||
| 124407483 | 12440748 | 28 | C | MIDAZOLAM | MIDAZOLAMMIDAZOLAM HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 10 MG, UNK | U | 0 | 10 | MG | |||||||
| 124407483 | 12440748 | 29 | C | PROPOFOL. | PROPOFOL | 1 | Intravenous (not otherwise specified) | UNK | U | 0 | |||||||||
| 124407483 | 12440748 | 30 | C | PROPOFOL. | PROPOFOL | 1 | Intravenous (not otherwise specified) | 500 MG, UNK | U | 0 | 500 | MG | |||||||
| 124407483 | 12440748 | 31 | C | PROPOFOL. | PROPOFOL | 1 | Intravenous (not otherwise specified) | 1500 MG, UNK | U | 0 | 1500 | MG | |||||||
| 124407483 | 12440748 | 32 | C | PROPOFOL. | PROPOFOL | 1 | Intravenous (not otherwise specified) | 500 MG, UNK | U | 0 | 500 | MG | |||||||
| 124407483 | 12440748 | 33 | C | RECOMBINATE | ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT | 1 | Intravenous (not otherwise specified) | UNK | U | 0 | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | ||||||||
| 124407483 | 12440748 | 34 | C | ADVATE | ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT | 1 | Intravenous (not otherwise specified) | UNK | U | 0 | POWDER FOR SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124407483 | 12440748 | 1 | Haemophilia A with anti factor VIII |
| 124407483 | 12440748 | 13 | Haemorrhage |
| 124407483 | 12440748 | 17 | Haemorrhage |
| 124407483 | 12440748 | 18 | Sedation |
| 124407483 | 12440748 | 19 | Analgesic therapy |
| 124407483 | 12440748 | 20 | Restlessness |
| 124407483 | 12440748 | 22 | Anaesthesia reversal |
| 124407483 | 12440748 | 23 | Sedation |
| 124407483 | 12440748 | 24 | Sedation |
| 124407483 | 12440748 | 25 | Analgesic therapy |
| 124407483 | 12440748 | 29 | Sedation |
| 124407483 | 12440748 | 33 | Factor VIII deficiency |
| 124407483 | 12440748 | 34 | Factor VIII deficiency |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124407483 | 12440748 | DS |
| 124407483 | 12440748 | LT |
| 124407483 | 12440748 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124407483 | 12440748 | Cerebral infarction | |
| 124407483 | 12440748 | Lower gastrointestinal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 124407483 | 12440748 | 1 | 20160509 | 20160509 | 0 | |
| 124407483 | 12440748 | 2 | 20160511 | 20160511 | 0 | |
| 124407483 | 12440748 | 3 | 20160516 | 20160609 | 0 | |
| 124407483 | 12440748 | 4 | 20160613 | 20160618 | 0 | |
| 124407483 | 12440748 | 5 | 20160620 | 20160620 | 0 | |
| 124407483 | 12440748 | 6 | 20160622 | 20160622 | 0 | |
| 124407483 | 12440748 | 7 | 20160624 | 20160624 | 0 | |
| 124407483 | 12440748 | 8 | 20160627 | 20160627 | 0 | |
| 124407483 | 12440748 | 9 | 20160629 | 20160629 | 0 | |
| 124407483 | 12440748 | 10 | 20160701 | 20160701 | 0 | |
| 124407483 | 12440748 | 11 | 20160704 | 20160704 | 0 | |
| 124407483 | 12440748 | 12 | 20160706 | 20160706 | 0 | |
| 124407483 | 12440748 | 13 | 20160509 | 20160522 | 0 | |
| 124407483 | 12440748 | 14 | 20160509 | 20160522 | 0 | |
| 124407483 | 12440748 | 15 | 20160513 | 20160516 | 0 | |
| 124407483 | 12440748 | 16 | 20160525 | 20160608 | 0 | |
| 124407483 | 12440748 | 17 | 20160513 | 20160526 | 0 | |
| 124407483 | 12440748 | 18 | 20160515 | 20160516 | 0 | |
| 124407483 | 12440748 | 20 | 20160515 | 20160515 | 0 | |
| 124407483 | 12440748 | 21 | 20160516 | 20160516 | 0 | |
| 124407483 | 12440748 | 22 | 20160515 | 20160516 | 0 | |
| 124407483 | 12440748 | 23 | 20160516 | 20160531 | 0 | |
| 124407483 | 12440748 | 24 | 20160515 | 20160515 | 0 | |
| 124407483 | 12440748 | 25 | 20160516 | 20160516 | 0 | |
| 124407483 | 12440748 | 26 | 20160518 | 20160518 | 0 | |
| 124407483 | 12440748 | 27 | 20160518 | 20160523 | 0 | |
| 124407483 | 12440748 | 28 | 20160525 | 20160525 | 0 | |
| 124407483 | 12440748 | 29 | 20160516 | 20160516 | 0 | |
| 124407483 | 12440748 | 30 | 20160525 | 20160526 | 0 | |
| 124407483 | 12440748 | 31 | 20160526 | 20160526 | 0 | |
| 124407483 | 12440748 | 32 | 20160526 | 20160531 | 0 | |
| 124407483 | 12440748 | 33 | 200602 | 200603 | 0 | |
| 124407483 | 12440748 | 34 | 20070906 | 20080122 | 0 |