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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125659132 | 12565913 | 2 | F | 20160714 | 20160718 | 20160722 | EXP | DE-BAXALTA-2016BLT002807 | BAXALTA | 76.00 | YR | M | Y | 0.00000 | 20160722 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125659132 | 12565913 | 1 | PS | OBIZUR | ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT | 1 | 50 IU/KG, UNK | 125512 | 50 | IU/KG | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | ||||||||
| 125659132 | 12565913 | 2 | SS | OBIZUR | ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT | 1 | Unknown | 100 IU/KG, 1X A DAY | 125512 | 100 | IU/KG | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | QD | ||||||
| 125659132 | 12565913 | 3 | SS | OBIZUR | ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT | 1 | Unknown | TWO TIMES IN WEEK 6 | 125512 | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | |||||||||
| 125659132 | 12565913 | 4 | SS | OBIZUR | ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT | 1 | Unknown | UNK, IN WEEK 6 | 125512 | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | |||||||||
| 125659132 | 12565913 | 5 | SS | NOVOSEVEN | COAGULATION FACTOR VIIA RECOMBINANT HUMAN | 1 | Unknown | UNK | 0 | ||||||||||
| 125659132 | 12565913 | 6 | C | PREDNISOLONE. | PREDNISOLONE | 1 | U | 0 | |||||||||||
| 125659132 | 12565913 | 7 | C | PREDNISOLONE. | PREDNISOLONE | 1 | U | 0 | |||||||||||
| 125659132 | 12565913 | 8 | C | RITUXIMAB | RITUXIMAB | 1 | U | 0 | |||||||||||
| 125659132 | 12565913 | 9 | C | RITUXIMAB | RITUXIMAB | 1 | U | 0 | |||||||||||
| 125659132 | 12565913 | 10 | C | FACTOR VIIA, RECOMBINANT | COAGULATION FACTOR VIIA RECOMBINANT HUMAN | 1 | UNK | U | 0 | ||||||||||
| 125659132 | 12565913 | 11 | C | RED BLOOD CELLS | HUMAN RED BLOOD CELL | 1 | U | 0 | |||||||||||
| 125659132 | 12565913 | 12 | C | FACTOR VIII | ANTIHEMOPHILIC FACTOR HUMAN | 1 | U | 0 | |||||||||||
| 125659132 | 12565913 | 13 | C | PLATELETS | HUMAN PLATELET, ALLOGENIC | 1 | U | 0 | |||||||||||
| 125659132 | 12565913 | 14 | C | HUMAN FACTOR VIII | 2 | IN WEEK 6 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125659132 | 12565913 | 1 | Haemorrhage |
| 125659132 | 12565913 | 5 | Product used for unknown indication |
| 125659132 | 12565913 | 6 | Immunosuppression |
| 125659132 | 12565913 | 7 | Inhibiting antibodies |
| 125659132 | 12565913 | 8 | Immunosuppression |
| 125659132 | 12565913 | 9 | Inhibiting antibodies |
| 125659132 | 12565913 | 10 | Product used for unknown indication |
| 125659132 | 12565913 | 11 | Haemorrhagic diathesis |
| 125659132 | 12565913 | 12 | Haemorrhagic diathesis |
| 125659132 | 12565913 | 13 | Haemorrhagic diathesis |
| 125659132 | 12565913 | 14 | Haemothorax |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125659132 | 12565913 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125659132 | 12565913 | Cardiogenic shock | |
| 125659132 | 12565913 | Condition aggravated | |
| 125659132 | 12565913 | Drug effect decreased | |
| 125659132 | 12565913 | Haemorrhage | |
| 125659132 | 12565913 | Haemothorax | |
| 125659132 | 12565913 | Intensive care unit acquired weakness | |
| 125659132 | 12565913 | Neutropenia | |
| 125659132 | 12565913 | Pneumonia | |
| 125659132 | 12565913 | Renal failure |
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 |
|---|---|---|---|---|---|---|
| 125659132 | 12565913 | 1 | 20160406 | 0 | ||
| 125659132 | 12565913 | 2 | 20160426 | 0 |