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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126002522 | 12600252 | 2 | F | 19830119 | 20160720 | 20160727 | 20160728 | EXP | DE-BAXTER-2007BH002321 | BAXALTA | 17.14 | YR | M | Y | 0.00000 | 20160728 | CN | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126002522 | 12600252 | 1 | SS | FEIBA | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | Unknown | UNK, 2,500 TO 3,000 IU FOR 3 TO 4 DAYS, IF NEEDED | 0 | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | |||||||||
| 126002522 | 12600252 | 2 | SS | FEIBA | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | Unknown | 2000 IU, 1X A DAY, CURRENT DOSE | 0 | 2000 | IU | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | QD | ||||||
| 126002522 | 12600252 | 3 | SS | FEIBA | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | Unknown | 6000 IU, AS NEEDED, 3-4 DAYS ON DEMAND, CURRENT DOSE | 0 | 6000 | IU | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | 1X | ||||||
| 126002522 | 12600252 | 4 | PS | HEMOFIL M | ANTIHEMOPHILIC FACTOR HUMAN | 1 | Unknown | UNK | U | 101448 | POWDER FOR SOLUTION FOR INJECTION | ||||||||
| 126002522 | 12600252 | 5 | SS | HEMOFIL M | ANTIHEMOPHILIC FACTOR HUMAN | 1 | Unknown | UNK | U | 101448 | POWDER FOR SOLUTION FOR INJECTION | ||||||||
| 126002522 | 12600252 | 6 | SS | HEMOFIL M | ANTIHEMOPHILIC FACTOR HUMAN | 1 | Unknown | UNK | U | 101448 | POWDER FOR SOLUTION FOR INJECTION | ||||||||
| 126002522 | 12600252 | 7 | SS | FACTOR VIII (CUTTER) (FACTOR VIII ANTIHEMOPHILIC FACTOR) | ANTIHEMOPHILIC FACTOR HUMAN | 1 | Unknown | UNK | U | 0 | |||||||||
| 126002522 | 12600252 | 8 | SS | FACTOR VIII (ALPHA THERAPEUTIC CORPORATION) | ANTIHEMOPHILIC FACTOR HUMAN | 1 | Unknown | UNK | U | 0 | |||||||||
| 126002522 | 12600252 | 9 | SS | FACTOR VIII (ARMOUR PHARMACEUTICAL COMPANY) | ANTIHEMOPHILIC FACTOR HUMAN | 1 | Unknown | UNK | U | 0 | |||||||||
| 126002522 | 12600252 | 10 | SS | FACTOR VIII (NHS) | ANTIHEMOPHILIC FACTOR HUMAN | 1 | Unknown | UNK | U | 0 | |||||||||
| 126002522 | 12600252 | 11 | SS | FACTOR VIII (NHS) | ANTIHEMOPHILIC FACTOR HUMAN | 1 | Unknown | UNK | U | 0 | |||||||||
| 126002522 | 12600252 | 12 | SS | BLOOD, WHOLE | WHOLE BLOOD | 1 | Unknown | UNK | U | 0 | |||||||||
| 126002522 | 12600252 | 13 | SS | CRYOPRECIPITATE | CRYOPRECIPITATED ANTIHEMOPHILIC FACTOR (HUMAN) | 1 | Unknown | UNK | U | 0 | |||||||||
| 126002522 | 12600252 | 14 | C | TRUVADA | EMTRICITABINETENOFOVIR DISOPROXIL FUMARATE | 1 | 0 | ||||||||||||
| 126002522 | 12600252 | 15 | C | RALTEGRAVIR. | RALTEGRAVIR | 1 | 0 | ||||||||||||
| 126002522 | 12600252 | 16 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126002522 | 12600252 | 1 | Haemophilia A with anti factor VIII |
| 126002522 | 12600252 | 2 | Haemorrhage |
| 126002522 | 12600252 | 4 | Factor VIII deficiency |
| 126002522 | 12600252 | 7 | Factor VIII deficiency |
| 126002522 | 12600252 | 8 | Factor VIII deficiency |
| 126002522 | 12600252 | 9 | Factor VIII deficiency |
| 126002522 | 12600252 | 10 | Factor VIII deficiency |
| 126002522 | 12600252 | 12 | Product used for unknown indication |
| 126002522 | 12600252 | 13 | Product used for unknown indication |
| 126002522 | 12600252 | 14 | Product used for unknown indication |
| 126002522 | 12600252 | 15 | Product used for unknown indication |
| 126002522 | 12600252 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126002522 | 12600252 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126002522 | 12600252 | Depression | |
| 126002522 | 12600252 | Fatigue | |
| 126002522 | 12600252 | HIV infection | |
| 126002522 | 12600252 | Hepatitis A | |
| 126002522 | 12600252 | Hepatitis B | |
| 126002522 | 12600252 | Hepatitis C | |
| 126002522 | 12600252 | Malaise | |
| 126002522 | 12600252 | Product contamination microbial |
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 |
|---|---|---|---|---|---|---|
| 126002522 | 12600252 | 1 | 1984 | 0 | ||
| 126002522 | 12600252 | 4 | 1977 | 0 | ||
| 126002522 | 12600252 | 5 | 1980 | 1984 | 0 | |
| 126002522 | 12600252 | 6 | 1987 | 1989 | 0 | |
| 126002522 | 12600252 | 7 | 1988 | 1989 | 0 | |
| 126002522 | 12600252 | 8 | 1988 | 1989 | 0 | |
| 126002522 | 12600252 | 9 | 1983 | 1985 | 0 | |
| 126002522 | 12600252 | 10 | 1983 | 1985 | 0 | |
| 126002522 | 12600252 | 11 | 1989 | 0 | ||
| 126002522 | 12600252 | 12 | 1984 | 0 |