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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125828081 | 12582808 | 1 | I | 20131030 | 20131108 | 20160722 | 20160722 | EXP | US-BAXALTA-2013BAX045037 | BAXALTA | 61.34 | YR | M | Y | 104.00000 | KG | 20160721 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125828081 | 12582808 | 1 | PS | RIXUBIS | COAGULATION FACTOR IX RECOMBINANT HUMAN | 1 | Intravenous (not otherwise specified) | 6122 UNITS +/- 10% DAILY X 4 | Y | TNA13006AC | 125446 | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | QD | ||||||
| 125828081 | 12582808 | 2 | SS | RIXUBIS | COAGULATION FACTOR IX RECOMBINANT HUMAN | 1 | UNK | Y | TNA13007AB | 125446 | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | ||||||||
| 125828081 | 12582808 | 3 | SS | RIXUBIS | COAGULATION FACTOR IX RECOMBINANT HUMAN | 1 | Intravenous (not otherwise specified) | 6122 UNITS +/- 10% DAILY X 4 | Y | TNA13007AB | 125446 | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | QD | ||||||
| 125828081 | 12582808 | 4 | SS | LITHIUM CARBONATE. | LITHIUM CARBONATE | 1 | Oral | 300MILLIGRAM 2X A DAY | Y | 0 | 300 | MG | CAPSULE | BID | |||||
| 125828081 | 12582808 | 5 | C | ATENOLOL. | ATENOLOL | 1 | Oral | 100MILLIGRAM1X A DAY | 0 | 100 | MG | QD | |||||||
| 125828081 | 12582808 | 6 | C | Bupropion HCL | BUPROPION HYDROCHLORIDE | 1 | Oral | 150MILLIGRAM2X A DAY | 0 | 150 | MG | BID | |||||||
| 125828081 | 12582808 | 7 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 100MICROGRAM1X A DAY | 0 | 100 | UG | QD | |||||||
| 125828081 | 12582808 | 8 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | Oral | 1X A DAY | 0 | TABLET | QD | ||||||||
| 125828081 | 12582808 | 9 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 80MILLIGRAM1X A DAY | 0 | 80 | MG | QD | |||||||
| 125828081 | 12582808 | 10 | C | BUSPIRONE | BUSPIRONE HYDROCHLORIDE | 1 | Oral | 10MILLIGRAM2X A DAY | 0 | 10 | MG | TABLET | BID | ||||||
| 125828081 | 12582808 | 11 | C | BUSPIRONE | BUSPIRONE HYDROCHLORIDE | 1 | Oral | 10MILLIGRAM1X A DAY | 0 | 10 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125828081 | 12582808 | 1 | Factor IX deficiency |
| 125828081 | 12582808 | 3 | Factor IX deficiency |
| 125828081 | 12582808 | 4 | Product used for unknown indication |
| 125828081 | 12582808 | 5 | Product used for unknown indication |
| 125828081 | 12582808 | 6 | Product used for unknown indication |
| 125828081 | 12582808 | 7 | Product used for unknown indication |
| 125828081 | 12582808 | 8 | Product used for unknown indication |
| 125828081 | 12582808 | 9 | Product used for unknown indication |
| 125828081 | 12582808 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125828081 | 12582808 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125828081 | 12582808 | Acute kidney injury | |
| 125828081 | 12582808 | Claustrophobia | |
| 125828081 | 12582808 | Cognitive disorder | |
| 125828081 | 12582808 | Dyspnoea | |
| 125828081 | 12582808 | Feeling hot | |
| 125828081 | 12582808 | Gait disturbance | |
| 125828081 | 12582808 | Hypersensitivity | |
| 125828081 | 12582808 | Neurological symptom | |
| 125828081 | 12582808 | Pruritus | |
| 125828081 | 12582808 | Toxicity to various agents | |
| 125828081 | 12582808 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 125828081 | 12582808 | 1 | 20131029 | 20131031 | 0 | |
| 125828081 | 12582808 | 2 | 20131029 | 20131031 | 0 | |
| 125828081 | 12582808 | 3 | 20131029 | 20131031 | 0 | |
| 125828081 | 12582808 | 4 | 20131101 | 0 |