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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122492133 | 12249213 | 3 | F | 20160920 | 20160408 | 20160923 | EXP | CA-BAXALTA-2016BLT002205 | BAXALTA | PENDERGRAST, JACOB; WILLIE-RAMHARACK, KEZIA; SAMPSON, LORNA; LAROCHE, VINCENT; BRANCH, DONALD;. PATHOGENESIS AND EPIDEMIOLOGY OF IG PRODUCT-RELATED HEMOLYSIS. THE ROLE OF INFLAMMATION IN INTRAVENOUS IMMUNE GLOBULIN-MEDIATED HEMOLYSIS.. TRANSFUSION. 2015;55:S65-S73 | 82.00 | YR | F | Y | 0.00000 | 20160923 | MD | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122492133 | 12249213 | 1 | PS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 2000 MG/KG, TOTAL | U | 125105 | 2000 | MG/KG | SOLUTION FOR INFUSION | 1X | |||||
| 122492133 | 12249213 | 2 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | U | 125105 | SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122492133 | 12249213 | 1 | Polyneuropathy |
| 122492133 | 12249213 | 2 | Off label use |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122492133 | 12249213 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122492133 | 12249213 | Haemolysis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |