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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116533852 | 11653385 | 2 | F | 20160818 | 20151022 | 20160829 | EXP | US-BAXALTA-2015BLT002285 | BAXALTA | 0.00 | F | Y | 0.00000 | 20160829 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116533852 | 11653385 | 1 | PS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | UNK UNK, 2X A MONTH | U | 125105 | SOLUTION FOR INFUSION | ||||||||
| 116533852 | 11653385 | 2 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | UNK UNK, 2X A MONTH | U | 125105 | SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116533852 | 11653385 | 1 | Primary immunodeficiency syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116533852 | 11653385 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116533852 | 11653385 | Abnormal loss of weight | |
| 116533852 | 11653385 | Anaemia | |
| 116533852 | 11653385 | Anal incontinence | |
| 116533852 | 11653385 | Inability to afford medication | |
| 116533852 | 11653385 | Malaise | |
| 116533852 | 11653385 | Nausea | |
| 116533852 | 11653385 | Neuropathy peripheral | |
| 116533852 | 11653385 | Regurgitation | |
| 116533852 | 11653385 | Systemic lupus erythematosus |
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 |
|---|---|---|---|---|---|---|
| 116533852 | 11653385 | 2 | 20160806 | 0 |