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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125898971 | 12589897 | 1 | I | 20160713 | 20160509 | 20160725 | 20160725 | EXP | US-BAXALTA-2016BLT003268 | BAXALTA | 25.81 | YR | F | Y | 82.00000 | KG | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125898971 | 12589897 | 1 | PS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Subcutaneous | 15 G, 1X A WEEK | LE12R001AD | 125105 | 15 | G | SOLUTION FOR INFUSION | /wk | |||||
| 125898971 | 12589897 | 2 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Subcutaneous | 15 G, 1X A WEEK | LE12Q396AC | 125105 | 15 | G | SOLUTION FOR INFUSION | /wk | |||||
| 125898971 | 12589897 | 3 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Subcutaneous | 15 G, 1X A WEEK | 125105 | 15 | G | SOLUTION FOR INFUSION | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125898971 | 12589897 | 1 | Primary immunodeficiency syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125898971 | 12589897 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125898971 | 12589897 | Anaphylactic reaction | |
| 125898971 | 12589897 | Cataract | |
| 125898971 | 12589897 | Headache | |
| 125898971 | 12589897 | Hypersensitivity | |
| 125898971 | 12589897 | Rubber sensitivity |
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 |
|---|---|---|---|---|---|---|
| 125898971 | 12589897 | 1 | 20160713 | 20160713 | 0 | |
| 125898971 | 12589897 | 2 | 201607 | 201607 | 0 |