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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119219563 | 11921956 | 3 | F | 20140724 | 20160912 | 20160115 | 20160920 | PER | US-BAXALTA-2016BLT000071 | BAXALTA | 29.39 | YR | F | Y | 0.00000 | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119219563 | 11921956 | 1 | PS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 40 G, EVERY 3 WK | Y | Y | LE12P113AB X2 | 125105 | 40 | G | SOLUTION FOR INFUSION | Q3W | |||
| 119219563 | 11921956 | 2 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 40 G, EVERY 3 WK | Y | Y | LE12P118AB X2 | 125105 | 40 | G | SOLUTION FOR INFUSION | Q3W | |||
| 119219563 | 11921956 | 3 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 40 G, EVERY 3 WK | Y | Y | LE12P144AB X2 | 125105 | 40 | G | SOLUTION FOR INFUSION | Q3W | |||
| 119219563 | 11921956 | 4 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 40 G, EVERY 3 WK | Y | Y | LE12P158AB X2 | 125105 | 40 | G | SOLUTION FOR INFUSION | Q3W | |||
| 119219563 | 11921956 | 5 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 20 G, EVERY 2 WK | Y | Y | LE12P176AB | 125105 | 20 | G | SOLUTION FOR INFUSION | QOW | |||
| 119219563 | 11921956 | 6 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 20 G, EVERY 2 WK | Y | Y | LE12P119AB | 125105 | 20 | G | SOLUTION FOR INFUSION | QOW | |||
| 119219563 | 11921956 | 7 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 20 G, EVERY 2 WK | Y | Y | LE12P119AB | 125105 | 20 | G | SOLUTION FOR INFUSION | QOW | |||
| 119219563 | 11921956 | 8 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 20 G, EVERY 2 WK | Y | Y | LE12P176AB | 125105 | 20 | G | SOLUTION FOR INFUSION | QOW | |||
| 119219563 | 11921956 | 9 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 20 G, EVERY 2 WK | Y | Y | LE12P119AB | 125105 | 20 | G | SOLUTION FOR INFUSION | QOW | |||
| 119219563 | 11921956 | 10 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 40 G, UNK | Y | Y | LE12P252AB X2 | 125105 | 40 | G | SOLUTION FOR INFUSION | ||||
| 119219563 | 11921956 | 11 | C | PRIVIGEN | HUMAN IMMUNOGLOBULIN G | 1 | Unknown | 60 G, LOADING DOSE | 0 | 60 | G | ||||||||
| 119219563 | 11921956 | 12 | C | PRIVIGEN | HUMAN IMMUNOGLOBULIN G | 1 | Unknown | 40 G, EVERY 3 WK | 0 | 40 | G | Q3W |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119219563 | 11921956 | 1 | Immunodeficiency common variable |
| 119219563 | 11921956 | 11 | Immunodeficiency common variable |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119219563 | 11921956 | Arthralgia | Arthralgia |
| 119219563 | 11921956 | Dizziness | |
| 119219563 | 11921956 | Exposure during pregnancy | |
| 119219563 | 11921956 | Headache | Headache |
| 119219563 | 11921956 | Malaise | Malaise |
| 119219563 | 11921956 | Nausea | Nausea |
| 119219563 | 11921956 | Pain | Pain |
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 |
|---|---|---|---|---|---|---|
| 119219563 | 11921956 | 1 | 20140724 | 20140924 | 0 | |
| 119219563 | 11921956 | 2 | 20140814 | 0 | ||
| 119219563 | 11921956 | 3 | 20140904 | 0 | ||
| 119219563 | 11921956 | 4 | 20140924 | 0 | ||
| 119219563 | 11921956 | 5 | 20141022 | 20141211 | 0 | |
| 119219563 | 11921956 | 6 | 20141103 | 0 | ||
| 119219563 | 11921956 | 7 | 20141113 | 0 | ||
| 119219563 | 11921956 | 8 | 20141201 | 0 | ||
| 119219563 | 11921956 | 9 | 20141211 | 0 | ||
| 119219563 | 11921956 | 10 | 20141230 | 20141230 | 0 | |
| 119219563 | 11921956 | 11 | 20140115 | 0 | ||
| 119219563 | 11921956 | 12 | 20140204 | 20140703 | 0 |