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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125977302 | 12597730 | 2 | F | 2016 | 20160727 | 20160726 | 20160803 | EXP | US-BAXALTA-2016BLT005379 | BAXALTA | 64.94 | YR | M | Y | 0.00000 | 20160803 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125977302 | 12597730 | 1 | PS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Unknown | 40 G, ONCE | Y | LE12Q338AB | 125105 | 40 | G | SOLUTION FOR INFUSION | 1X | ||||
| 125977302 | 12597730 | 2 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Y | 125105 | SOLUTION FOR INFUSION | ||||||||||
| 125977302 | 12597730 | 3 | SS | GAMUNEX-C | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 40 G, FOR FIVE CONSECUTIVE DAYS | 200 | G | Y | 0 | 40 | G | QD | ||||
| 125977302 | 12597730 | 4 | SS | GAMUNEX-C | HUMAN IMMUNOGLOBULIN G | 1 | 200 | G | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125977302 | 12597730 | 1 | Demyelinating polyneuropathy |
| 125977302 | 12597730 | 2 | Off label use |
| 125977302 | 12597730 | 3 | Demyelinating polyneuropathy |
| 125977302 | 12597730 | 4 | Lewis-Sumner syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125977302 | 12597730 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125977302 | 12597730 | Alopecia | |
| 125977302 | 12597730 | Blood glucose increased | |
| 125977302 | 12597730 | Chills | |
| 125977302 | 12597730 | Dehydration | |
| 125977302 | 12597730 | Discomfort | |
| 125977302 | 12597730 | Hypersensitivity | |
| 125977302 | 12597730 | Mobility decreased | |
| 125977302 | 12597730 | Oedema peripheral | |
| 125977302 | 12597730 | Pruritus | |
| 125977302 | 12597730 | Rash | |
| 125977302 | 12597730 | Skin exfoliation | |
| 125977302 | 12597730 | Skin fissures | |
| 125977302 | 12597730 | Swelling | |
| 125977302 | 12597730 | Temperature regulation disorder | |
| 125977302 | 12597730 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 125977302 | 12597730 | 1 | 20160421 | 20160421 | 0 | |
| 125977302 | 12597730 | 3 | 20160404 | 20160408 | 0 |