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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126531711 | 12653171 | 1 | I | 20151224 | 20160728 | 20160815 | 20160815 | EXP | US-BAXALTA-2016BLT005601 | BAXALTA | 66.37 | YR | F | Y | 0.00000 | 20160815 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126531711 | 12653171 | 1 | PS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 1X A MONTH | U | 125105 | SOLUTION FOR INFUSION | /month | |||||||
| 126531711 | 12653171 | 2 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | U | 125105 | SOLUTION FOR INFUSION | ||||||||||
| 126531711 | 12653171 | 3 | SS | HYALURONIDASE/IMMUNOGLOBULIN, NORMAL HUMAN | HUMAN IMMUNOGLOBULIN GHYALURONIDASE RECOMBINANT HUMAN | 1 | Subcutaneous | 1X A MONTH | 0 | SOLUTION FOR INFUSION | /month | ||||||||
| 126531711 | 12653171 | 4 | SS | HYALURONIDASE/IMMUNOGLOBULIN, NORMAL HUMAN | HUMAN IMMUNOGLOBULIN GHYALURONIDASE RECOMBINANT HUMAN | 1 | 0 | SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126531711 | 12653171 | 1 | Primary immunodeficiency syndrome |
| 126531711 | 12653171 | 2 | Immunodeficiency common variable |
| 126531711 | 12653171 | 3 | Primary immunodeficiency syndrome |
| 126531711 | 12653171 | 4 | Immunodeficiency common variable |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126531711 | 12653171 | HO |
| 126531711 | 12653171 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126531711 | 12653171 | Arthropathy | |
| 126531711 | 12653171 | Drug dose omission | |
| 126531711 | 12653171 | Fall | |
| 126531711 | 12653171 | Infusion site pain | |
| 126531711 | 12653171 | Intervertebral disc compression | |
| 126531711 | 12653171 | Laceration | |
| 126531711 | 12653171 | Osteoarthritis | |
| 126531711 | 12653171 | Pneumonia | |
| 126531711 | 12653171 | Spinal fusion acquired | |
| 126531711 | 12653171 | Vascular access site rupture | |
| 126531711 | 12653171 | Wound infection |
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 |
|---|---|---|---|---|---|---|
| 126531711 | 12653171 | 1 | 201107 | 201410 | 0 | |
| 126531711 | 12653171 | 3 | 201410 | 0 |