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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126161601 | 12616160 | 1 | I | 2011 | 20160725 | 20160802 | 20160802 | EXP | US-BAXALTA-2016BLT005510 | BAXALTA | 42.52 | YR | F | Y | 69.40000 | KG | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126161601 | 12616160 | 1 | PS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | UNK | Y | 125105 | SOLUTION FOR INFUSION | ||||||||
| 126161601 | 12616160 | 2 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Subcutaneous | UNK | Y | 125105 | SOLUTION FOR INFUSION | ||||||||
| 126161601 | 12616160 | 3 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | UNK, 1X A MONTH | Y | 125105 | SOLUTION FOR INFUSION | /month | |||||||
| 126161601 | 12616160 | 4 | SS | HIZENTRA | HUMAN IMMUNOGLOBULIN G | 1 | Unknown | UNK | U | 0 | |||||||||
| 126161601 | 12616160 | 5 | SS | PRIVIGEN | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | UNK | U | 0 | |||||||||
| 126161601 | 12616160 | 6 | SS | FLEBOGAMMA 5% | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | UNK | U | 0 | |||||||||
| 126161601 | 12616160 | 7 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126161601 | 12616160 | 8 | C | TRADJENTA | LINAGLIPTIN | 1 | 0 | ||||||||||||
| 126161601 | 12616160 | 9 | C | INSULIN | INSULIN NOS | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126161601 | 12616160 | 1 | Primary immunodeficiency syndrome |
| 126161601 | 12616160 | 4 | Product used for unknown indication |
| 126161601 | 12616160 | 5 | Product used for unknown indication |
| 126161601 | 12616160 | 6 | Primary immunodeficiency syndrome |
| 126161601 | 12616160 | 7 | Diabetes mellitus |
| 126161601 | 12616160 | 8 | Diabetes mellitus |
| 126161601 | 12616160 | 9 | Diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126161601 | 12616160 | HO |
| 126161601 | 12616160 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126161601 | 12616160 | Arthralgia | |
| 126161601 | 12616160 | Back pain | |
| 126161601 | 12616160 | Blood creatine abnormal | |
| 126161601 | 12616160 | Blood glucose abnormal | |
| 126161601 | 12616160 | Bone pain | |
| 126161601 | 12616160 | Bronchitis | |
| 126161601 | 12616160 | Dehydration | |
| 126161601 | 12616160 | Fall | |
| 126161601 | 12616160 | Granuloma | |
| 126161601 | 12616160 | Headache | |
| 126161601 | 12616160 | Immunoglobulins abnormal | |
| 126161601 | 12616160 | Kidney infection | |
| 126161601 | 12616160 | Nausea | |
| 126161601 | 12616160 | Renal failure | |
| 126161601 | 12616160 | Sinusitis | |
| 126161601 | 12616160 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 126161601 | 12616160 | 1 | 2011 | 2012 | 0 | |
| 126161601 | 12616160 | 2 | 2012 | 2012 | 0 | |
| 126161601 | 12616160 | 3 | 2015 | 201604 | 0 |