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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121697074 | 12169707 | 4 | F | 20160222 | 20160823 | 20160310 | 20160831 | EXP | US-BAXALTA-2016BLT001247 | BAXALTA | 62.89 | YR | M | Y | 102.00000 | KG | 20160830 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121697074 | 12169707 | 1 | PS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Subcutaneous | 10 G, 1X A WEEK | 125105 | 10 | G | SOLUTION FOR INFUSION | /wk | ||||||
| 121697074 | 12169707 | 2 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Subcutaneous | 10 G, ONCE | LE12Q258AB | 125105 | 10 | G | SOLUTION FOR INFUSION | 1X | |||||
| 121697074 | 12169707 | 3 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Subcutaneous | 10 G, ONCE | LE12QE87AC | 125105 | 10 | G | SOLUTION FOR INFUSION | 1X | |||||
| 121697074 | 12169707 | 4 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Subcutaneous | 10 G, ONCE | LE12QE87AC | 125105 | 10 | G | SOLUTION FOR INFUSION | 1X | |||||
| 121697074 | 12169707 | 5 | SS | GAMMAGARD LIQUID | HUMAN IMMUNOGLOBULIN G | 1 | Subcutaneous | 20 G, UNK | 125105 | 20 | G | SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121697074 | 12169707 | 1 | Immunodeficiency common variable |
| 121697074 | 12169707 | 2 | Primary immunodeficiency syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121697074 | 12169707 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121697074 | 12169707 | Bronchitis | |
| 121697074 | 12169707 | Condition aggravated | |
| 121697074 | 12169707 | Nasopharyngitis | |
| 121697074 | 12169707 | Sinusitis |
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 |
|---|---|---|---|---|---|---|
| 121697074 | 12169707 | 2 | 20160222 | 0 | ||
| 121697074 | 12169707 | 3 | 20160322 | 0 | ||
| 121697074 | 12169707 | 4 | 20160328 | 0 | ||
| 121697074 | 12169707 | 5 | 2016 | 0 |