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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125529291 | 12552929 | 1 | I | 20160524 | 20160704 | 20160713 | 20160713 | EXP | IE-BAXALTA-2016BLT004836 | BAXALTA | 82.74 | YR | F | Y | 59.00000 | KG | 20160713 | MD | IE | IE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125529291 | 12552929 | 1 | PS | KIOVIG | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 30ML FOR FIRST 30 MINUTES | LE12Q299AK | 125105 | 10 | G | SOLUTION FOR INFUSION | /month | |||||
| 125529291 | 12552929 | 2 | SS | KIOVIG | HUMAN IMMUNOGLOBULIN G | 1 | Unknown | UNK | 125105 | SOLUTION FOR INFUSION | |||||||||
| 125529291 | 12552929 | 3 | SS | RITUXIMAB | RITUXIMAB | 1 | Unknown | CYCLE 1, DAY 7 | 0 | ||||||||||
| 125529291 | 12552929 | 4 | SS | RED BLOOD CELLS | HUMAN RED BLOOD CELL | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125529291 | 12552929 | 1 | Infection prophylaxis |
| 125529291 | 12552929 | 3 | Product used for unknown indication |
| 125529291 | 12552929 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125529291 | 12552929 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125529291 | 12552929 | Adverse event | |
| 125529291 | 12552929 | Lower respiratory tract 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 |
|---|---|---|---|---|---|---|
| 125529291 | 12552929 | 1 | 20160603 | 0 | ||
| 125529291 | 12552929 | 2 | 201602 | 0 | ||
| 125529291 | 12552929 | 4 | 20160531 | 0 |