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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 101822475 | 10182247 | 5 | F | 20140508 | 20160830 | 20140520 | 20160904 | EXP | CA-ROCHE-1402901 | ROCHE | 58.67 | YR | F | Y | 59.00000 | KG | 20160905 | MD | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 101822475 | 10182247 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | ||||||
| 101822475 | 10182247 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | SOLUTION FOR INJECTION | |||||||||
| 101822475 | 10182247 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | SOLUTION FOR INJECTION | |||||||||
| 101822475 | 10182247 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | 300 | MG | SOLUTION FOR INJECTION | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 101822475 | 10182247 | 1 | Asthma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 101822475 | 10182247 | HO |
| 101822475 | 10182247 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 101822475 | 10182247 | Abdominal pain | |
| 101822475 | 10182247 | Asthma | |
| 101822475 | 10182247 | Crying | |
| 101822475 | 10182247 | Dysgeusia | |
| 101822475 | 10182247 | Epistaxis | |
| 101822475 | 10182247 | Fatigue | |
| 101822475 | 10182247 | Headache | |
| 101822475 | 10182247 | Malaise | |
| 101822475 | 10182247 | Nausea | |
| 101822475 | 10182247 | Oropharyngeal discomfort | |
| 101822475 | 10182247 | Pericarditis | |
| 101822475 | 10182247 | Pharyngeal oedema | |
| 101822475 | 10182247 | Swelling face | |
| 101822475 | 10182247 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 101822475 | 10182247 | 1 | 20140508 | 0 | ||
| 101822475 | 10182247 | 2 | 20140521 | 0 | ||
| 101822475 | 10182247 | 3 | 20140617 | 0 | ||
| 101822475 | 10182247 | 4 | 20160830 | 0 |