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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104799205 | 10479920 | 5 | F | 20140404 | 20160926 | 20140929 | 20160930 | EXP | CA-ROCHE-1466910 | ROCHE | 47.41 | YR | F | Y | 0.00000 | 20160930 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104799205 | 10479920 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 375 MG, BIW | U | S0066B | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | ||||
| 104799205 | 10479920 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0066B | 103976 | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 104799205 | 10479920 | 1 | Asthma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 104799205 | 10479920 | HO |
| 104799205 | 10479920 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 104799205 | 10479920 | Back pain | |
| 104799205 | 10479920 | Blood test abnormal | |
| 104799205 | 10479920 | Dyspnoea | |
| 104799205 | 10479920 | Fatigue | |
| 104799205 | 10479920 | Forced expiratory volume decreased | |
| 104799205 | 10479920 | Headache | |
| 104799205 | 10479920 | Malaise | |
| 104799205 | 10479920 | Nausea | |
| 104799205 | 10479920 | Neck pain | |
| 104799205 | 10479920 | Obstructive airways disorder | |
| 104799205 | 10479920 | Pyrexia | |
| 104799205 | 10479920 | Restrictive pulmonary disease | |
| 104799205 | 10479920 | Viraemia |
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 |
|---|---|---|---|---|---|---|
| 104799205 | 10479920 | 1 | 20140404 | 0 | ||
| 104799205 | 10479920 | 2 | 20160506 | 0 |