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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111534048 | 11153404 | 8 | F | 20150422 | 20160926 | 20150602 | 20160929 | EXP | CA-ROCHE-1586676 | ROCHE | 49.94 | YR | M | Y | 0.00000 | 20160930 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111534048 | 11153404 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0065E,S0066B,S0003B,S0068D | 103976 | 225 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 111534048 | 11153404 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0065E,S0066B,S0003B,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||||
| 111534048 | 11153404 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0065E,S0066B,S0003B,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||||
| 111534048 | 11153404 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0065E,S0066B,S0003B,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||||
| 111534048 | 11153404 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0065E,S0066B,S0003B,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||||
| 111534048 | 11153404 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0065E,S0066B,S0003B,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||||
| 111534048 | 11153404 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0065E,S0066B,S0003B,S0068D | 103976 | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111534048 | 11153404 | 1 | Asthma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111534048 | 11153404 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111534048 | 11153404 | Anxiety | |
| 111534048 | 11153404 | Asthma | |
| 111534048 | 11153404 | Blood pressure increased | |
| 111534048 | 11153404 | Dyspnoea exertional | |
| 111534048 | 11153404 | Feeling abnormal | |
| 111534048 | 11153404 | Heart rate increased | |
| 111534048 | 11153404 | Lower respiratory tract congestion | |
| 111534048 | 11153404 | Nasopharyngitis | |
| 111534048 | 11153404 | Wheezing |
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 |
|---|---|---|---|---|---|---|
| 111534048 | 11153404 | 1 | 20150225 | 0 | ||
| 111534048 | 11153404 | 2 | 20150617 | 0 | ||
| 111534048 | 11153404 | 3 | 20160322 | 0 | ||
| 111534048 | 11153404 | 4 | 20160419 | 0 | ||
| 111534048 | 11153404 | 5 | 20160518 | 0 | ||
| 111534048 | 11153404 | 6 | 20160830 | 0 | ||
| 111534048 | 11153404 | 7 | 20160919 | 0 |