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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 84548895 | 8454889 | 5 | F | 20120302 | 20160830 | 20120312 | 20160908 | EXP | CA-ROCHE-1047169 | ROCHE | 62.96 | YR | F | Y | 0.00000 | 20160908 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 84548895 | 8454889 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | ||||||
| 84548895 | 8454889 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | SOLUTION FOR INJECTION | |||||||||
| 84548895 | 8454889 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | SOLUTION FOR INJECTION | |||||||||
| 84548895 | 8454889 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 84548895 | 8454889 | 1 | Asthma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 84548895 | 8454889 | OT |
| 84548895 | 8454889 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 84548895 | 8454889 | Asthenia | |
| 84548895 | 8454889 | Blood pressure diastolic decreased | |
| 84548895 | 8454889 | Dyspnoea | |
| 84548895 | 8454889 | Heart rate increased | |
| 84548895 | 8454889 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 84548895 | 8454889 | 1 | 20110309 | 0 | ||
| 84548895 | 8454889 | 2 | 20120302 | 0 | ||
| 84548895 | 8454889 | 3 | 20121012 | 0 | ||
| 84548895 | 8454889 | 4 | 20130315 | 0 |