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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106568298 | 10656829 | 8 | F | 2012 | 20160630 | 20141217 | 20160711 | EXP | CA-ROCHE-1126813 | ROCHE | 58.67 | YR | F | Y | 0.00000 | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106568298 | 10656829 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 106568298 | 10656829 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F | 103976 | |||||||||
| 106568298 | 10656829 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F | 103976 | |||||||||
| 106568298 | 10656829 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F | 103976 | |||||||||
| 106568298 | 10656829 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0066B,S0002F | 103976 | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 106568298 | 10656829 | 1 | Asthma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 106568298 | 10656829 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 106568298 | 10656829 | Benign breast neoplasm | |
| 106568298 | 10656829 | Dysphonia | |
| 106568298 | 10656829 | Herpes zoster | |
| 106568298 | 10656829 | Hypersensitivity | |
| 106568298 | 10656829 | Nasopharyngitis | |
| 106568298 | 10656829 | Oropharyngeal pain | |
| 106568298 | 10656829 | Pharyngitis | |
| 106568298 | 10656829 | Respiratory disorder | |
| 106568298 | 10656829 | Respiratory rate increased | |
| 106568298 | 10656829 | Respiratory tract congestion | |
| 106568298 | 10656829 | Rhinitis | |
| 106568298 | 10656829 | Urinary tract infection | |
| 106568298 | 10656829 | Wound complication |
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 |
|---|---|---|---|---|---|---|
| 106568298 | 10656829 | 1 | 20110216 | 0 | ||
| 106568298 | 10656829 | 2 | 20141209 | 0 | ||
| 106568298 | 10656829 | 3 | 20160311 | 0 | ||
| 106568298 | 10656829 | 4 | 20160505 | 0 | ||
| 106568298 | 10656829 | 5 | 20160614 | 0 |