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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111638286 | 11163828 | 6 | F | 20141128 | 20160809 | 20150604 | 20160816 | EXP | CA-ROCHE-1588571 | ROCHE | 53.86 | YR | F | Y | 0.00000 | 20160816 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111638286 | 11163828 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | ||||||
| 111638286 | 11163828 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | SOLUTION FOR INJECTION | |||||||||
| 111638286 | 11163828 | 3 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | 0 | ||||||||||||
| 111638286 | 11163828 | 4 | C | SALBUTAMOL | ALBUTEROL | 1 | 0 | ||||||||||||
| 111638286 | 11163828 | 5 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | 0 | ||||||||||||
| 111638286 | 11163828 | 6 | C | PREDNISONE. | PREDNISONE | 1 | 0 | ||||||||||||
| 111638286 | 11163828 | 7 | C | ATROVENT | IPRATROPIUM BROMIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111638286 | 11163828 | 1 | Asthma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111638286 | 11163828 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111638286 | 11163828 | Asthenia | |
| 111638286 | 11163828 | Asthma | |
| 111638286 | 11163828 | Chest discomfort | |
| 111638286 | 11163828 | Drug ineffective | |
| 111638286 | 11163828 | Fatigue | |
| 111638286 | 11163828 | Fear of injection | |
| 111638286 | 11163828 | Headache | |
| 111638286 | 11163828 | Injection site pain | |
| 111638286 | 11163828 | Malaise | |
| 111638286 | 11163828 | 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 |
|---|---|---|---|---|---|---|
| 111638286 | 11163828 | 1 | 20141128 | 0 | ||
| 111638286 | 11163828 | 2 | 20160808 | 0 |