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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115507255 | 11550725 | 5 | F | 20130108 | 20160804 | 20150924 | 20160811 | EXP | CA-ROCHE-1636716 | ROCHE | 51.93 | YR | M | Y | 0.00000 | 20160811 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115507255 | 11550725 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0061D,S0002F | 103976 | 300 | MG | SOLUTION FOR INJECTION | ||||||
| 115507255 | 11550725 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0061D,S0002F | 103976 | SOLUTION FOR INJECTION | ||||||||
| 115507255 | 11550725 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0061D,S0002F | 103976 | SOLUTION FOR INJECTION | ||||||||
| 115507255 | 11550725 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0061D,S0002F | 103976 | SOLUTION FOR INJECTION | ||||||||
| 115507255 | 11550725 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0061D,S0002F | 103976 | SOLUTION FOR INJECTION | ||||||||
| 115507255 | 11550725 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0061D,S0002F | 103976 | SOLUTION FOR INJECTION | ||||||||
| 115507255 | 11550725 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0061D,S0002F | 103976 | SOLUTION FOR INJECTION | ||||||||
| 115507255 | 11550725 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0061D,S0002F | 103976 | SOLUTION FOR INJECTION | ||||||||
| 115507255 | 11550725 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0061D,S0002F | 103976 | SOLUTION FOR INJECTION | ||||||||
| 115507255 | 11550725 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0061D,S0002F | 103976 | SOLUTION FOR INJECTION | ||||||||
| 115507255 | 11550725 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0061D,S0002F | 103976 | SOLUTION FOR INJECTION | ||||||||
| 115507255 | 11550725 | 12 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0061D,S0002F | 103976 | SOLUTION FOR INJECTION | ||||||||
| 115507255 | 11550725 | 13 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0061D,S0002F | 103976 | SOLUTION FOR INJECTION | ||||||||
| 115507255 | 11550725 | 14 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0061D,S0002F | 103976 | SOLUTION FOR INJECTION | ||||||||
| 115507255 | 11550725 | 15 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0061D,S0002F | 103976 | SOLUTION FOR INJECTION | ||||||||
| 115507255 | 11550725 | 16 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0061D,S0002F | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 115507255 | 11550725 | 17 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 5 MG, QD | U | 0 | 5 | MG | QD | ||||||
| 115507255 | 11550725 | 18 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115507255 | 11550725 | 1 | Asthma |
| 115507255 | 11550725 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115507255 | 11550725 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115507255 | 11550725 | Anxiety | |
| 115507255 | 11550725 | Asthma | |
| 115507255 | 11550725 | Body temperature decreased | |
| 115507255 | 11550725 | Chest discomfort | |
| 115507255 | 11550725 | Cough | |
| 115507255 | 11550725 | Dysgeusia | |
| 115507255 | 11550725 | Dyspnoea | |
| 115507255 | 11550725 | Fatigue | |
| 115507255 | 11550725 | Influenza | |
| 115507255 | 11550725 | Lung infection | |
| 115507255 | 11550725 | Nasopharyngitis | |
| 115507255 | 11550725 | Oxygen saturation decreased | |
| 115507255 | 11550725 | Pulmonary congestion | |
| 115507255 | 11550725 | Respiratory disorder | |
| 115507255 | 11550725 | Rhonchi | |
| 115507255 | 11550725 | Seasonal allergy | |
| 115507255 | 11550725 | Weight decreased | |
| 115507255 | 11550725 | 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 |
|---|---|---|---|---|---|---|
| 115507255 | 11550725 | 1 | 20130108 | 0 | ||
| 115507255 | 11550725 | 2 | 20130626 | 0 | ||
| 115507255 | 11550725 | 3 | 20131002 | 0 | ||
| 115507255 | 11550725 | 4 | 20131113 | 0 | ||
| 115507255 | 11550725 | 5 | 20140122 | 0 | ||
| 115507255 | 11550725 | 6 | 20140205 | 0 | ||
| 115507255 | 11550725 | 7 | 20140702 | 0 | ||
| 115507255 | 11550725 | 8 | 2014 | 0 | ||
| 115507255 | 11550725 | 9 | 20140902 | 0 | ||
| 115507255 | 11550725 | 10 | 20150804 | 0 | ||
| 115507255 | 11550725 | 11 | 20150915 | 0 | ||
| 115507255 | 11550725 | 12 | 20151001 | 0 | ||
| 115507255 | 11550725 | 13 | 20160414 | 0 | ||
| 115507255 | 11550725 | 14 | 20160705 | 0 | ||
| 115507255 | 11550725 | 15 | 20160721 | 0 | ||
| 115507255 | 11550725 | 16 | 20160428 | 0 |