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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114089848 | 11408984 | 8 | F | 20121203 | 20160811 | 20150824 | 20160819 | EXP | CA-ROCHE-1624077 | ROCHE | 43.92 | YR | M | Y | 0.00000 | 20160819 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114089848 | 11408984 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0059B,S0062,S0061D,S0066B | 103976 | 300 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 114089848 | 11408984 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0059B,S0062,S0061D,S0066B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 114089848 | 11408984 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0059B,S0062,S0061D,S0066B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 114089848 | 11408984 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0059B,S0062,S0061D,S0066B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 114089848 | 11408984 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0059B,S0062,S0061D,S0066B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 114089848 | 11408984 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0059B,S0062,S0061D,S0066B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 114089848 | 11408984 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0059B,S0062,S0061D,S0066B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 114089848 | 11408984 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0059B,S0062,S0061D,S0066B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 114089848 | 11408984 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0059B,S0062,S0061D,S0066B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 114089848 | 11408984 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0059B,S0062,S0061D,S0066B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 114089848 | 11408984 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0059B,S0062,S0061D,S0066B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 114089848 | 11408984 | 12 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0059B,S0062,S0061D,S0066B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 114089848 | 11408984 | 13 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0059B,S0062,S0061D,S0066B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 114089848 | 11408984 | 14 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0059B,S0062,S0061D,S0066B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 114089848 | 11408984 | 15 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0059B,S0062,S0061D,S0066B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 114089848 | 11408984 | 16 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0059B,S0062,S0061D,S0066B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 114089848 | 11408984 | 17 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0059B,S0062,S0061D,S0066B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 114089848 | 11408984 | 18 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 114089848 | 11408984 | 19 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 114089848 | 11408984 | 20 | C | ATROVENT | IPRATROPIUM BROMIDE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114089848 | 11408984 | 1 | Asthma |
| 114089848 | 11408984 | 18 | Product used for unknown indication |
| 114089848 | 11408984 | 19 | Product used for unknown indication |
| 114089848 | 11408984 | 20 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114089848 | 11408984 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114089848 | 11408984 | Asthma | |
| 114089848 | 11408984 | Blood pressure diastolic decreased | |
| 114089848 | 11408984 | Body temperature decreased | |
| 114089848 | 11408984 | Chest discomfort | |
| 114089848 | 11408984 | Ear infection | |
| 114089848 | 11408984 | Fatigue | |
| 114089848 | 11408984 | Hypersensitivity | |
| 114089848 | 11408984 | Influenza | |
| 114089848 | 11408984 | Lower respiratory tract congestion | |
| 114089848 | 11408984 | Lower respiratory tract infection | |
| 114089848 | 11408984 | Malaise | |
| 114089848 | 11408984 | Nasal congestion | |
| 114089848 | 11408984 | Nasopharyngitis | |
| 114089848 | 11408984 | Oropharyngeal pain | |
| 114089848 | 11408984 | Pain | |
| 114089848 | 11408984 | Productive cough | |
| 114089848 | 11408984 | Pyrexia | |
| 114089848 | 11408984 | Respiratory disorder | |
| 114089848 | 11408984 | Rhinorrhoea | |
| 114089848 | 11408984 | Rhonchi | |
| 114089848 | 11408984 | Sputum discoloured | |
| 114089848 | 11408984 | Upper respiratory tract infection | |
| 114089848 | 11408984 | Weight decreased | |
| 114089848 | 11408984 | 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 |
|---|---|---|---|---|---|---|
| 114089848 | 11408984 | 1 | 20121203 | 0 | ||
| 114089848 | 11408984 | 2 | 20130228 | 0 | ||
| 114089848 | 11408984 | 3 | 20130704 | 0 | ||
| 114089848 | 11408984 | 4 | 20130801 | 0 | ||
| 114089848 | 11408984 | 5 | 20130912 | 0 | ||
| 114089848 | 11408984 | 6 | 20140116 | 0 | ||
| 114089848 | 11408984 | 7 | 20140408 | 0 | ||
| 114089848 | 11408984 | 8 | 20140605 | 0 | ||
| 114089848 | 11408984 | 9 | 20140717 | 0 | ||
| 114089848 | 11408984 | 10 | 20150115 | 0 | ||
| 114089848 | 11408984 | 11 | 20150819 | 0 | ||
| 114089848 | 11408984 | 12 | 20150827 | 0 | ||
| 114089848 | 11408984 | 13 | 20160211 | 0 | ||
| 114089848 | 11408984 | 14 | 20160309 | 0 | ||
| 114089848 | 11408984 | 15 | 20160330 | 0 | ||
| 114089848 | 11408984 | 16 | 20160728 | 0 | ||
| 114089848 | 11408984 | 17 | 20160811 | 0 |