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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119998656 | 11999865 | 6 | F | 20120503 | 20160915 | 20160204 | 20160923 | EXP | CA-ROCHE-1706111 | ROCHE | 66.14 | YR | F | Y | 0.00000 | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119998656 | 11999865 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0065E,S00038 | 103976 | 300 | MG | SOLUTION FOR INJECTION | ||||||
| 119998656 | 11999865 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0065E,S00038 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119998656 | 11999865 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0065E,S00038 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119998656 | 11999865 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0065E,S00038 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119998656 | 11999865 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0065E,S00038 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119998656 | 11999865 | 6 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 119998656 | 11999865 | 7 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | U | 0 | ||||||||||
| 119998656 | 11999865 | 8 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | ||||||||||
| 119998656 | 11999865 | 9 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119998656 | 11999865 | 1 | Asthma |
| 119998656 | 11999865 | 6 | Product used for unknown indication |
| 119998656 | 11999865 | 7 | Product used for unknown indication |
| 119998656 | 11999865 | 8 | Product used for unknown indication |
| 119998656 | 11999865 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119998656 | 11999865 | HO |
| 119998656 | 11999865 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119998656 | 11999865 | Asthenia | |
| 119998656 | 11999865 | Asthma | |
| 119998656 | 11999865 | Blood pressure fluctuation | |
| 119998656 | 11999865 | Blood pressure increased | |
| 119998656 | 11999865 | Body temperature decreased | |
| 119998656 | 11999865 | Bronchitis | |
| 119998656 | 11999865 | Chest pain | |
| 119998656 | 11999865 | Chills | |
| 119998656 | 11999865 | Chronic obstructive pulmonary disease | |
| 119998656 | 11999865 | Cough | |
| 119998656 | 11999865 | Dizziness | |
| 119998656 | 11999865 | Dyspnoea | |
| 119998656 | 11999865 | Heart rate increased | |
| 119998656 | 11999865 | Hypotension | |
| 119998656 | 11999865 | Lymphadenopathy | |
| 119998656 | 11999865 | Myalgia | |
| 119998656 | 11999865 | Nasal congestion | |
| 119998656 | 11999865 | Pain | |
| 119998656 | 11999865 | Pyrexia | |
| 119998656 | 11999865 | Rhinorrhoea | |
| 119998656 | 11999865 | Secretion discharge | |
| 119998656 | 11999865 | Temperature intolerance |
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 |
|---|---|---|---|---|---|---|
| 119998656 | 11999865 | 1 | 20120404 | 0 | ||
| 119998656 | 11999865 | 2 | 20160418 | 0 | ||
| 119998656 | 11999865 | 3 | 20160519 | 0 | ||
| 119998656 | 11999865 | 4 | 20160811 | 0 | ||
| 119998656 | 11999865 | 5 | 20160915 | 0 |