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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116277856 | 11627785 | 6 | F | 20130223 | 20160826 | 20151014 | 20160901 | EXP | CA-ROCHE-1645417 | ROCHE | 65.19 | YR | F | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116277856 | 11627785 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E | 103976 | 150 | MG | SOLUTION FOR INJECTION | ||||||
| 116277856 | 11627785 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 116277856 | 11627785 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 116277856 | 11627785 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 116277856 | 11627785 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 116277856 | 11627785 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 116277856 | 11627785 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 116277856 | 11627785 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 116277856 | 11627785 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 116277856 | 11627785 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 116277856 | 11627785 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 116277856 | 11627785 | 12 | C | ZENHALE | FORMOTEROL FUMARATEMOMETASONE FUROATE | 1 | Unknown | U | 0 | ||||||||||
| 116277856 | 11627785 | 13 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | U | 0 | ||||||||||
| 116277856 | 11627785 | 14 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 116277856 | 11627785 | 15 | C | ALVESCO | CICLESONIDE | 1 | Unknown | U | 0 | ||||||||||
| 116277856 | 11627785 | 16 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116277856 | 11627785 | 1 | Asthma |
| 116277856 | 11627785 | 12 | Product used for unknown indication |
| 116277856 | 11627785 | 13 | Product used for unknown indication |
| 116277856 | 11627785 | 14 | Product used for unknown indication |
| 116277856 | 11627785 | 15 | Product used for unknown indication |
| 116277856 | 11627785 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116277856 | 11627785 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116277856 | 11627785 | Anaphylactoid reaction | |
| 116277856 | 11627785 | Back pain | |
| 116277856 | 11627785 | Body temperature decreased | |
| 116277856 | 11627785 | Cough | |
| 116277856 | 11627785 | Diarrhoea | |
| 116277856 | 11627785 | Dizziness | |
| 116277856 | 11627785 | Dry throat | |
| 116277856 | 11627785 | Epistaxis | |
| 116277856 | 11627785 | Facial bones fracture | |
| 116277856 | 11627785 | Faeces discoloured | |
| 116277856 | 11627785 | Fall | |
| 116277856 | 11627785 | Fatigue | |
| 116277856 | 11627785 | Formication | |
| 116277856 | 11627785 | Gingival disorder | |
| 116277856 | 11627785 | Haematoma | |
| 116277856 | 11627785 | Haemoptysis | |
| 116277856 | 11627785 | Haemorrhage | |
| 116277856 | 11627785 | Head injury | |
| 116277856 | 11627785 | Headache | |
| 116277856 | 11627785 | Impaired healing | |
| 116277856 | 11627785 | Incorrect drug administration rate | |
| 116277856 | 11627785 | Incorrect route of drug administration | |
| 116277856 | 11627785 | Increased tendency to bruise | |
| 116277856 | 11627785 | Influenza | |
| 116277856 | 11627785 | Injection site pruritus | |
| 116277856 | 11627785 | Injection site reaction | |
| 116277856 | 11627785 | Joint swelling | |
| 116277856 | 11627785 | Laceration | |
| 116277856 | 11627785 | Lacrimation increased | |
| 116277856 | 11627785 | Laryngitis | |
| 116277856 | 11627785 | Loss of consciousness | |
| 116277856 | 11627785 | Lymphadenopathy | |
| 116277856 | 11627785 | Malaise | |
| 116277856 | 11627785 | Musculoskeletal pain | |
| 116277856 | 11627785 | Myalgia | |
| 116277856 | 11627785 | Nasopharyngitis | |
| 116277856 | 11627785 | Odynophagia | |
| 116277856 | 11627785 | Oropharyngeal pain | |
| 116277856 | 11627785 | Pain in extremity | |
| 116277856 | 11627785 | Peripheral vascular disorder | |
| 116277856 | 11627785 | Rash | |
| 116277856 | 11627785 | Renal pain | |
| 116277856 | 11627785 | Rib fracture | |
| 116277856 | 11627785 | Sinus congestion | |
| 116277856 | 11627785 | Skin atrophy | |
| 116277856 | 11627785 | Skin injury | |
| 116277856 | 11627785 | Somnolence | |
| 116277856 | 11627785 | Spider vein | |
| 116277856 | 11627785 | Upper respiratory tract infection | |
| 116277856 | 11627785 | Urticaria | |
| 116277856 | 11627785 | Visual impairment | |
| 116277856 | 11627785 | 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 |
|---|---|---|---|---|---|---|
| 116277856 | 11627785 | 1 | 20130124 | 0 | ||
| 116277856 | 11627785 | 2 | 20130516 | 0 | ||
| 116277856 | 11627785 | 3 | 20130711 | 0 | ||
| 116277856 | 11627785 | 4 | 20131030 | 0 | ||
| 116277856 | 11627785 | 5 | 20131126 | 0 | ||
| 116277856 | 11627785 | 6 | 20140121 | 0 | ||
| 116277856 | 11627785 | 7 | 20140218 | 0 | ||
| 116277856 | 11627785 | 8 | 20150224 | 0 | ||
| 116277856 | 11627785 | 9 | 20150519 | 2015 | 0 | |
| 116277856 | 11627785 | 10 | 20160627 | 0 | ||
| 116277856 | 11627785 | 11 | 20160728 | 0 |