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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116921764 | 11692176 | 4 | F | 20120416 | 20160922 | 20151103 | 20160928 | EXP | CA-ROCHE-1652064 | ROCHE | 37.39 | YR | M | Y | 0.00000 | 20160928 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116921764 | 11692176 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, EVERY FOUR WEEKS | U | S0002F,S0065E | 103976 | 300 | MG | SOLUTION FOR INJECTION | |||||
| 116921764 | 11692176 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0002F,S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 116921764 | 11692176 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0002F,S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 116921764 | 11692176 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0002F,S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 116921764 | 11692176 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0002F,S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 116921764 | 11692176 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0002F,S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 116921764 | 11692176 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0002F,S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 116921764 | 11692176 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0002F,S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 116921764 | 11692176 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0002F,S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 116921764 | 11692176 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0002F,S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 116921764 | 11692176 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0002F,S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 116921764 | 11692176 | 12 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0002F,S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 116921764 | 11692176 | 13 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | U | 0 | ||||||||||
| 116921764 | 11692176 | 14 | C | ALVESCO | CICLESONIDE | 1 | Unknown | U | 0 | ||||||||||
| 116921764 | 11692176 | 15 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 116921764 | 11692176 | 16 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | Y | 0 | ||||||||||
| 116921764 | 11692176 | 17 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | Y | 0 | ||||||||||
| 116921764 | 11692176 | 18 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | FOR 4 DAYS | Y | 0 | 50 | MG | QD | ||||||
| 116921764 | 11692176 | 19 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 50 MG, FOR 4 DAYS | Y | 0 | 50 | MG | |||||||
| 116921764 | 11692176 | 20 | C | ATROVENT | IPRATROPIUM BROMIDE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116921764 | 11692176 | 1 | Asthma |
| 116921764 | 11692176 | 13 | Product used for unknown indication |
| 116921764 | 11692176 | 14 | Product used for unknown indication |
| 116921764 | 11692176 | 15 | Product used for unknown indication |
| 116921764 | 11692176 | 16 | Product used for unknown indication |
| 116921764 | 11692176 | 17 | Product used for unknown indication |
| 116921764 | 11692176 | 20 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116921764 | 11692176 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116921764 | 11692176 | Alopecia | |
| 116921764 | 11692176 | Asthma | |
| 116921764 | 11692176 | Chest discomfort | |
| 116921764 | 11692176 | Condition aggravated | |
| 116921764 | 11692176 | Cough | |
| 116921764 | 11692176 | Dyspnoea | |
| 116921764 | 11692176 | Fear of injection | |
| 116921764 | 11692176 | Hypersensitivity | |
| 116921764 | 11692176 | Influenza like illness | |
| 116921764 | 11692176 | Injection site bruising | |
| 116921764 | 11692176 | Injection site pain | |
| 116921764 | 11692176 | Injection site paraesthesia | |
| 116921764 | 11692176 | Injection site pruritus | |
| 116921764 | 11692176 | Lower respiratory tract infection | |
| 116921764 | 11692176 | Lymphadenopathy | |
| 116921764 | 11692176 | Malaise | |
| 116921764 | 11692176 | Pain in extremity | |
| 116921764 | 11692176 | Procedural complication | |
| 116921764 | 11692176 | Pyrexia | |
| 116921764 | 11692176 | Respiratory disorder | |
| 116921764 | 11692176 | Weight decreased | |
| 116921764 | 11692176 | 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 |
|---|---|---|---|---|---|---|
| 116921764 | 11692176 | 1 | 20120416 | 0 | ||
| 116921764 | 11692176 | 2 | 20120611 | 0 | ||
| 116921764 | 11692176 | 3 | 20130715 | 0 | ||
| 116921764 | 11692176 | 4 | 20140303 | 0 | ||
| 116921764 | 11692176 | 5 | 20141210 | 0 | ||
| 116921764 | 11692176 | 6 | 20150505 | 0 | ||
| 116921764 | 11692176 | 7 | 20150630 | 0 | ||
| 116921764 | 11692176 | 8 | 20151020 | 0 | ||
| 116921764 | 11692176 | 9 | 20160505 | 0 | ||
| 116921764 | 11692176 | 10 | 20160629 | 0 | ||
| 116921764 | 11692176 | 11 | 20160728 | 0 | ||
| 116921764 | 11692176 | 12 | 20160922 | 0 |