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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111302825 | 11130282 | 5 | F | 20150414 | 20160822 | 20150522 | 20160829 | EXP | CA-ROCHE-1580601 | ROCHE | 55.87 | YR | M | Y | 0.00000 | 20160829 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111302825 | 11130282 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062/S0060A,S0003B | 103976 | 300 | MG | SOLUTION FOR INJECTION | ||||||
| 111302825 | 11130282 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062/S0060A,S0003B | 103976 | 300 | MG | SOLUTION FOR INJECTION | ||||||
| 111302825 | 11130282 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062/S0060A,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 111302825 | 11130282 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062/S0060A,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 111302825 | 11130282 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062/S0060A,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 111302825 | 11130282 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062/S0060A,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 111302825 | 11130282 | 7 | SS | DIOVAN | VALSARTAN | 1 | Oral | U | 0 | ||||||||||
| 111302825 | 11130282 | 8 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | |||||||||||
| 111302825 | 11130282 | 9 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | |||||||||||
| 111302825 | 11130282 | 10 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 5 DAY COURSE | 0 | 50 | MG | QD | |||||||
| 111302825 | 11130282 | 11 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 5 DAY COURSE | 0 | 50 | MG | ||||||||
| 111302825 | 11130282 | 12 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 10 DAY COURSE | 0 | 50 | MG | ||||||||
| 111302825 | 11130282 | 13 | SS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | U | 0 | 18 | UG | ||||||||
| 111302825 | 11130282 | 14 | C | PANTOLOC | PANTOPRAZOLE SODIUM | 1 | Unknown | 0 | |||||||||||
| 111302825 | 11130282 | 15 | C | ALENDRONATE | ALENDRONATE SODIUM | 1 | Unknown | 0 | |||||||||||
| 111302825 | 11130282 | 16 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | 0 | |||||||||||
| 111302825 | 11130282 | 17 | C | IPRATROPIUM | IPRATROPIUM | 1 | Unknown | 0 | |||||||||||
| 111302825 | 11130282 | 18 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | 0 | |||||||||||
| 111302825 | 11130282 | 19 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | 0 | |||||||||||
| 111302825 | 11130282 | 20 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | 0 | |||||||||||
| 111302825 | 11130282 | 21 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111302825 | 11130282 | 1 | Asthma |
| 111302825 | 11130282 | 7 | Product used for unknown indication |
| 111302825 | 11130282 | 8 | Product used for unknown indication |
| 111302825 | 11130282 | 13 | Product used for unknown indication |
| 111302825 | 11130282 | 14 | Product used for unknown indication |
| 111302825 | 11130282 | 15 | Product used for unknown indication |
| 111302825 | 11130282 | 16 | Product used for unknown indication |
| 111302825 | 11130282 | 17 | Product used for unknown indication |
| 111302825 | 11130282 | 18 | Product used for unknown indication |
| 111302825 | 11130282 | 19 | Product used for unknown indication |
| 111302825 | 11130282 | 20 | Product used for unknown indication |
| 111302825 | 11130282 | 21 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111302825 | 11130282 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111302825 | 11130282 | Asthma | |
| 111302825 | 11130282 | Asthma-chronic obstructive pulmonary disease overlap syndrome | |
| 111302825 | 11130282 | Blood pressure systolic increased | |
| 111302825 | 11130282 | Chest discomfort | |
| 111302825 | 11130282 | Cough | |
| 111302825 | 11130282 | Cushing's syndrome | |
| 111302825 | 11130282 | Dyspnoea | |
| 111302825 | 11130282 | Dyspnoea exertional | |
| 111302825 | 11130282 | Forced expiratory volume decreased | |
| 111302825 | 11130282 | Heart rate increased | |
| 111302825 | 11130282 | Hypoventilation | |
| 111302825 | 11130282 | Obstructive airways disorder | |
| 111302825 | 11130282 | Productive cough | |
| 111302825 | 11130282 | Respiratory tract congestion | |
| 111302825 | 11130282 | Restrictive pulmonary disease | |
| 111302825 | 11130282 | Sensitivity to weather change | |
| 111302825 | 11130282 | Sputum discoloured | |
| 111302825 | 11130282 | Stress | |
| 111302825 | 11130282 | Upper respiratory tract infection | |
| 111302825 | 11130282 | Weight decreased | |
| 111302825 | 11130282 | 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 |
|---|---|---|---|---|---|---|
| 111302825 | 11130282 | 1 | 20120425 | 0 | ||
| 111302825 | 11130282 | 2 | 20150112 | 0 | ||
| 111302825 | 11130282 | 3 | 20160113 | 0 | ||
| 111302825 | 11130282 | 4 | 20160309 | 0 | ||
| 111302825 | 11130282 | 5 | 20160727 | 0 | ||
| 111302825 | 11130282 | 6 | 20160822 | 0 | ||
| 111302825 | 11130282 | 8 | 201508 | 0 | ||
| 111302825 | 11130282 | 9 | 201509 | 0 | ||
| 111302825 | 11130282 | 10 | 201511 | 0 | ||
| 111302825 | 11130282 | 11 | 201602 | 0 | ||
| 111302825 | 11130282 | 13 | 201510 | 0 |