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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119930917 | 11993091 | 7 | F | 20121126 | 20160810 | 20160203 | 20160817 | EXP | CA-ROCHE-1703558 | ROCHE | 49.47 | YR | F | Y | 0.00000 | 20160817 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119930917 | 11993091 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 119930917 | 11993091 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 12 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 13 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 14 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 15 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 16 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 17 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 18 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 19 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 20 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 21 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 22 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 23 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 24 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 25 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 26 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 27 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 28 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 29 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 30 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 31 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 32 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 33 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 34 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 35 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 36 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 37 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0002,S0001C,S0060,S0062,S0065E,S00 | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119930917 | 11993091 | 38 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 119930917 | 11993091 | 39 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | U | 0 | ||||||||||
| 119930917 | 11993091 | 40 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | U | 0 | ||||||||||
| 119930917 | 11993091 | 41 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119930917 | 11993091 | 1 | Asthma |
| 119930917 | 11993091 | 38 | Product used for unknown indication |
| 119930917 | 11993091 | 39 | Product used for unknown indication |
| 119930917 | 11993091 | 40 | Product used for unknown indication |
| 119930917 | 11993091 | 41 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119930917 | 11993091 | HO |
| 119930917 | 11993091 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119930917 | 11993091 | Asthma | |
| 119930917 | 11993091 | Chest discomfort | |
| 119930917 | 11993091 | Cough | |
| 119930917 | 11993091 | Discomfort | |
| 119930917 | 11993091 | Dizziness | |
| 119930917 | 11993091 | Headache | |
| 119930917 | 11993091 | Humidity intolerance | |
| 119930917 | 11993091 | Injection site erythema | |
| 119930917 | 11993091 | Injection site swelling | |
| 119930917 | 11993091 | Malaise | |
| 119930917 | 11993091 | Nephrolithiasis | |
| 119930917 | 11993091 | Pyelonephritis | |
| 119930917 | 11993091 | Rales | |
| 119930917 | 11993091 | Respiratory disorder | |
| 119930917 | 11993091 | Rhonchi | |
| 119930917 | 11993091 | Speech disorder | |
| 119930917 | 11993091 | Temperature intolerance | |
| 119930917 | 11993091 | Weight decreased | |
| 119930917 | 11993091 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 119930917 | 11993091 | 1 | 20120820 | 0 | ||
| 119930917 | 11993091 | 2 | 20121112 | 0 | ||
| 119930917 | 11993091 | 3 | 20121126 | 0 | ||
| 119930917 | 11993091 | 4 | 20130204 | 0 | ||
| 119930917 | 11993091 | 5 | 20130318 | 0 | ||
| 119930917 | 11993091 | 6 | 20130417 | 0 | ||
| 119930917 | 11993091 | 7 | 20130429 | 0 | ||
| 119930917 | 11993091 | 8 | 20130515 | 0 | ||
| 119930917 | 11993091 | 9 | 20130612 | 0 | ||
| 119930917 | 11993091 | 10 | 20130731 | 0 | ||
| 119930917 | 11993091 | 11 | 20130814 | 0 | ||
| 119930917 | 11993091 | 12 | 20130827 | 0 | ||
| 119930917 | 11993091 | 13 | 20131008 | 0 | ||
| 119930917 | 11993091 | 14 | 20131105 | 0 | ||
| 119930917 | 11993091 | 15 | 20131119 | 0 | ||
| 119930917 | 11993091 | 16 | 20140114 | 0 | ||
| 119930917 | 11993091 | 17 | 20140211 | 0 | ||
| 119930917 | 11993091 | 18 | 20140225 | 0 | ||
| 119930917 | 11993091 | 19 | 20140520 | 0 | ||
| 119930917 | 11993091 | 20 | 20140603 | 0 | ||
| 119930917 | 11993091 | 21 | 20141007 | 0 | ||
| 119930917 | 11993091 | 22 | 20141104 | 0 | ||
| 119930917 | 11993091 | 23 | 20141118 | 0 | ||
| 119930917 | 11993091 | 24 | 20141216 | 0 | ||
| 119930917 | 11993091 | 25 | 20150113 | 0 | ||
| 119930917 | 11993091 | 26 | 20150224 | 0 | ||
| 119930917 | 11993091 | 27 | 20150421 | 0 | ||
| 119930917 | 11993091 | 28 | 20150616 | 0 | ||
| 119930917 | 11993091 | 29 | 20150630 | 0 | ||
| 119930917 | 11993091 | 30 | 20150825 | 0 | ||
| 119930917 | 11993091 | 31 | 20151103 | 0 | ||
| 119930917 | 11993091 | 32 | 20160323 | 0 | ||
| 119930917 | 11993091 | 33 | 20160504 | 0 | ||
| 119930917 | 11993091 | 34 | 20160517 | 0 | ||
| 119930917 | 11993091 | 35 | 20160601 | 0 | ||
| 119930917 | 11993091 | 36 | 20160614 | 0 | ||
| 119930917 | 11993091 | 37 | 20160726 | 0 |