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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112159879 | 11215987 | 9 | F | 20130812 | 20160913 | 20150624 | 20160919 | EXP | CA-ROCHE-1598624 | ROCHE | 64.37 | YR | F | Y | 0.00000 | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112159879 | 11215987 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, BIW (EVERY 2 WEEKS) | U | S0059B,S0060A,S0066B,S0068D | 103976 | 300 | MG | SOLUTION FOR INJECTION | QOW | ||||
| 112159879 | 11215987 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0059B,S0060A,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 112159879 | 11215987 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0059B,S0060A,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 112159879 | 11215987 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0059B,S0060A,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 112159879 | 11215987 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0059B,S0060A,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 112159879 | 11215987 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0059B,S0060A,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 112159879 | 11215987 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK, BIW | U | S0059B,S0060A,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | QOW | ||||||
| 112159879 | 11215987 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0059B,S0060A,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 112159879 | 11215987 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0059B,S0060A,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 112159879 | 11215987 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0059B,S0060A,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 112159879 | 11215987 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0059B,S0060A,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 112159879 | 11215987 | 12 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0059B,S0060A,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 112159879 | 11215987 | 13 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0059B,S0060A,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 112159879 | 11215987 | 14 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 112159879 | 11215987 | 15 | C | REACTINE (CANADA) | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | UNK, BID (IN THE MORNING AND AFTERNOON) | U | 0 | BID | ||||||||
| 112159879 | 11215987 | 16 | C | FLOVENT | FLUTICASONE PROPIONATE | 1 | Unknown | U | 0 | ||||||||||
| 112159879 | 11215987 | 17 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112159879 | 11215987 | 1 | Asthma |
| 112159879 | 11215987 | 14 | Product used for unknown indication |
| 112159879 | 11215987 | 15 | Urticaria |
| 112159879 | 11215987 | 16 | Product used for unknown indication |
| 112159879 | 11215987 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112159879 | 11215987 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112159879 | 11215987 | Abdominal distension | |
| 112159879 | 11215987 | Arthralgia | |
| 112159879 | 11215987 | Asthenia | |
| 112159879 | 11215987 | Blood count abnormal | |
| 112159879 | 11215987 | Blood glucose increased | |
| 112159879 | 11215987 | Blood pressure systolic increased | |
| 112159879 | 11215987 | Bronchitis | |
| 112159879 | 11215987 | Contusion | |
| 112159879 | 11215987 | Dizziness | |
| 112159879 | 11215987 | Dry throat | |
| 112159879 | 11215987 | Ear infection | |
| 112159879 | 11215987 | Fall | |
| 112159879 | 11215987 | Headache | |
| 112159879 | 11215987 | Influenza | |
| 112159879 | 11215987 | Influenza like illness | |
| 112159879 | 11215987 | Injection site bruising | |
| 112159879 | 11215987 | Injection site haematoma | |
| 112159879 | 11215987 | Joint swelling | |
| 112159879 | 11215987 | Malaise | |
| 112159879 | 11215987 | Myalgia | |
| 112159879 | 11215987 | Nasopharyngitis | |
| 112159879 | 11215987 | Pain | |
| 112159879 | 11215987 | Pain in extremity | |
| 112159879 | 11215987 | Peripheral swelling | |
| 112159879 | 11215987 | Rales | |
| 112159879 | 11215987 | Swelling face | |
| 112159879 | 11215987 | Urticaria | |
| 112159879 | 11215987 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 112159879 | 11215987 | 1 | 20130730 | 0 | ||
| 112159879 | 11215987 | 2 | 20130812 | 0 | ||
| 112159879 | 11215987 | 3 | 20140506 | 0 | ||
| 112159879 | 11215987 | 4 | 20140603 | 0 | ||
| 112159879 | 11215987 | 5 | 20150609 | 0 | ||
| 112159879 | 11215987 | 6 | 20150804 | 0 | ||
| 112159879 | 11215987 | 7 | 20150818 | 20150818 | 0 | |
| 112159879 | 11215987 | 8 | 20160119 | 0 | ||
| 112159879 | 11215987 | 10 | 20160426 | 0 | ||
| 112159879 | 11215987 | 11 | 20160705 | 0 | ||
| 112159879 | 11215987 | 12 | 20160719 | 0 | ||
| 112159879 | 11215987 | 13 | 20160830 | 0 |