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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122889835 | 12288983 | 5 | F | 20130730 | 20160907 | 20160421 | 20160915 | EXP | CA-ROCHE-1743664 | ROCHE | 39.61 | YR | M | Y | 0.00000 | 20160916 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122889835 | 12288983 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 150 MG, EVERY 3 WEEKS | U | S0060,S0065E,S0001E,S0066B,S0068D | 103976 | 150 | MG | SOLUTION FOR INJECTION | Q3W | ||||
| 122889835 | 12288983 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060,S0065E,S0001E,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | Q3W | |||||||
| 122889835 | 12288983 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060,S0065E,S0001E,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | Q3W | ||||||
| 122889835 | 12288983 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060,S0065E,S0001E,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | Q3W | ||||||
| 122889835 | 12288983 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060,S0065E,S0001E,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | Q3W | ||||||
| 122889835 | 12288983 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060,S0065E,S0001E,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | Q3W | ||||||
| 122889835 | 12288983 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060,S0065E,S0001E,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | Q3W | ||||||
| 122889835 | 12288983 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060,S0065E,S0001E,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | Q3W | ||||||
| 122889835 | 12288983 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060,S0065E,S0001E,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | Q3W | ||||||
| 122889835 | 12288983 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060,S0065E,S0001E,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | Q3W | ||||||
| 122889835 | 12288983 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060,S0065E,S0001E,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | Q3W | ||||||
| 122889835 | 12288983 | 12 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060,S0065E,S0001E,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | Q3W | ||||||
| 122889835 | 12288983 | 13 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060,S0065E,S0001E,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | Q3W | ||||||
| 122889835 | 12288983 | 14 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060,S0065E,S0001E,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | Q3W | ||||||
| 122889835 | 12288983 | 15 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060,S0065E,S0001E,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | Q3W | ||||||
| 122889835 | 12288983 | 16 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 150 MG, BIW (EVERY 2 WEEKS) | U | S0060,S0065E,S0001E,S0066B,S0068D | 103976 | 150 | MG | SOLUTION FOR INJECTION | QOW | ||||
| 122889835 | 12288983 | 17 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060,S0065E,S0001E,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 122889835 | 12288983 | 18 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | S0060,S0065E,S0001E,S0066B,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||||
| 122889835 | 12288983 | 19 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122889835 | 12288983 | 1 | Asthma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122889835 | 12288983 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122889835 | 12288983 | Asthma | |
| 122889835 | 12288983 | Blood pressure increased | |
| 122889835 | 12288983 | Candida infection | |
| 122889835 | 12288983 | Chest pain | |
| 122889835 | 12288983 | Cough | |
| 122889835 | 12288983 | Dizziness | |
| 122889835 | 12288983 | Dyspnoea | |
| 122889835 | 12288983 | Hypertension | |
| 122889835 | 12288983 | Lower respiratory tract congestion | |
| 122889835 | 12288983 | Lower respiratory tract infection | |
| 122889835 | 12288983 | Nasopharyngitis | |
| 122889835 | 12288983 | Paraesthesia oral | |
| 122889835 | 12288983 | Pharyngeal oedema | |
| 122889835 | 12288983 | Respiratory disorder | |
| 122889835 | 12288983 | Sensation of foreign body | |
| 122889835 | 12288983 | 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 |
|---|---|---|---|---|---|---|
| 122889835 | 12288983 | 1 | 20130730 | 0 | ||
| 122889835 | 12288983 | 2 | 20130926 | 0 | ||
| 122889835 | 12288983 | 3 | 20140212 | 0 | ||
| 122889835 | 12288983 | 4 | 20140312 | 0 | ||
| 122889835 | 12288983 | 5 | 20140507 | 0 | ||
| 122889835 | 12288983 | 6 | 20140603 | 0 | ||
| 122889835 | 12288983 | 7 | 20140801 | 0 | ||
| 122889835 | 12288983 | 8 | 20140829 | 0 | ||
| 122889835 | 12288983 | 9 | 20150114 | 0 | ||
| 122889835 | 12288983 | 10 | 20160118 | 0 | ||
| 122889835 | 12288983 | 11 | 20160210 | 0 | ||
| 122889835 | 12288983 | 12 | 20160411 | 0 | ||
| 122889835 | 12288983 | 13 | 20160504 | 0 | ||
| 122889835 | 12288983 | 14 | 20160526 | 0 | ||
| 122889835 | 12288983 | 15 | 20160613 | 20160727 | 0 | |
| 122889835 | 12288983 | 16 | 20160809 | 0 | ||
| 122889835 | 12288983 | 17 | 20160825 | 0 | ||
| 122889835 | 12288983 | 18 | 20160907 | 0 |