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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112337728 | 11233772 | 8 | F | 20120128 | 20160902 | 20150702 | 20160909 | EXP | CA-ROCHE-1602529 | ROCHE | 70.35 | YR | M | Y | 0.00000 | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112337728 | 11233772 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 375 MG, BIW | U | S0003B | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | ||||
| 112337728 | 11233772 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0003B | 103976 | SOLUTION FOR INJECTION | |||||||
| 112337728 | 11233772 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0003B | 103976 | SOLUTION FOR INJECTION | |||||||
| 112337728 | 11233772 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0003B | 103976 | SOLUTION FOR INJECTION | |||||||
| 112337728 | 11233772 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0003B | 103976 | SOLUTION FOR INJECTION | |||||||
| 112337728 | 11233772 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0003B | 103976 | SOLUTION FOR INJECTION | |||||||
| 112337728 | 11233772 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0003B | 103976 | SOLUTION FOR INJECTION | |||||||
| 112337728 | 11233772 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0003B | 103976 | SOLUTION FOR INJECTION | |||||||
| 112337728 | 11233772 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0003B | 103976 | SOLUTION FOR INJECTION | |||||||
| 112337728 | 11233772 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0003B | 103976 | SOLUTION FOR INJECTION | |||||||
| 112337728 | 11233772 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0003B | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | ||||
| 112337728 | 11233772 | 12 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 225 MG, BIW | U | S0003B | 103976 | 225 | MG | SOLUTION FOR INJECTION | QOW | ||||
| 112337728 | 11233772 | 13 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0003B | 103976 | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112337728 | 11233772 | 1 | Asthma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112337728 | 11233772 | HO |
| 112337728 | 11233772 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112337728 | 11233772 | Body temperature decreased | |
| 112337728 | 11233772 | Body temperature increased | |
| 112337728 | 11233772 | Cataract | |
| 112337728 | 11233772 | Cough | |
| 112337728 | 11233772 | Dyspnoea | |
| 112337728 | 11233772 | Fall | |
| 112337728 | 11233772 | Fatigue | |
| 112337728 | 11233772 | Forced expiratory volume decreased | |
| 112337728 | 11233772 | Hyperhidrosis | |
| 112337728 | 11233772 | Hypoventilation | |
| 112337728 | 11233772 | Limb injury | |
| 112337728 | 11233772 | Lung infection | |
| 112337728 | 11233772 | Malaise | |
| 112337728 | 11233772 | Musculoskeletal chest pain | |
| 112337728 | 11233772 | Sneezing | |
| 112337728 | 11233772 | Stress | |
| 112337728 | 11233772 | Throat irritation | |
| 112337728 | 11233772 | Total lung capacity decreased | |
| 112337728 | 11233772 | Tremor | |
| 112337728 | 11233772 | 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 |
|---|---|---|---|---|---|---|
| 112337728 | 11233772 | 1 | 20060427 | 0 | ||
| 112337728 | 11233772 | 2 | 20120725 | 0 | ||
| 112337728 | 11233772 | 3 | 20130829 | 0 | ||
| 112337728 | 11233772 | 4 | 20131003 | 0 | ||
| 112337728 | 11233772 | 5 | 20131114 | 0 | ||
| 112337728 | 11233772 | 6 | 20131121 | 0 | ||
| 112337728 | 11233772 | 7 | 20131211 | 0 | ||
| 112337728 | 11233772 | 8 | 20150316 | 0 | ||
| 112337728 | 11233772 | 9 | 20150827 | 0 | ||
| 112337728 | 11233772 | 10 | 20150914 | 0 | ||
| 112337728 | 11233772 | 11 | 20160623 | 20160623 | 0 | |
| 112337728 | 11233772 | 12 | 20160705 | 0 | ||
| 112337728 | 11233772 | 13 | 20160818 | 0 |