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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117451868 | 11745186 | 8 | F | 20150825 | 20160630 | 20151117 | 20160712 | EXP | CA-ROCHE-1661132 | ROCHE | 12.74 | YR | F | Y | 0.00000 | 20160712 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117451868 | 11745186 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, BIW (EVERY 2 WEEKS) | S0060,S0062,S0066B | 103976 | 300 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 117451868 | 11745186 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | S0060,S0062,S0066B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 117451868 | 11745186 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | S0060,S0062,S0066B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 117451868 | 11745186 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | S0060,S0062,S0066B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 117451868 | 11745186 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | S0060,S0062,S0066B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 117451868 | 11745186 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | S0060,S0062,S0066B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 117451868 | 11745186 | 7 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 117451868 | 11745186 | 8 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117451868 | 11745186 | 1 | Asthma |
| 117451868 | 11745186 | 7 | Product used for unknown indication |
| 117451868 | 11745186 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117451868 | 11745186 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117451868 | 11745186 | Allergy to animal | |
| 117451868 | 11745186 | Arthralgia | |
| 117451868 | 11745186 | Asthenia | |
| 117451868 | 11745186 | Asthma | |
| 117451868 | 11745186 | Decreased appetite | |
| 117451868 | 11745186 | Dehydration | |
| 117451868 | 11745186 | Discomfort | |
| 117451868 | 11745186 | Dizziness | |
| 117451868 | 11745186 | Dyspnoea | |
| 117451868 | 11745186 | Dyspnoea exertional | |
| 117451868 | 11745186 | Erythema | |
| 117451868 | 11745186 | Eye pruritus | |
| 117451868 | 11745186 | Fatigue | |
| 117451868 | 11745186 | Gastroenteritis | |
| 117451868 | 11745186 | Heart rate increased | |
| 117451868 | 11745186 | Hydronephrosis | |
| 117451868 | 11745186 | Hypersensitivity | |
| 117451868 | 11745186 | Hypersomnia | |
| 117451868 | 11745186 | Injection site pain | |
| 117451868 | 11745186 | Malaise | |
| 117451868 | 11745186 | Myalgia | |
| 117451868 | 11745186 | Nasopharyngitis | |
| 117451868 | 11745186 | Pyrexia | |
| 117451868 | 11745186 | Respiratory tract congestion |
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 |
|---|---|---|---|---|---|---|
| 117451868 | 11745186 | 1 | 20150811 | 0 | ||
| 117451868 | 11745186 | 2 | 20151021 | 0 | ||
| 117451868 | 11745186 | 3 | 20160310 | 0 | ||
| 117451868 | 11745186 | 4 | 20160421 | 0 | ||
| 117451868 | 11745186 | 5 | 20160505 | 0 | ||
| 117451868 | 11745186 | 6 | 20160602 | 20160602 | 0 |