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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112046105 | 11204610 | 5 | F | 201505 | 20160829 | 20150622 | 20160902 | EXP | CA-ROCHE-1596807 | ROCHE | 35.55 | YR | F | Y | 103.60000 | KG | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112046105 | 11204610 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | S0062 | 103976 | 225 | MG | SOLUTION FOR INJECTION | QOW | ||||||
| 112046105 | 11204610 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | S0062 | 103976 | ||||||||||
| 112046105 | 11204610 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | S0062 | 103976 | ||||||||||
| 112046105 | 11204610 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | S0062 | 103976 | 225 | MG | BID | |||||||
| 112046105 | 11204610 | 5 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | 0 | ||||||||||||
| 112046105 | 11204610 | 6 | C | FLOVENT | FLUTICASONE PROPIONATE | 1 | 0 | ||||||||||||
| 112046105 | 11204610 | 7 | C | PREDNISONE. | PREDNISONE | 1 | 0 | ||||||||||||
| 112046105 | 11204610 | 8 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | 0 | ||||||||||||
| 112046105 | 11204610 | 9 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112046105 | 11204610 | 1 | Asthma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112046105 | 11204610 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112046105 | 11204610 | Anaphylactic shock | |
| 112046105 | 11204610 | Anxiety | |
| 112046105 | 11204610 | Bronchitis | |
| 112046105 | 11204610 | Dyspnoea | |
| 112046105 | 11204610 | Hypersensitivity | |
| 112046105 | 11204610 | Middle insomnia | |
| 112046105 | 11204610 | Pneumonia | |
| 112046105 | 11204610 | 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 |
|---|---|---|---|---|---|---|
| 112046105 | 11204610 | 1 | 20120116 | 0 | ||
| 112046105 | 11204610 | 2 | 20160322 | 0 | ||
| 112046105 | 11204610 | 3 | 20160405 | 0 | ||
| 112046105 | 11204610 | 4 | 20160419 | 20160419 | 0 |