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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116803533 | 11680353 | 3 | F | 20151019 | 20160721 | 20151029 | 20160726 | EXP | CA-ROCHE-1651461 | ROCHE | 46.65 | YR | F | Y | 0.00000 | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116803533 | 11680353 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, BIW | U | S0066B | 103976 | 300 | MG | SOLUTION FOR INJECTION | QOW | ||||
| 116803533 | 11680353 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0066B | 103976 | SOLUTION FOR INJECTION | |||||||
| 116803533 | 11680353 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0066B | 103976 | SOLUTION FOR INJECTION | |||||||
| 116803533 | 11680353 | 4 | SS | ONBREZ BREEZHALER | INDACATEROL | 1 | Respiratory (inhalation) | UNK | U | 0 | |||||||||
| 116803533 | 11680353 | 5 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 116803533 | 11680353 | 6 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 116803533 | 11680353 | 7 | C | DEXILANT | DEXLANSOPRAZOLE | 1 | Unknown | UNK | U | 0 | |||||||||
| 116803533 | 11680353 | 8 | C | CANDESARTAN | CANDESARTAN | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116803533 | 11680353 | 1 | Asthma |
| 116803533 | 11680353 | 4 | Product used for unknown indication |
| 116803533 | 11680353 | 5 | Product used for unknown indication |
| 116803533 | 11680353 | 6 | Product used for unknown indication |
| 116803533 | 11680353 | 7 | Product used for unknown indication |
| 116803533 | 11680353 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116803533 | 11680353 | HO |
| 116803533 | 11680353 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116803533 | 11680353 | Altered state of consciousness | |
| 116803533 | 11680353 | Back pain | |
| 116803533 | 11680353 | Blood pressure increased | |
| 116803533 | 11680353 | Cough | |
| 116803533 | 11680353 | Dizziness | |
| 116803533 | 11680353 | Dysphonia | |
| 116803533 | 11680353 | Dyspnoea | |
| 116803533 | 11680353 | Headache | |
| 116803533 | 11680353 | Pallor | |
| 116803533 | 11680353 | Sneezing | |
| 116803533 | 11680353 | Vision blurred | |
| 116803533 | 11680353 | 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 |
|---|---|---|---|---|---|---|
| 116803533 | 11680353 | 1 | 20151019 | 0 | ||
| 116803533 | 11680353 | 2 | 20160707 | 0 | ||
| 116803533 | 11680353 | 3 | 20160721 | 0 |