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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117663274 | 11766327 | 4 | F | 20150409 | 20160720 | 20151123 | 20160726 | EXP | CA-ROCHE-1662335 | ROCHE | 18.97 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117663274 | 11766327 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 375 MG, BIW | U | S0065E | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | ||||
| 117663274 | 11766327 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 117663274 | 11766327 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 117663274 | 11766327 | 4 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 8 DAY COURSE | 0 | 30 | MG | ||||||||
| 117663274 | 11766327 | 5 | C | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | Unknown | 5 DAYS | 0 | 250 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117663274 | 11766327 | 1 | Asthma |
| 117663274 | 11766327 | 4 | Dyspnoea |
| 117663274 | 11766327 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117663274 | 11766327 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117663274 | 11766327 | Cough | |
| 117663274 | 11766327 | Dyspnoea | |
| 117663274 | 11766327 | Ear pain | |
| 117663274 | 11766327 | Lower respiratory tract congestion | |
| 117663274 | 11766327 | Nasal congestion | |
| 117663274 | 11766327 | Oropharyngeal pain | |
| 117663274 | 11766327 | Pulmonary function test decreased | |
| 117663274 | 11766327 | Sinus congestion | |
| 117663274 | 11766327 | 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 |
|---|---|---|---|---|---|---|
| 117663274 | 11766327 | 1 | 20130722 | 0 | ||
| 117663274 | 11766327 | 2 | 20160329 | 0 | ||
| 117663274 | 11766327 | 3 | 20160707 | 20160707 | 0 | |
| 117663274 | 11766327 | 4 | 20160324 | 0 |