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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 94349286 | 9434928 | 6 | F | 2008 | 20160623 | 20130801 | 20160706 | EXP | BR-ROCHE-1255550 | ROCHE | 0.00 | F | Y | 62.00000 | KG | 20160706 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 94349286 | 9434928 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | DOSE: 75/100 MG, 12.5 AMPOULES | 103976 | 375 | MG | ||||||||
| 94349286 | 9434928 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | 103976 | ||||||||||
| 94349286 | 9434928 | 3 | SS | FORASEQ | BUDESONIDEFORMOTEROL FUMARATE | 1 | Respiratory (inhalation) | 400/12 MG | 0 | 1 | DF | CAPSULE | BID | ||||||
| 94349286 | 9434928 | 4 | C | ENALAPRIL | ENALAPRIL | 1 | Oral | 1 DF, QD | 0 | 20 | MG | TABLET | QD | ||||||
| 94349286 | 9434928 | 5 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 1 DF, QD | 0 | 25 | UG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 94349286 | 9434928 | 1 | Asthma |
| 94349286 | 9434928 | 3 | Asthma |
| 94349286 | 9434928 | 4 | Blood pressure abnormal |
| 94349286 | 9434928 | 5 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 94349286 | 9434928 | HO |
| 94349286 | 9434928 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 94349286 | 9434928 | Asthma | |
| 94349286 | 9434928 | Back pain | |
| 94349286 | 9434928 | Chronic sinusitis | |
| 94349286 | 9434928 | Condition aggravated | |
| 94349286 | 9434928 | Dyspnoea | |
| 94349286 | 9434928 | Erythema | |
| 94349286 | 9434928 | Fatigue | |
| 94349286 | 9434928 | Hypertension | |
| 94349286 | 9434928 | Hypothyroidism | |
| 94349286 | 9434928 | Malaise | |
| 94349286 | 9434928 | Nasal dryness | |
| 94349286 | 9434928 | Nasal inflammation | |
| 94349286 | 9434928 | Nasal obstruction | |
| 94349286 | 9434928 | Pneumonitis | |
| 94349286 | 9434928 | Syncope | |
| 94349286 | 9434928 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 94349286 | 9434928 | 1 | 20081007 | 0 | ||
| 94349286 | 9434928 | 2 | 20130715 | 0 | ||
| 94349286 | 9434928 | 3 | 2006 | 0 |