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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120722823 | 12072282 | 3 | F | 2014 | 20160713 | 20160212 | 20160719 | EXP | PHHY2015CA143204 | NOVARTIS | 0.00 | F | Y | 0.00000 | 20160719 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120722823 | 12072282 | 1 | PS | NEORAL | CYCLOSPORINE | 1 | Oral | 100 MG, QD | U | 50715 | 100 | MG | QD | ||||||
| 120722823 | 12072282 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, Q 4 WEEKS | U | 0 | 300 | MG | VIAL | ||||||
| 120722823 | 12072282 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0002F | 0 | VIAL |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120722823 | 12072282 | 1 | Chronic spontaneous urticaria |
| 120722823 | 12072282 | 2 | Chronic spontaneous urticaria |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120722823 | 12072282 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120722823 | 12072282 | Drug effect incomplete | |
| 120722823 | 12072282 | Dyspnoea | |
| 120722823 | 12072282 | Erythema | |
| 120722823 | 12072282 | Headache | |
| 120722823 | 12072282 | Injury | |
| 120722823 | 12072282 | Migraine | |
| 120722823 | 12072282 | Nasopharyngitis | |
| 120722823 | 12072282 | Pain in extremity | |
| 120722823 | 12072282 | Pericardial effusion | |
| 120722823 | 12072282 | Pericarditis | |
| 120722823 | 12072282 | Product use issue | |
| 120722823 | 12072282 | Pruritus | |
| 120722823 | 12072282 | Skin swelling | |
| 120722823 | 12072282 | Sleep disorder due to general medical condition, insomnia type | |
| 120722823 | 12072282 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 120722823 | 12072282 | 1 | 2013 | 0 | ||
| 120722823 | 12072282 | 2 | 20160208 | 0 | ||
| 120722823 | 12072282 | 3 | 20160602 | 0 |