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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127611132 | 12761113 | 2 | F | 2012 | 20160913 | 20160920 | 20160922 | EXP | PT-ROCHE-1830465 | ROCHE | 0.00 | F | Y | 0.00000 | 20160922 | MD | PT | PT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127611132 | 12761113 | 1 | PS | Omalizumab | OMALIZUMAB | 1 | Unknown | 300 MG, EVERY 8 WEEKS | U | 103976 | 300 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127611132 | 12761113 | 1 | Chronic spontaneous urticaria |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127611132 | 12761113 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127611132 | 12761113 | Dyspnoea | |
| 127611132 | 12761113 | Inappropriate schedule of drug administration | |
| 127611132 | 12761113 | Pruritus | |
| 127611132 | 12761113 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 127611132 | 12761113 | 1 | 2012 | 0 |