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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126101224 | 12610122 | 4 | F | 2016 | 20160915 | 20160801 | 20160923 | EXP | PHHY2016CA104286 | SANDOZ | 0.00 | F | Y | 0.00000 | 20160923 | CN | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126101224 | 12610122 | 1 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, EVERY 4 WEEKS | U | 0 | 300 | MG | |||||||
126101224 | 12610122 | 2 | PS | CICLOSPORIN | CYCLOSPORINE | 1 | Oral | 100 MG, BID | U | 65017 | 100 | MG | BID | ||||||
126101224 | 12610122 | 3 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | Oral | 150 MG, BID | U | 65017 | 150 | MG | BID | ||||||
126101224 | 12610122 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | UNK (TAPERRED OFF) | 0 | ||||||||||
126101224 | 12610122 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 5 MG, UNK | 0 | 5 | MG | ||||||||
126101224 | 12610122 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 20 MG, UNK | 0 | 20 | MG | ||||||||
126101224 | 12610122 | 7 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | UNK UNK, QD (AT NIGHT) | U | 0 | QD |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
126101224 | 12610122 | 1 | Chronic spontaneous urticaria |
126101224 | 12610122 | 2 | Product used for unknown indication |
126101224 | 12610122 | 4 | Product used for unknown indication |
126101224 | 12610122 | 7 | Product used for unknown indication |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
126101224 | 12610122 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
126101224 | 12610122 | Adrenal insufficiency | |
126101224 | 12610122 | Fatigue | |
126101224 | 12610122 | Somnolence | |
126101224 | 12610122 | 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 |
---|---|---|---|---|---|---|
126101224 | 12610122 | 1 | 20160321 | 0 | ||
126101224 | 12610122 | 2 | 20150615 | 0 | ||
126101224 | 12610122 | 3 | 2015 | 0 |