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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126230533 | 12623053 | 3 | F | 2016 | 20160809 | 20160804 | 20160819 | EXP | JP-UCBSA-2016028747 | UCB | 0.00 | Y | 0.00000 | 20160819 | PH | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126230533 | 12623053 | 1 | PS | XYZAL | LEVOCETIRIZINE DIHYDROCHLORIDE | 1 | Oral | 5 MG, QD | Y | U | 22064 | 5 | MG | FILM-COATED TABLET | QD | ||||
| 126230533 | 12623053 | 2 | SS | SINGULAIR | MONTELUKAST SODIUM | 1 | Oral | UNK | Y | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126230533 | 12623053 | 1 | Rhinitis allergic |
| 126230533 | 12623053 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126230533 | 12623053 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126230533 | 12623053 | Haematuria | |
| 126230533 | 12623053 | Nephrolithiasis | |
| 126230533 | 12623053 | Pain |
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 |
|---|---|---|---|---|---|---|
| 126230533 | 12623053 | 1 | 20160331 | 201605 | 0 | |
| 126230533 | 12623053 | 2 | 20160413 | 2016 | 0 |