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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126785771 | 12678577 | 1 | I | 2013 | 20160819 | 20160823 | 20160823 | EXP | PE-009507513-1608PER011559 | MERCK | 2.00 | YR | F | Y | 0.00000 | 20160823 | CN | PE | PE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126785771 | 12678577 | 1 | PS | SINGULAIR | MONTELUKAST SODIUM | 1 | Oral | 5 MG, QD | Y | N | 20830 | 5 | MG | CHEWABLE TABLET | QD | ||||
| 126785771 | 12678577 | 2 | SS | SINGULAIR | MONTELUKAST SODIUM | 1 | Oral | 5 MG, QD | Y | N | 20830 | 5 | MG | CHEWABLE TABLET | QD | ||||
| 126785771 | 12678577 | 3 | SS | SINGULAIR | MONTELUKAST SODIUM | 1 | Oral | 4 MG, QD AFTER LUNCH | 0 | 4 | MG | GRANULES | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126785771 | 12678577 | 1 | Sinusitis |
| 126785771 | 12678577 | 3 | Rhinitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126785771 | 12678577 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126785771 | 12678577 | Constipation | |
| 126785771 | 12678577 | Cough | |
| 126785771 | 12678577 | Diarrhoea | |
| 126785771 | 12678577 | Drug dose omission | |
| 126785771 | 12678577 | Malaise | |
| 126785771 | 12678577 | Product use issue | |
| 126785771 | 12678577 | Respiratory tract infection | |
| 126785771 | 12678577 | Rhinorrhoea | |
| 126785771 | 12678577 | Sinusitis |
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 |
|---|---|---|---|---|---|---|
| 126785771 | 12678577 | 1 | 201605 | 2016 | 0 | |
| 126785771 | 12678577 | 2 | 20160815 | 0 | ||
| 126785771 | 12678577 | 3 | 2013 | 0 |