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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 95361103 | 9536110 | 3 | F | 20120229 | 20160726 | 20130919 | 20160729 | EXP | CA-009507513-1309CAN006063 | MERCK | 7.00 | YR | M | Y | 32.00000 | KG | 20160729 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 95361103 | 9536110 | 1 | PS | SINGULAIR | MONTELUKAST SODIUM | 1 | Oral | 1 TABLET AT NIGHT | N | 313222 | 20830 | 5 | MG | CHEWABLE TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 95361103 | 9536110 | 1 | Asthma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 95361103 | 9536110 | LT |
| 95361103 | 9536110 | DS |
| 95361103 | 9536110 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 95361103 | 9536110 | Aggression | |
| 95361103 | 9536110 | Agitation | |
| 95361103 | 9536110 | Depressed mood | |
| 95361103 | 9536110 | Disturbance in attention | |
| 95361103 | 9536110 | Fatigue | |
| 95361103 | 9536110 | Fear | |
| 95361103 | 9536110 | Frustration tolerance decreased | |
| 95361103 | 9536110 | Irritability | |
| 95361103 | 9536110 | Negative thoughts | |
| 95361103 | 9536110 | Pyrexia | |
| 95361103 | 9536110 | Rash | |
| 95361103 | 9536110 | Sleep disorder |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |