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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126601131 | 12660113 | 1 | I | 2015 | 20160805 | 20160817 | 20160817 | PER | US-SHIRE-US201610195 | SHIRE | 52.99 | YR | M | Y | 108.84000 | KG | 20160817 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126601131 | 12660113 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 30 MG, 2X/DAY:BID | 21977 | 30 | MG | CAPSULE | BID | ||||||
| 126601131 | 12660113 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | HALF 60 MG, 2X/DAY:BID (HALF 60 MG CAPSULE IN THE MORNING AND HALF IN THE AFTERNOON) | 3140601 | 21977 | CAPSULE | BID | |||||||
| 126601131 | 12660113 | 3 | C | ALLEGRA-D | FEXOFENADINEPSEUDOEPHEDRINE | 1 | Oral | 1 DF, 1X/2WKS | 0 | 1 | DF | TABLET | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126601131 | 12660113 | 1 | Attention deficit/hyperactivity disorder |
| 126601131 | 12660113 | 3 | Sinusitis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126601131 | 12660113 | Abdominal pain upper | |
| 126601131 | 12660113 | Diarrhoea | |
| 126601131 | 12660113 | Drug ineffective | |
| 126601131 | 12660113 | Inappropriate schedule of drug administration | |
| 126601131 | 12660113 | Incorrect dose administered | |
| 126601131 | 12660113 | Malaise | |
| 126601131 | 12660113 | Product quality issue | |
| 126601131 | 12660113 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 126601131 | 12660113 | 1 | 201507 | 2015 | 0 | |
| 126601131 | 12660113 | 2 | 2015 | 0 |