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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124596932 | 12459693 | 2 | F | 201504 | 20160714 | 20160613 | 20160719 | PER | US-SHIRE-US201606555 | SHIRE | 47.43 | YR | F | Y | 55.78000 | KG | 20160719 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124596932 | 12459693 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 20 MG, 1X/DAY:QD | 21977 | 20 | MG | CAPSULE | QD | ||||||
| 124596932 | 12459693 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 30 MG, 1X/DAY:QD | 3139719 | 21977 | 30 | MG | CAPSULE | QD | |||||
| 124596932 | 12459693 | 3 | C | CREON | PANCRELIPASE AMYLASEPANCRELIPASE LIPASEPANCRELIPASE PROTEASE | 1 | Oral | 24000 IU, AS REQ'D | 0 | 24000 | IU | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124596932 | 12459693 | 1 | Attention deficit/hyperactivity disorder |
| 124596932 | 12459693 | 3 | Dyspepsia |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124596932 | 12459693 | Drug effect decreased | |
| 124596932 | 12459693 | Drug ineffective | |
| 124596932 | 12459693 | Palpitations |
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 |
|---|---|---|---|---|---|---|
| 124596932 | 12459693 | 1 | 201504 | 201508 | 0 | |
| 124596932 | 12459693 | 2 | 201508 | 0 | ||
| 124596932 | 12459693 | 3 | 2012 | 0 |