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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124976182 | 12497618 | 2 | F | 201605 | 20160708 | 20160625 | 20160713 | PER | US-SHIRE-US201607219 | SHIRE | 0.00 | F | Y | 61.68000 | KG | 20160709 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124976182 | 12497618 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | UNK, UNKNOWN (OPENS CAPSULE AND TAKES A LITTLE BIT ONCE IN A WHILE) | 3143590 | 21977 | CAPSULE | ||||||||
| 124976182 | 12497618 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 40 MG, 1X/DAY:QD | 3143590 | 21977 | 40 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124976182 | 12497618 | 1 | Attention deficit/hyperactivity disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124976182 | 12497618 | Incorrect dose administered | |
| 124976182 | 12497618 | No adverse event | |
| 124976182 | 12497618 | 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 |
|---|---|---|---|---|---|---|
| 124976182 | 12497618 | 1 | 201605 | 0 | ||
| 124976182 | 12497618 | 2 | 2016 | 0 |