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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125088742 | 12508874 | 2 | F | 201510 | 20160714 | 20160629 | 20160719 | PER | US-SHIRE-US201606904 | SHIRE | 33.75 | YR | M | Y | 88.44000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125088742 | 12508874 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 30 MG, 1X/DAY:QD | 21977 | 30 | MG | CAPSULE | QD | ||||||
| 125088742 | 12508874 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | UNK(OPENS 30 MG CAPSULE TAKES UNKNOWN MG FROM HALF OF CONTENTS AT 8 AM AND AT 2PM), 2X/DAY:BID | 21977 | CAPSULE | BID | ||||||||
| 125088742 | 12508874 | 3 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | UNK (OPENS 50 MG CAPSULE TAKES UNKNOWN MG FROM HALF OF THE CONTENTS AT 8 AM AND AT 2 PM),2X/DAY: | AE6263B | 21977 | CAPSULE | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125088742 | 12508874 | 1 | Attention deficit/hyperactivity disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125088742 | 12508874 | Anxiety | |
| 125088742 | 12508874 | Drug effect decreased | |
| 125088742 | 12508874 | Drug effect increased | |
| 125088742 | 12508874 | Inappropriate schedule of drug administration | |
| 125088742 | 12508874 | Incorrect dose administered | |
| 125088742 | 12508874 | 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 |
|---|---|---|---|---|---|---|
| 125088742 | 12508874 | 1 | 201509 | 201510 | 0 | |
| 125088742 | 12508874 | 2 | 201510 | 201605 | 0 | |
| 125088742 | 12508874 | 3 | 20160601 | 0 |