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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127777221 | 12777722 | 1 | I | 2015 | 20160915 | 20160924 | 20160924 | PER | US-SHIRE-US201612926 | SHIRE | 6.00 | YR | M | Y | 0.00000 | 20160924 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127777221 | 12777722 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 20 MG, 1X/DAY:QD | 21977 | 20 | MG | CAPSULE | QD | ||||||
| 127777221 | 12777722 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 30 MG, 1X/DAY:QD; REPORTED STARTED DURING SCHOOL YEAR OF 2015 AND STOPPED AFTER SCHOOL ENDED | 21977 | 30 | MG | CAPSULE | QD | ||||||
| 127777221 | 12777722 | 3 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 20 MG, 1X/DAY:QD | 21977 | 20 | MG | CAPSULE | QD | ||||||
| 127777221 | 12777722 | 4 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 30 MG, 1X/DAY:QD | 21977 | 30 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127777221 | 12777722 | 1 | Attention deficit/hyperactivity disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127777221 | 12777722 | Depressed mood | |
| 127777221 | 12777722 | Disturbance in attention | |
| 127777221 | 12777722 | Educational problem | |
| 127777221 | 12777722 | Feeling jittery | |
| 127777221 | 12777722 | Incorrect dose administered | |
| 127777221 | 12777722 | Irritability | |
| 127777221 | 12777722 | 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 |
|---|---|---|---|---|---|---|
| 127777221 | 12777722 | 1 | 201508 | 0 | ||
| 127777221 | 12777722 | 2 | 2015 | 0 | ||
| 127777221 | 12777722 | 3 | 201608 | 201609 | 0 | |
| 127777221 | 12777722 | 4 | 201609 | 0 |