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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125954832 | 12595483 | 2 | F | 2011 | 20160730 | 20160726 | 20160803 | PER | US-SHIRE-US201608338 | SHIRE | 41.60 | YR | M | Y | 69.84000 | KG | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125954832 | 12595483 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 70 MG, 1X/DAY:QD | 21977 | 70 | MG | CAPSULE | QD | ||||||
| 125954832 | 12595483 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 50 MG, 1X/DAY:QD | 3140604 | 21977 | 50 | MG | CAPSULE | QD | |||||
| 125954832 | 12595483 | 3 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 30 MG, 1X/DAY:QD | 21977 | 30 | MG | CAPSULE | QD | ||||||
| 125954832 | 12595483 | 4 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 50 MG, 1X/DAY:QD | 21977 | 50 | MG | CAPSULE | QD | ||||||
| 125954832 | 12595483 | 5 | C | XANAX | ALPRAZOLAM | 1 | Oral | 1 MG, 3X/DAY:TID | 0 | 1 | MG | TID | |||||||
| 125954832 | 12595483 | 6 | C | XANAX | ALPRAZOLAM | 1 | Oral | 0.5 MG, 1X/DAY:QD | 0 | .5 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125954832 | 12595483 | 1 | Attention deficit/hyperactivity disorder |
| 125954832 | 12595483 | 5 | Anxiety |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125954832 | 12595483 | Anxiety | |
| 125954832 | 12595483 | Confusional state | |
| 125954832 | 12595483 | Disturbance in attention | |
| 125954832 | 12595483 | Drug effect increased | |
| 125954832 | 12595483 | Drug ineffective | |
| 125954832 | 12595483 | Feeling abnormal | |
| 125954832 | 12595483 | Inappropriate schedule of drug administration | |
| 125954832 | 12595483 | Incorrect dose administered | |
| 125954832 | 12595483 | Product quality issue | |
| 125954832 | 12595483 | Somnolence | |
| 125954832 | 12595483 | Tachyphrenia | |
| 125954832 | 12595483 | 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 |
|---|---|---|---|---|---|---|
| 125954832 | 12595483 | 1 | 2012 | 2012 | 0 | |
| 125954832 | 12595483 | 2 | 2012 | 0 | ||
| 125954832 | 12595483 | 3 | 2010 | 2010 | 0 | |
| 125954832 | 12595483 | 4 | 2010 | 2012 | 0 | |
| 125954832 | 12595483 | 5 | 2014 | 0 | ||
| 125954832 | 12595483 | 6 | 2014 | 0 |