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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127376012 | 12737601 | 2 | F | 2016 | 20160912 | 20160912 | 20160921 | EXP | US-SHIRE-US201611584 | SHIRE | 37.15 | YR | M | Y | 0.00000 | 20160921 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127376012 | 12737601 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 30 MG, 1X/DAY:QD (QAM) | Y | 21977 | 30 | MG | CAPSULE | QD | |||||
| 127376012 | 12737601 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 50 MG, UNKNOWN | Y | 21977 | 50 | MG | CAPSULE | ||||||
| 127376012 | 12737601 | 3 | C | PROPRANOLOL HCL | PROPRANOLOL HYDROCHLORIDE | 1 | Unknown | 20 MG, AS REQ'D | D | 0 | 20 | MG | |||||||
| 127376012 | 12737601 | 4 | C | PROPRANOLOL HCL | PROPRANOLOL HYDROCHLORIDE | 1 | D | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127376012 | 12737601 | 1 | Attention deficit/hyperactivity disorder |
| 127376012 | 12737601 | 3 | Phobia |
| 127376012 | 12737601 | 4 | Anxiety |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127376012 | 12737601 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127376012 | 12737601 | Angina pectoris | |
| 127376012 | 12737601 | Anxiety | |
| 127376012 | 12737601 | Arrhythmia | |
| 127376012 | 12737601 | Cardiac flutter | |
| 127376012 | 12737601 | Decreased appetite | |
| 127376012 | 12737601 | Heart rate irregular | |
| 127376012 | 12737601 | 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 |
|---|---|---|---|---|---|---|
| 127376012 | 12737601 | 1 | 20160731 | 20160820 | 0 | |
| 127376012 | 12737601 | 2 | 20160601 | 0 | ||
| 127376012 | 12737601 | 3 | 20160601 | 0 |