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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125311271 | 12531127 | 1 | I | 20160608 | 20160610 | 20160706 | 20160706 | PER | US-SHIRE-US201607206 | SHIRE | 22.12 | YR | F | Y | 145.00000 | KG | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125311271 | 12531127 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 60 MG, 1X/DAY:QD | 3139684 | 21977 | 60 | MG | CAPSULE | QD | |||||
| 125311271 | 12531127 | 2 | C | OXCARBAZEPINE. | OXCARBAZEPINE | 1 | Oral | 900 MG, 1X/DAY:QD(AT NIGHT0 | 0 | 900 | MG | TABLET | QD | ||||||
| 125311271 | 12531127 | 3 | C | BUPROPION HCL | BUPROPION HYDROCHLORIDE | 1 | Oral | 75 MG, 1X/DAY:QD (DAILY) | 0 | 75 | MG | TABLET | QD | ||||||
| 125311271 | 12531127 | 4 | C | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Oropharingeal | 20 MG, 1X/DAY:QD | 0 | 20 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125311271 | 12531127 | 1 | Attention deficit/hyperactivity disorder |
| 125311271 | 12531127 | 2 | Bipolar disorder |
| 125311271 | 12531127 | 3 | Antidepressant therapy |
| 125311271 | 12531127 | 4 | Psychotic disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125311271 | 12531127 | Disturbance in attention | |
| 125311271 | 12531127 | Drug ineffective | |
| 125311271 | 12531127 | Product quality issue | |
| 125311271 | 12531127 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 125311271 | 12531127 | 1 | 2014 | 0 |