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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125041972 | 12504197 | 2 | F | 201605 | 20160714 | 20160628 | 20160719 | PER | US-SHIRE-US201606809 | SHIRE | 6.00 | YR | M | Y | 0.00000 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125041972 | 12504197 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 20 MG, 1X/DAY:QD | 3142761 | 21977 | 20 | MG | CAPSULE | QD |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125041972 | 12504197 | 1 | Attention deficit/hyperactivity disorder |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125041972 | 12504197 | Drug ineffective | |
125041972 | 12504197 | Personality change | |
125041972 | 12504197 | Product quality issue |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |