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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
123436483 | 12343648 | 3 | F | 20160503 | 20160613 | 20160506 | 20160708 | PER | US-SHIRE-US201605603 | SHIRE | 9.01 | YR | M | Y | 26.30000 | KG | 20160708 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
123436483 | 12343648 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 20 MG, UNKNOWN | Y | 3139664 | 21977 | 20 | MG | CAPSULE |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
123436483 | 12343648 | 1 | Product used for unknown indication |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
123436483 | 12343648 | Disturbance in social behaviour | |
123436483 | 12343648 | Irritability | |
123436483 | 12343648 | Product quality issue |
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 |
---|---|---|---|---|---|---|
123436483 | 12343648 | 1 | 20160323 | 20160511 | 0 |