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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125275441 | 12527544 | 1 | I | 2016 | 20160607 | 20160705 | 20160705 | PER | US-SHIRE-US201607046 | SHIRE | 54.57 | YR | F | Y | 0.00000 | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125275441 | 12527544 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 50 MG, 1X/DAY:QD | 21977 | 50 | MG | CAPSULE | QD | ||||||
| 125275441 | 12527544 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | 21977 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125275441 | 12527544 | 1 | Somnolence |
| 125275441 | 12527544 | 2 | Performance status decreased |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125275441 | 12527544 | Drug effect decreased | |
| 125275441 | 12527544 | Drug ineffective | |
| 125275441 | 12527544 | Product quality issue | |
| 125275441 | 12527544 | Product use 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 |
|---|---|---|---|---|---|---|
| 125275441 | 12527544 | 1 | 20160402 | 0 |