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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125713872 | 12571387 | 2 | F | 2016 | 20160729 | 20160719 | 20160808 | EXP | US-SHIRE-US201608594 | SHIRE | 42.75 | YR | F | Y | 58.96000 | KG | 20160808 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125713872 | 12571387 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 40 MG, 1X/DAY:QD | U | U | 21977 | 40 | MG | CAPSULE | QD | ||||
| 125713872 | 12571387 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 50 MG, UNKNOWN | U | U | 3139682 | 21977 | 50 | MG | CAPSULE | ||||
| 125713872 | 12571387 | 3 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 30 MG, UNKNOWN | U | U | 21977 | 30 | MG | CAPSULE | |||||
| 125713872 | 12571387 | 4 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Oral | 120 MG, 1X/DAY:QD | 0 | 120 | MG | QD | |||||||
| 125713872 | 12571387 | 5 | C | SAPHRIS | ASENAPINE MALEATE | 1 | Oral | 10 MG, 1X/DAY:QD (DISSOLVING TABLET) | 0 | 10 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125713872 | 12571387 | 1 | Attention deficit/hyperactivity disorder |
| 125713872 | 12571387 | 4 | Product used for unknown indication |
| 125713872 | 12571387 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125713872 | 12571387 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125713872 | 12571387 | Acne cystic | |
| 125713872 | 12571387 | Disability | |
| 125713872 | 12571387 | Drug dose omission | |
| 125713872 | 12571387 | Product quality issue | |
| 125713872 | 12571387 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 125713872 | 12571387 | 1 | 201606 | 20160706 | 0 | |
| 125713872 | 12571387 | 2 | 2016 | 0 | ||
| 125713872 | 12571387 | 3 | 201605 | 201606 | 0 |