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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124979112 | 12497911 | 2 | F | 20160520 | 20160720 | 20160625 | 20160722 | PER | US-SHIRE-US201606855 | SHIRE | 15.00 | YR | F | Y | 47.62000 | KG | 20160722 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124979112 | 12497911 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 70 MG, 1X/DAY:QD | AF0672B | 21977 | 70 | MG | CAPSULE | QD | |||||
| 124979112 | 12497911 | 2 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | UNK, 1X/DAY:QD | 0 | CAPSULE | QD | ||||||||
| 124979112 | 12497911 | 3 | C | ABILIFY | ARIPIPRAZOLE | 1 | Oral | 10 MG, 1X/DAY:QD (AT NIGHT) | 0 | 10 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124979112 | 12497911 | 1 | Attention deficit/hyperactivity disorder |
| 124979112 | 12497911 | 2 | Attention deficit/hyperactivity disorder |
| 124979112 | 12497911 | 3 | General symptom |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124979112 | 12497911 | Drug effect variable | |
| 124979112 | 12497911 | Drug ineffective | |
| 124979112 | 12497911 | Product quality issue | |
| 124979112 | 12497911 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 124979112 | 12497911 | 1 | 20160519 | 0 | ||
| 124979112 | 12497911 | 2 | 2015 | 0 | ||
| 124979112 | 12497911 | 3 | 2015 | 0 |