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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125519251 | 12551925 | 1 | I | 201604 | 20160707 | 20160713 | 20160713 | PER | US-SHIRE-US201608599 | SHIRE | 4.00 | YR | M | Y | 16.33000 | KG | 20160713 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125519251 | 12551925 | 1 | PS | INTUNIV | GUANFACINE HYDROCHLORIDE | 1 | Oral | 1 MG, 1X/DAY:QD | 22037 | 1 | MG | TABLET | QD | ||||||
| 125519251 | 12551925 | 2 | SS | INTUNIV | GUANFACINE HYDROCHLORIDE | 1 | Oral | 3 MG, 1X/DAY:QD | 22037 | 3 | MG | TABLET | QD | ||||||
| 125519251 | 12551925 | 3 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | UNK, UNKNOWN | U | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125519251 | 12551925 | 1 | Attention deficit/hyperactivity disorder |
| 125519251 | 12551925 | 3 | Attention deficit/hyperactivity disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125519251 | 12551925 | Drug titration error | |
| 125519251 | 12551925 | No adverse event | |
| 125519251 | 12551925 | 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 |
|---|---|---|---|---|---|---|
| 125519251 | 12551925 | 1 | 201604 | 201607 | 0 | |
| 125519251 | 12551925 | 2 | 201607 | 0 |