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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123309426 | 12330942 | 6 | F | 2015 | 20160712 | 20160504 | 20160720 | EXP | US-SHIRE-US201605418 | SHIRE | 0.00 | M | Y | 17.23000 | KG | 20160720 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123309426 | 12330942 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | UNK, UNKNOWN | 21977 | CAPSULE | |||||||||
| 123309426 | 12330942 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | UNK UNK (HALF 20 MG CAPSULE), 1X/DAY:QD (IN THE AM ON SCHOOL AND NON-SCHOOL DAYS) | N626987 | 21977 | CAPSULE | QD | |||||||
| 123309426 | 12330942 | 3 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 10 MG, 1X/DAY:QD (12 NOON TO 12:30 SCHOOL DAYS) | 21977 | 10 | MG | CAPSULE | QD | ||||||
| 123309426 | 12330942 | 4 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | UNK (REST OF 20 MG HALF CAPSULE), 1X/DAY:QD (AT 12 NOON TO 12:30 ON NON-SCHOOL DAYS) | 21977 | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123309426 | 12330942 | 1 | Attention deficit/hyperactivity disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123309426 | 12330942 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123309426 | 12330942 | Autism | |
| 123309426 | 12330942 | Cough | |
| 123309426 | 12330942 | Disturbance in social behaviour | |
| 123309426 | 12330942 | Drug administered to patient of inappropriate age | |
| 123309426 | 12330942 | Inappropriate schedule of drug administration | |
| 123309426 | 12330942 | Malaise | |
| 123309426 | 12330942 | Nasal congestion | |
| 123309426 | 12330942 | Product quality issue | |
| 123309426 | 12330942 | Pyrexia | |
| 123309426 | 12330942 | 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 |
|---|---|---|---|---|---|---|
| 123309426 | 12330942 | 1 | 2015 | 2015 | 0 | |
| 123309426 | 12330942 | 2 | 2015 | 0 | ||
| 123309426 | 12330942 | 3 | 2015 | 0 | ||
| 123309426 | 12330942 | 4 | 2015 | 0 |