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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126502852 | 12650285 | 2 | F | 201110 | 20160922 | 20160813 | 20160923 | PER | US-SHIRE-US201610273 | SHIRE | 0.00 | F | Y | 0.00000 | 20160923 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126502852 | 12650285 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | UNK UNK, 1X/DAY:QD (HALF OF UNKNOWN CAPSULE CONTENT TO EQUAL 75 MG) | 21977 | CAPSULE | QD | ||||||||
| 126502852 | 12650285 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 40 MG, 1X/DAY:QD | 3139735 | 21977 | 40 | MG | CAPSULE | QD | |||||
| 126502852 | 12650285 | 3 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | UNK UNK, 1X/DAY:QD (OPEN CAPSULE AND TAKES UNKNOWN DOSE 75 %) | 21977 | CAPSULE | QD | ||||||||
| 126502852 | 12650285 | 4 | SS | PROTONIX /00661201/ | OMEPRAZOLE | 1 | Unknown | UNK, UNKNOWN | D | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126502852 | 12650285 | 1 | Attention deficit/hyperactivity disorder |
| 126502852 | 12650285 | 4 | Gastrooesophageal reflux disease |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126502852 | 12650285 | Gastrooesophageal reflux disease | |
| 126502852 | 12650285 | Prescribed overdose | |
| 126502852 | 12650285 | Product quality issue | |
| 126502852 | 12650285 | 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 |
|---|---|---|---|---|---|---|
| 126502852 | 12650285 | 1 | 201110 | 201301 | 0 | |
| 126502852 | 12650285 | 2 | 201301 | 0 | ||
| 126502852 | 12650285 | 3 | 201110 | 0 | ||
| 126502852 | 12650285 | 4 | 2014 | 0 |