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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125541881 | 12554188 | 1 | I | 2016 | 20160629 | 20160713 | 20160713 | EXP | US-SHIRE-US201608202 | SHIRE | 0.00 | F | Y | 70.30000 | KG | 20160713 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125541881 | 12554188 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 70 MG, 1X/DAY:QD | Y | Y | 21977 | 70 | MG | CAPSULE | QD | ||||
| 125541881 | 12554188 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | UNK, 1X/DAY:QD | Y | Y | 21977 | CAPSULE | QD | ||||||
| 125541881 | 12554188 | 3 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 60 MG, 1X/DAY:QD | Y | Y | 21977 | 60 | MG | CAPSULE | QD | ||||
| 125541881 | 12554188 | 4 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 60 MG, 1X/DAY:QD (FOR 10 DAYS) | Y | Y | 21977 | 60 | MG | CAPSULE | QD | ||||
| 125541881 | 12554188 | 5 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 70 MG, 1X/DAY:QD | Y | Y | 21977 | 70 | MG | CAPSULE | QD | ||||
| 125541881 | 12554188 | 6 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Oral | 7 ML (20 MG/ML), 1X/DAY:QD | 0 | 7 | ML | QD | |||||||
| 125541881 | 12554188 | 7 | C | GABAPENTIN. | GABAPENTIN | 1 | Oral | 200 MG, 1X/DAY:QD | 0 | 200 | MG | QD | |||||||
| 125541881 | 12554188 | 8 | C | DEPLIN | LEVOMEFOLATE CALCIUM | 1 | Oral | 15 MG, 1X/DAY:QD | 0 | 15 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125541881 | 12554188 | 1 | Attention deficit/hyperactivity disorder |
| 125541881 | 12554188 | 6 | Depression |
| 125541881 | 12554188 | 7 | Sleep disorder |
| 125541881 | 12554188 | 8 | Depression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125541881 | 12554188 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125541881 | 12554188 | Arthralgia | |
| 125541881 | 12554188 | Incorrect dose administered | |
| 125541881 | 12554188 | Inflammation | |
| 125541881 | 12554188 | Polyarthritis | |
| 125541881 | 12554188 | Product quality 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 |
|---|---|---|---|---|---|---|
| 125541881 | 12554188 | 1 | 201512 | 2016 | 0 | |
| 125541881 | 12554188 | 4 | 2016 | 2016 | 0 | |
| 125541881 | 12554188 | 5 | 2016 | 0 | ||
| 125541881 | 12554188 | 7 | 2011 | 0 | ||
| 125541881 | 12554188 | 8 | 2015 | 0 |