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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126194431 | 12619443 | 1 | I | 201603 | 20160714 | 20160803 | 20160803 | PER | US-SHIRE-US201608852 | SHIRE | 8.95 | YR | F | Y | 0.00000 | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126194431 | 12619443 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 20 MG, 1X/DAY:QD (5 AM DAILY) | Y | 21977 | 20 | MG | CAPSULE | QD | |||||
| 126194431 | 12619443 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | UNK (HALF CONTENTS OF 20 MG CAPSULE), 1X/DAY:QD | Y | 21977 | CAPSULE | QD | |||||||
| 126194431 | 12619443 | 3 | C | INTUNIV | GUANFACINE HYDROCHLORIDE | 1 | Oral | 2 MG, 1X/DAY:QD | 0 | 2 | MG | TABLET | QD | ||||||
| 126194431 | 12619443 | 4 | C | CLONIDINE. | CLONIDINE | 1 | Oral | 0.1 MG, 1X/DAY:QD | 0 | .1 | MG | TABLET | QD | ||||||
| 126194431 | 12619443 | 5 | C | MELATONIN | MELATONIN | 1 | Oral | 2.5 - 10 MG, AS REQ'D | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126194431 | 12619443 | 1 | Attention deficit/hyperactivity disorder |
| 126194431 | 12619443 | 2 | Somnolence |
| 126194431 | 12619443 | 3 | Aggression |
| 126194431 | 12619443 | 4 | Aggression |
| 126194431 | 12619443 | 5 | Sleep disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126194431 | 12619443 | Drug effect increased | |
| 126194431 | 12619443 | Incorrect dose administered | |
| 126194431 | 12619443 | Insomnia |
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 |
|---|---|---|---|---|---|---|
| 126194431 | 12619443 | 1 | 201603 | 201604 | 0 | |
| 126194431 | 12619443 | 2 | 201604 | 201604 | 0 | |
| 126194431 | 12619443 | 3 | 2014 | 0 | ||
| 126194431 | 12619443 | 4 | 201503 | 0 |