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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127300551 | 12730055 | 1 | I | 2016 | 20160901 | 20160909 | 20160909 | PER | US-SHIRE-US201612046 | SHIRE | 59.00 | YR | F | Y | 55.33000 | KG | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127300551 | 12730055 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 40 MG, 1X/DAY:QD | 21977 | 40 | MG | CAPSULE | QD | ||||||
| 127300551 | 12730055 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 50 MG, 1X/DAY:QD | 21977 | 50 | MG | CAPSULE | QD | ||||||
| 127300551 | 12730055 | 3 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 40 MG, 1X/DAY:QD | 21977 | 40 | MG | CAPSULE | QD | ||||||
| 127300551 | 12730055 | 4 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 20 MG, UNKNOWN | 21977 | 20 | MG | CAPSULE | |||||||
| 127300551 | 12730055 | 5 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Oral | 100 MG, 1X/DAY:QD | 0 | 100 | MG | TABLET | QD | ||||||
| 127300551 | 12730055 | 6 | C | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | Oral | 150 MG, 1X/DAY:QD | 0 | 150 | MG | TABLET | QD | ||||||
| 127300551 | 12730055 | 7 | C | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | 0 | TABLET | |||||||||||
| 127300551 | 12730055 | 8 | C | LAMICTAL | LAMOTRIGINE | 1 | Oral | 100 MG, 1X/DAY:QD | 0 | 100 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127300551 | 12730055 | 1 | Attention deficit/hyperactivity disorder |
| 127300551 | 12730055 | 5 | Major depression |
| 127300551 | 12730055 | 6 | Bipolar disorder |
| 127300551 | 12730055 | 7 | Major depression |
| 127300551 | 12730055 | 8 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127300551 | 12730055 | Apathy | |
| 127300551 | 12730055 | Disturbance in attention | |
| 127300551 | 12730055 | Drug dose omission | |
| 127300551 | 12730055 | Drug effect decreased | |
| 127300551 | 12730055 | Hypertension | |
| 127300551 | 12730055 | 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 |
|---|---|---|---|---|---|---|
| 127300551 | 12730055 | 1 | 2014 | 201509 | 0 | |
| 127300551 | 12730055 | 2 | 201509 | 20150928 | 0 | |
| 127300551 | 12730055 | 3 | 20150929 | 0 | ||
| 127300551 | 12730055 | 4 | 2014 | 2014 | 0 |