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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123966115 | 12396611 | 5 | F | 20160201 | 20160809 | 20160524 | 20160817 | EXP | US-SHIRE-US201605933 | SHIRE | 12.94 | YR | M | Y | 66.98000 | KG | 20160817 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123966115 | 12396611 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 40 MG, 1X/DAY:QD | 21977 | 40 | MG | CAPSULE | QD | ||||||
| 123966115 | 12396611 | 2 | SS | ABILIFY | ARIPIPRAZOLE | 1 | Oral | 2.5 MG, 1X/DAY:QD | 82 | MG | Y | 0 | 2.5 | MG | QD | ||||
| 123966115 | 12396611 | 3 | SS | DESVENLAFAXINE /05742202/ | DESVENLAFAXINE SUCCINATE | 1 | Oral | 25 MG, 1X/DAY:QD | 8645 | MG | Y | U | 0 | 25 | MG | QD | |||
| 123966115 | 12396611 | 4 | SS | DESVENLAFAXINE /05742202/ | DESVENLAFAXINE SUCCINATE | 1 | Oral | 35 MG, 1X/DAY:QD | 8645 | MG | Y | U | 0 | 35 | MG | QD | |||
| 123966115 | 12396611 | 5 | SS | DESVENLAFAXINE /05742202/ | DESVENLAFAXINE SUCCINATE | 1 | Oral | 50 MG, 1X/DAY:QD | 8645 | MG | Y | U | 0 | 50 | MG | QD | |||
| 123966115 | 12396611 | 6 | SS | PRISTIQ EXTENDED-RELEASE | DESVENLAFAXINE SUCCINATE | 1 | Oral | 50 MG, 1X/DAY:QD | 850 | MG | 0 | 50 | MG | QD | |||||
| 123966115 | 12396611 | 7 | SS | PRISTIQ EXTENDED-RELEASE | DESVENLAFAXINE SUCCINATE | 1 | Oral | 100 MG, 1X/DAY:QD | 850 | MG | 0 | 100 | MG | QD | |||||
| 123966115 | 12396611 | 8 | C | MELATONIN | MELATONIN | 1 | Oral | 3 MG, 1X/DAY:QD (AT BEDTIME) | 0 | 3 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123966115 | 12396611 | 1 | Attention deficit/hyperactivity disorder |
| 123966115 | 12396611 | 2 | Mood swings |
| 123966115 | 12396611 | 3 | Depression |
| 123966115 | 12396611 | 6 | Depression |
| 123966115 | 12396611 | 8 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123966115 | 12396611 | HO |
| 123966115 | 12396611 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123966115 | 12396611 | Aggression | |
| 123966115 | 12396611 | Bipolar disorder | |
| 123966115 | 12396611 | Mania | |
| 123966115 | 12396611 | Suicidal behaviour |
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 |
|---|---|---|---|---|---|---|
| 123966115 | 12396611 | 1 | 20150826 | 0 | ||
| 123966115 | 12396611 | 2 | 20160202 | 20160305 | 0 | |
| 123966115 | 12396611 | 3 | 20150717 | 20150723 | 0 | |
| 123966115 | 12396611 | 4 | 20150724 | 20150814 | 0 | |
| 123966115 | 12396611 | 5 | 20150815 | 20160115 | 0 | |
| 123966115 | 12396611 | 6 | 20160116 | 20160307 | 0 | |
| 123966115 | 12396611 | 7 | 20160308 | 0 | ||
| 123966115 | 12396611 | 8 | 20160212 | 0 |