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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125152682 | 12515268 | 2 | F | 2016 | 20160726 | 20160630 | 20160802 | EXP | US-SHIRE-US201607650 | SHIRE | 0.00 | M | Y | 108.84000 | KG | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125152682 | 12515268 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | UNK, UNK, 2X/DAY:BID (OPEN AND DIVIDE A 70 MG CAPSULE INTO TWO UNKNOWN MG DOSES DAILY) | AF4233B | 21977 | CAPSULE | BID | |||||||
| 125152682 | 12515268 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | 21977 | CAPSULE | |||||||||||
| 125152682 | 12515268 | 3 | C | LITHIUM. | LITHIUM | 1 | Oral | 900 MG, 2X/DAY:BID | 0 | 900 | MG | CAPSULE | BID | ||||||
| 125152682 | 12515268 | 4 | C | LITHIUM. | LITHIUM | 1 | 0 | CAPSULE | |||||||||||
| 125152682 | 12515268 | 5 | C | LATUDA | LURASIDONE HYDROCHLORIDE | 1 | Oral | 80 MG, 1X/DAY:QD (NIGHTLY) | 0 | 80 | MG | TABLET | QD | ||||||
| 125152682 | 12515268 | 6 | C | LATUDA | LURASIDONE HYDROCHLORIDE | 1 | 0 | TABLET | |||||||||||
| 125152682 | 12515268 | 7 | C | LAMICTAL | LAMOTRIGINE | 1 | Oral | 200 MG, 2X/DAY:BID | 0 | 200 | MG | TABLET | BID | ||||||
| 125152682 | 12515268 | 8 | C | LAMICTAL | LAMOTRIGINE | 1 | 0 | TABLET | |||||||||||
| 125152682 | 12515268 | 9 | C | KLONOPIN | CLONAZEPAM | 1 | Oral | 1 MG, AS REQ'D | 0 | 1 | MG | TABLET | |||||||
| 125152682 | 12515268 | 10 | C | KLONOPIN | CLONAZEPAM | 1 | 0 | TABLET | |||||||||||
| 125152682 | 12515268 | 11 | C | PERCOCET /00446701/ | ACETAMINOPHENOXYCODONE HYDROCHLORIDEOXYCODONE TEREPHTHALATE | 1 | Oral | 10 MG, AS REQ'D (UP TO 3 TIMES A DAY) | 0 | 10 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125152682 | 12515268 | 1 | Depression |
| 125152682 | 12515268 | 2 | Bipolar disorder |
| 125152682 | 12515268 | 3 | Bipolar disorder |
| 125152682 | 12515268 | 4 | Depression |
| 125152682 | 12515268 | 5 | Bipolar disorder |
| 125152682 | 12515268 | 6 | Depression |
| 125152682 | 12515268 | 7 | Bipolar disorder |
| 125152682 | 12515268 | 8 | Depression |
| 125152682 | 12515268 | 9 | Anxiety |
| 125152682 | 12515268 | 10 | Sleep disorder |
| 125152682 | 12515268 | 11 | Arthralgia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125152682 | 12515268 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125152682 | 12515268 | Inappropriate schedule of drug administration | |
| 125152682 | 12515268 | Incorrect dose administered | |
| 125152682 | 12515268 | Major depression | |
| 125152682 | 12515268 | Obsessive-compulsive disorder | |
| 125152682 | 12515268 | Product use issue | |
| 125152682 | 12515268 | 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 |
|---|---|---|---|---|---|---|
| 125152682 | 12515268 | 1 | 2016 | 0 | ||
| 125152682 | 12515268 | 11 | 2004 | 0 |