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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118102256 | 11810225 | 6 | F | 2014 | 20160711 | 20151208 | 20160713 | EXP | US-SUNOVION-2015SUN001163 | SUNOVION | 30.27 | YR | F | Y | 92.52000 | KG | 20160713 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118102256 | 11810225 | 1 | PS | APTIOM | ESLICARBAZEPINE ACETATE | 1 | Oral | 800 MG, HS | 107200 | MG | Y | UNKNOWN | 22416 | 800 | MG | TABLET | QD | ||
| 118102256 | 11810225 | 2 | SS | LYRICA | PREGABALIN | 1 | Unknown | UNK | Y | 0 | |||||||||
| 118102256 | 11810225 | 3 | SS | LYRICA | PREGABALIN | 1 | Unknown | 150 MG, BID | Y | 0 | 150 | MG | BID | ||||||
| 118102256 | 11810225 | 4 | SS | LYRICA | PREGABALIN | 1 | Unknown | 28800 MG, SINGLE | Y | 0 | 28800 | MG | QD | ||||||
| 118102256 | 11810225 | 5 | SS | LYRICA | PREGABALIN | 1 | Unknown | UNK | Y | 0 | |||||||||
| 118102256 | 11810225 | 6 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 100 MG, QD | 0 | 100 | MG | QD | |||||||
| 118102256 | 11810225 | 7 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 200 MG, QD | 0 | 200 | MG | QD | |||||||
| 118102256 | 11810225 | 8 | C | FOLVITE | FOLIC ACID | 1 | Oral | 2 MG, BID | 0 | 2 | MG | BID | |||||||
| 118102256 | 11810225 | 9 | C | DEPAKOTE | DIVALPROEX SODIUM | 1 | Oral | 500 MG, BID | 0 | 500 | MG | BID | |||||||
| 118102256 | 11810225 | 10 | C | TRILEPTAL | OXCARBAZEPINE | 1 | Unknown | UNK | 0 | ||||||||||
| 118102256 | 11810225 | 11 | C | KEPPRA | LEVETIRACETAM | 1 | Unknown | UNK | 0 | ||||||||||
| 118102256 | 11810225 | 12 | C | Ferrous Gluconate | FERROUS GLUCONATE | 1 | Oral | 324 MG, QD | 0 | 324 | MG | QD | |||||||
| 118102256 | 11810225 | 13 | C | Melatonin | MELATONIN | 1 | Oral | 3 MG, HS | 0 | 3 | MG | TABLET | QD | ||||||
| 118102256 | 11810225 | 14 | C | VITAMIN D2 | ERGOCALCIFEROL | 1 | Oral | 50000 DF, EVERY TWO WEEKS | 0 | 50000 | DF | ||||||||
| 118102256 | 11810225 | 15 | C | TEGRETOL | CARBAMAZEPINE | 1 | Unknown | 100 MG, QD | 0 | 100 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118102256 | 11810225 | 1 | Partial seizures |
| 118102256 | 11810225 | 2 | Epilepsy |
| 118102256 | 11810225 | 6 | Depression |
| 118102256 | 11810225 | 8 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118102256 | 11810225 | HO |
| 118102256 | 11810225 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118102256 | 11810225 | Abasia | |
| 118102256 | 11810225 | Aggression | |
| 118102256 | 11810225 | Aphasia | |
| 118102256 | 11810225 | Confusional state | |
| 118102256 | 11810225 | Depressed mood | |
| 118102256 | 11810225 | Diarrhoea | |
| 118102256 | 11810225 | Dizziness | |
| 118102256 | 11810225 | Dreamy state | |
| 118102256 | 11810225 | Fatigue | |
| 118102256 | 11810225 | Feeling abnormal | |
| 118102256 | 11810225 | Hunger | |
| 118102256 | 11810225 | Hypoglycaemia | |
| 118102256 | 11810225 | Hyponatraemia | |
| 118102256 | 11810225 | Impulsive behaviour | |
| 118102256 | 11810225 | Irritability | |
| 118102256 | 11810225 | Memory impairment | |
| 118102256 | 11810225 | Movement disorder | |
| 118102256 | 11810225 | Partial seizures | |
| 118102256 | 11810225 | Seizure | |
| 118102256 | 11810225 | Speech disorder | |
| 118102256 | 11810225 | Suicidal ideation | |
| 118102256 | 11810225 | Suicide attempt | |
| 118102256 | 11810225 | Tardive dyskinesia | |
| 118102256 | 11810225 | Time perception altered | |
| 118102256 | 11810225 | Urinary incontinence | |
| 118102256 | 11810225 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 118102256 | 11810225 | 1 | 201412 | 20150417 | 0 | |
| 118102256 | 11810225 | 2 | 20100813 | 0 | ||
| 118102256 | 11810225 | 4 | 20150416 | 20150416 | 0 | |
| 118102256 | 11810225 | 6 | 2013 | 0 |