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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109063558 | 10906355 | 8 | F | 2013 | 20160804 | 20150312 | 20160808 | EXP | PHHY2013FR141550 | NOVARTIS | 36.00 | YR | M | Y | 71.00000 | KG | 20160808 | CN | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109063558 | 10906355 | 1 | PS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 300 MG, BID (IN THE MORNING AND IN THE EVENING) | Y | 21014 | 300 | MG | TABLET | BID | |||||
| 109063558 | 10906355 | 2 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 450 MG, QD (300 MG IN THE MORNING AND 150 MG IN THE EVENING) | Y | 21014 | 450 | MG | TABLET | QD | |||||
| 109063558 | 10906355 | 3 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 300 MG IN THE MORNING AND 450 MG IN THE EVENING | Y | 21014 | TABLET | ||||||||
| 109063558 | 10906355 | 4 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 150 MG, BID | Y | 21014 | 150 | MG | TABLET | BID | |||||
| 109063558 | 10906355 | 5 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 150 MG, BID | Y | 21014 | 150 | MG | TABLET | BID | |||||
| 109063558 | 10906355 | 6 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 0.5 DF, QD (CONCENTRATION 150 MG) | Y | 21014 | .5 | DF | TABLET | QD | |||||
| 109063558 | 10906355 | 7 | C | URBANYL | CLOBAZAM | 1 | Unknown | U | 0 | ||||||||||
| 109063558 | 10906355 | 8 | C | KEPPRA | LEVETIRACETAM | 1 | Oral | 250 MG, BID (IN THE MORNING AND IN THE EVENING) | U | 0 | 250 | MG | BID | ||||||
| 109063558 | 10906355 | 9 | C | VALIUM | DIAZEPAM | 1 | Oral | UNK, QD | U | 0 | TABLET | QD | |||||||
| 109063558 | 10906355 | 10 | C | VALIUM | DIAZEPAM | 1 | U | 0 | TABLET | ||||||||||
| 109063558 | 10906355 | 11 | C | HEPTAMYL | HEPTAMINOL HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 109063558 | 10906355 | 12 | C | CERIS | TROSPIUM CHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 109063558 | 10906355 | 13 | C | THERALENE | TRIMEPRAZINE | 1 | Unknown | 0 | |||||||||||
| 109063558 | 10906355 | 14 | C | KERATYL | 2 | Unknown | U | 0 | |||||||||||
| 109063558 | 10906355 | 15 | C | SEROPLEX | ESCITALOPRAM OXALATE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109063558 | 10906355 | 1 | Epilepsy |
| 109063558 | 10906355 | 7 | Product used for unknown indication |
| 109063558 | 10906355 | 8 | Epilepsy |
| 109063558 | 10906355 | 9 | Suicidal ideation |
| 109063558 | 10906355 | 10 | Suicide attempt |
| 109063558 | 10906355 | 11 | Product used for unknown indication |
| 109063558 | 10906355 | 12 | Product used for unknown indication |
| 109063558 | 10906355 | 13 | Product used for unknown indication |
| 109063558 | 10906355 | 14 | Product used for unknown indication |
| 109063558 | 10906355 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109063558 | 10906355 | OT |
| 109063558 | 10906355 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109063558 | 10906355 | Alopecia | |
| 109063558 | 10906355 | Anxiety | |
| 109063558 | 10906355 | Arrhythmia | |
| 109063558 | 10906355 | Constipation | |
| 109063558 | 10906355 | Decreased appetite | |
| 109063558 | 10906355 | Depressed mood | |
| 109063558 | 10906355 | Dizziness | |
| 109063558 | 10906355 | Dysphonia | |
| 109063558 | 10906355 | Fatigue | |
| 109063558 | 10906355 | Feeling abnormal | |
| 109063558 | 10906355 | Headache | |
| 109063558 | 10906355 | Loss of consciousness | |
| 109063558 | 10906355 | Memory impairment | |
| 109063558 | 10906355 | Negative thoughts | |
| 109063558 | 10906355 | Nervousness | |
| 109063558 | 10906355 | Seizure | |
| 109063558 | 10906355 | Sensation of foreign body | |
| 109063558 | 10906355 | Speech disorder | |
| 109063558 | 10906355 | Suicidal ideation | |
| 109063558 | 10906355 | Suicide attempt | |
| 109063558 | 10906355 | Toxicity to various agents | |
| 109063558 | 10906355 | 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 |
|---|---|---|---|---|---|---|
| 109063558 | 10906355 | 1 | 20130422 | 20131105 | 0 | |
| 109063558 | 10906355 | 2 | 201411 | 0 | ||
| 109063558 | 10906355 | 3 | 201412 | 0 | ||
| 109063558 | 10906355 | 4 | 201412 | 0 | ||
| 109063558 | 10906355 | 5 | 201506 | 0 | ||
| 109063558 | 10906355 | 6 | 201512 | 0 | ||
| 109063558 | 10906355 | 8 | 201506 | 0 | ||
| 109063558 | 10906355 | 13 | 201502 | 0 |