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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126100773 | 12610077 | 3 | F | 20160801 | 20160801 | 20160808 | EXP | PHHY2016VE104348 | NOVARTIS | 0.00 | M | Y | 0.00000 | 20160808 | MD | VE | VE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126100773 | 12610077 | 1 | PS | TEGRETOL | CARBAMAZEPINE | 1 | Oral | 600 MG, QD (400 MG IN THE MORNING AND 200 MG IN THE AFTERNOON) | 16608 | 600 | MG | TABLET | QD | ||||||
| 126100773 | 12610077 | 2 | SS | TEGRETOL | CARBAMAZEPINE | 1 | Oral | 100 MG, BID (100 MG IN THE MORNING AND 100 MG IN THE AFTERNOON) | 16608 | 100 | MG | TABLET | BID | ||||||
| 126100773 | 12610077 | 3 | SS | TOPIRAMATE. | TOPIRAMATE | 1 | Oral | 200 MG, QD (150 MG AND 50 IN THE AFTERNOON) | 0 | 200 | MG | QD | |||||||
| 126100773 | 12610077 | 4 | SS | TOPIRAMATE. | TOPIRAMATE | 1 | 150 MG, QD (100 MG AND 50 MG) | 0 | 150 | MG | QD | ||||||||
| 126100773 | 12610077 | 5 | C | VALPRON//VALPROATE SODIUM | VALPROATE SODIUM | 1 | Unknown | 1750 MG, QD | U | 0 | 1750 | MG | QD | ||||||
| 126100773 | 12610077 | 6 | C | VALCOTE | VALPROATE SODIUM | 1 | Unknown | 1750 MG, QD | U | 0 | 1750 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126100773 | 12610077 | 1 | Brain neoplasm |
| 126100773 | 12610077 | 2 | Seizure |
| 126100773 | 12610077 | 3 | Brain neoplasm |
| 126100773 | 12610077 | 5 | Seizure |
| 126100773 | 12610077 | 6 | Neoplasm |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126100773 | 12610077 | HO |
| 126100773 | 12610077 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126100773 | 12610077 | Anxiety | |
| 126100773 | 12610077 | Aphonia | |
| 126100773 | 12610077 | Epilepsy | |
| 126100773 | 12610077 | Excessive eye blinking | |
| 126100773 | 12610077 | Facial paralysis | |
| 126100773 | 12610077 | Malaise | |
| 126100773 | 12610077 | Micturition urgency | |
| 126100773 | 12610077 | Product use issue | |
| 126100773 | 12610077 | Seizure | |
| 126100773 | 12610077 | Stress | |
| 126100773 | 12610077 | Tongue biting | |
| 126100773 | 12610077 | 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
| no results found |