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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124818704 | 12481870 | 4 | F | 20160610 | 20160728 | 20160620 | 20160804 | PER | PHEH2016US014788 | NOVARTIS | 7.01 | YR | F | Y | 21.90000 | KG | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124818704 | 12481870 | 1 | PS | TRILEPTAL | OXCARBAZEPINE | 1 | Unknown | UNK | 21014 | ||||||||||
| 124818704 | 12481870 | 2 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 1050 MG, QD ((450MG AM, 600MG PM) ) | 21014 | 1050 | MG | QD | |||||||
| 124818704 | 12481870 | 3 | SS | OXCARBAZEPINE. | OXCARBAZEPINE | 1 | Unknown | 6 ML, BID | U | H0080 | 21014 | 6 | ML | BID | |||||
| 124818704 | 12481870 | 4 | SS | OXCARBAZEPINE. | OXCARBAZEPINE | 1 | Unknown | 8 ML, UNK | U | 21014 | 8 | ML | |||||||
| 124818704 | 12481870 | 5 | SS | OXCARBAZEPINE. | OXCARBAZEPINE | 1 | Unknown | 6 ML, UNK | U | 21014 | 6 | ML | |||||||
| 124818704 | 12481870 | 6 | SS | FELBATOL | FELBAMATE | 1 | Unknown | 0 | |||||||||||
| 124818704 | 12481870 | 7 | SS | FELBATOL | FELBAMATE | 1 | Oral | 1530 MG, QD (720MG AM, 450MG NOON, 360MG PM ) | 0 | 1530 | MG | QD | |||||||
| 124818704 | 12481870 | 8 | SS | MIDAZOLAM | MIDAZOLAMMIDAZOLAM HYDROCHLORIDE | 1 | Unknown | 3 ML, UNK | 0 | 3 | ML | ||||||||
| 124818704 | 12481870 | 9 | SS | MIDAZOLAM | MIDAZOLAMMIDAZOLAM HYDROCHLORIDE | 1 | Oral | 6 MG, PRN | 0 | 6 | MG | ||||||||
| 124818704 | 12481870 | 10 | C | FELBAMATE. | FELBAMATE | 1 | Unknown | 6ML QAM 4ML AT NOON AND 3 5 PM | 0 | 13 | ML | ||||||||
| 124818704 | 12481870 | 11 | C | FIBER | PSYLLIUM HUSK | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124818704 | 12481870 | 1 | Epilepsy |
| 124818704 | 12481870 | 3 | Epilepsy |
| 124818704 | 12481870 | 4 | Partial seizures |
| 124818704 | 12481870 | 6 | Partial seizures |
| 124818704 | 12481870 | 8 | Seizure |
| 124818704 | 12481870 | 10 | Seizure |
| 124818704 | 12481870 | 11 | Constipation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124818704 | 12481870 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124818704 | 12481870 | Drug ineffective | |
| 124818704 | 12481870 | Generalised tonic-clonic seizure | |
| 124818704 | 12481870 | Partial seizures | |
| 124818704 | 12481870 | Seizure |
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 |
|---|---|---|---|---|---|---|
| 124818704 | 12481870 | 1 | 201510 | 0 | ||
| 124818704 | 12481870 | 2 | 20151109 | 0 | ||
| 124818704 | 12481870 | 3 | 201510 | 0 | ||
| 124818704 | 12481870 | 7 | 20160224 | 0 | ||
| 124818704 | 12481870 | 9 | 20151109 | 0 |