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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127367111 | 12736711 | 1 | I | 20160624 | 20160907 | 20160913 | 20160913 | EXP | PHHY2016BE125381 | NOVARTIS | 53.00 | YR | F | Y | 60.00000 | KG | 20160913 | CN | BE | BE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127367111 | 12736711 | 1 | PS | TEGRETOL | CARBAMAZEPINE | 1 | Oral | 400 MG, QD | Y | 16608 | 400 | MG | QD | ||||||
| 127367111 | 12736711 | 2 | SS | TEGRETOL | CARBAMAZEPINE | 1 | Oral | 600 MG, QD | Y | 16608 | 600 | MG | QD | ||||||
| 127367111 | 12736711 | 3 | SS | TEGRETOL | CARBAMAZEPINE | 1 | Oral | 500 MG, QD | Y | 16608 | 500 | MG | QD | ||||||
| 127367111 | 12736711 | 4 | SS | TEGRETOL | CARBAMAZEPINE | 1 | Oral | 700 MG, QD | Y | 16608 | 700 | MG | QD | ||||||
| 127367111 | 12736711 | 5 | SS | TEGRETOL | CARBAMAZEPINE | 1 | Oral | 800 MG, QD | Y | 16608 | 800 | MG | QD | ||||||
| 127367111 | 12736711 | 6 | SS | TEGRETOL | CARBAMAZEPINE | 1 | Oral | 600 MG, QD (3 X 200 MG) | Y | 16608 | 600 | MG | QD | ||||||
| 127367111 | 12736711 | 7 | SS | FYCOMPA | PERAMPANEL | 1 | Oral | 2 MG, QD | 0 | 2 | MG | QD | |||||||
| 127367111 | 12736711 | 8 | SS | DIPHANTOINE | PHENYTOIN | 1 | Oral | 200 MG, QD | Y | 0 | 200 | MG | QD | ||||||
| 127367111 | 12736711 | 9 | SS | DIPHANTOINE | PHENYTOIN | 1 | Oral | 100 MG, QD | Y | 0 | 100 | MG | QD | ||||||
| 127367111 | 12736711 | 10 | SS | DIPHANTOINE | PHENYTOIN | 1 | Oral | 150 MG, QD | Y | 0 | 150 | MG | QD | ||||||
| 127367111 | 12736711 | 11 | C | DEPAKINE CHRONO | VALPROATE SODIUM | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127367111 | 12736711 | 1 | Epilepsy |
| 127367111 | 12736711 | 7 | Epilepsy |
| 127367111 | 12736711 | 8 | Epilepsy |
| 127367111 | 12736711 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127367111 | 12736711 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127367111 | 12736711 | Hyponatraemia | |
| 127367111 | 12736711 | Toxicity to various agents |
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 |
|---|---|---|---|---|---|---|
| 127367111 | 12736711 | 1 | 201507 | 201510 | 0 | |
| 127367111 | 12736711 | 2 | 201510 | 20151231 | 0 | |
| 127367111 | 12736711 | 3 | 20160101 | 2016 | 0 | |
| 127367111 | 12736711 | 4 | 2016 | 2016 | 0 | |
| 127367111 | 12736711 | 5 | 2016 | 2016 | 0 | |
| 127367111 | 12736711 | 6 | 2016 | 0 | ||
| 127367111 | 12736711 | 7 | 20160603 | 0 | ||
| 127367111 | 12736711 | 8 | 201410 | 2016 | 0 | |
| 127367111 | 12736711 | 9 | 201608 | 201608 | 0 | |
| 127367111 | 12736711 | 10 | 201608 | 0 |