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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122696032 | 12269603 | 2 | F | 20150501 | 20160920 | 20160414 | 20160922 | EXP | CZ-JNJFOC-20160406023 | JANSSEN | 8.00 | YR | C | F | Y | 36.00000 | KG | 20160922 | MD | CZ | CZ |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122696032 | 12269603 | 1 | SS | TOPAMAX | TOPIRAMATE | 1 | Oral | N | 0 | 25 | MG | TABLETS | BID | ||||||
| 122696032 | 12269603 | 2 | PS | TOPAMAX | TOPIRAMATE | 1 | Oral | N | 20505 | TABLETS | |||||||||
| 122696032 | 12269603 | 3 | SS | PREGABALIN. | PREGABALIN | 1 | Oral | Y | 0 | 2.5 | MG/KG | UNSPECIFIED | |||||||
| 122696032 | 12269603 | 4 | SS | TIMONIL | CARBAMAZEPINE | 1 | Oral | 0 | 150 | MG | UNSPECIFIED | BID | |||||||
| 122696032 | 12269603 | 5 | SS | TIMONIL | CARBAMAZEPINE | 1 | Oral | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122696032 | 12269603 | 1 | Partial seizures |
| 122696032 | 12269603 | 2 | Partial seizures |
| 122696032 | 12269603 | 3 | Partial seizures |
| 122696032 | 12269603 | 4 | Partial seizures |
| 122696032 | 12269603 | 5 | Partial seizures |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122696032 | 12269603 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122696032 | 12269603 | Aggression | |
| 122696032 | 12269603 | Hallucination | |
| 122696032 | 12269603 | Mood altered | |
| 122696032 | 12269603 | Psychotic disorder | |
| 122696032 | 12269603 | 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 |
|---|---|---|---|---|---|---|
| 122696032 | 12269603 | 1 | 20151002 | 0 | ||
| 122696032 | 12269603 | 2 | 20150423 | 0 | ||
| 122696032 | 12269603 | 3 | 20160121 | 20160317 | 0 | |
| 122696032 | 12269603 | 4 | 20151002 | 0 | ||
| 122696032 | 12269603 | 5 | 201501 | 0 |