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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126706812 | 12670681 | 2 | F | 20160808 | 20160822 | 20160822 | EXP | TR-CIPLA LTD.-2016TR17394 | CIPLA | BEKTAS G, CALISKAN M, AYDIN A, YILDIZ EP, TATLI B, AYDINLI N, ET AL.,. AGGRAVATION OF ATONIC SEIZURES BY RUFINAMIDE: A CASE REPORT. BRAIN + DEVELOPMENT. 2016;38:654 TO 657 | 0.00 | Y | 0.00000 | 20160822 | OT | TR | TR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126706812 | 12670681 | 1 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Unknown | 3000 MG, PER DAY | U | U | 0 | 3000 | MG | ||||||
| 126706812 | 12670681 | 2 | PS | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | UNK | U | U | 76343 | ||||||||
| 126706812 | 12670681 | 3 | SS | VALPROIC ACID. | VALPROIC ACID | 1 | Unknown | 3000 MG, PER DAY | U | U | 0 | 3000 | MG | ||||||
| 126706812 | 12670681 | 4 | SS | Rufinamide | RUFINAMIDE | 1 | Unknown | 100 MG, PER DAY, BASELINE | U | 0 | 100 | MG | |||||||
| 126706812 | 12670681 | 5 | SS | Rufinamide | RUFINAMIDE | 1 | Unknown | UNK, DOSE TITRATED WITH AN INCREMENT OF 50 MG EVERY 3 DAYS UP TO 250 MG/DAY OVER 2 WEEKS | U | 0 | |||||||||
| 126706812 | 12670681 | 6 | SS | Vigabatrin | VIGABATRIN | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 126706812 | 12670681 | 7 | SS | PHENOBARBITAL. | PHENOBARBITAL | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 126706812 | 12670681 | 8 | SS | Clobazam | CLOBAZAM | 1 | Unknown | 40 MG, PER DAY | U | U | 0 | 40 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126706812 | 12670681 | 1 | Atonic seizures |
| 126706812 | 12670681 | 2 | Seizure |
| 126706812 | 12670681 | 3 | Atonic seizures |
| 126706812 | 12670681 | 4 | Atonic seizures |
| 126706812 | 12670681 | 6 | Seizure |
| 126706812 | 12670681 | 7 | Seizure |
| 126706812 | 12670681 | 8 | Atonic seizures |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126706812 | 12670681 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126706812 | 12670681 | Condition aggravated | |
| 126706812 | 12670681 | Drug ineffective |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |