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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107499186 | 10749918 | 6 | F | 20150119 | 20160822 | 20150129 | 20160830 | EXP | BR-LUNDBECK-DKLU1108104 | LUNDBECK | 32.00 | YR | M | Y | 0.00000 | 20160830 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107499186 | 10749918 | 1 | PS | Frisium | CLOBAZAM | 1 | Oral | U | 412234,519544,5E1572 | 202067 | TABLET | ||||||||
| 107499186 | 10749918 | 2 | SS | Frisium | CLOBAZAM | 1 | Oral | U | 412234,519544,5E1572 | 202067 | TABLET | BID | |||||||
| 107499186 | 10749918 | 3 | SS | Frisium | CLOBAZAM | 1 | Oral | U | 412234,519544,5E1572 | 202067 | TABLET | BID | |||||||
| 107499186 | 10749918 | 4 | SS | Frisium | CLOBAZAM | 1 | Oral | U | 412234,519544,5E1572 | 202067 | 10 | MG | TABLET | BID | |||||
| 107499186 | 10749918 | 5 | SS | Frisium | CLOBAZAM | 1 | Oral | U | 412234,519544,5E1572 | 202067 | TABLET | ||||||||
| 107499186 | 10749918 | 6 | SS | Urbanil | CLOBAZAM | 1 | Oral | U | 535744 | 202067 | 20 | MG | TABLET | QD | |||||
| 107499186 | 10749918 | 7 | SS | GARDENAL | PHENOBARBITAL | 1 | Parenteral | U | 0 | ||||||||||
| 107499186 | 10749918 | 8 | SS | TOPIRAMATE. | TOPIRAMATE | 1 | Oral | U | 769403 | 0 | 50 | MG | TABLET | BID | |||||
| 107499186 | 10749918 | 9 | SS | TOPIRAMATE. | TOPIRAMATE | 1 | Oral | U | 769403 | 0 | 100 | MG | TABLET | BID | |||||
| 107499186 | 10749918 | 10 | SS | CARBAMAZEPINE. | CARBAMAZEPINE | 1 | Oral | U | 1535773 | 0 | 1400 | MG | TABLET | QD | |||||
| 107499186 | 10749918 | 11 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | 0 | |||||||||||
| 107499186 | 10749918 | 12 | C | FLUOCORTOLONE | FLUOCORTOLONE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 107499186 | 10749918 | 1 | Epilepsy |
| 107499186 | 10749918 | 6 | Epilepsy |
| 107499186 | 10749918 | 7 | Epilepsy |
| 107499186 | 10749918 | 8 | Epilepsy |
| 107499186 | 10749918 | 10 | Epilepsy |
| 107499186 | 10749918 | 11 | Product used for unknown indication |
| 107499186 | 10749918 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 107499186 | 10749918 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 107499186 | 10749918 | Amnesia | |
| 107499186 | 10749918 | Breath odour | |
| 107499186 | 10749918 | Confusional state | |
| 107499186 | 10749918 | Decreased appetite | |
| 107499186 | 10749918 | Drug ineffective | |
| 107499186 | 10749918 | Epilepsy | |
| 107499186 | 10749918 | Malaise | |
| 107499186 | 10749918 | Nervousness | |
| 107499186 | 10749918 | Overdose | |
| 107499186 | 10749918 | Social avoidant behaviour | |
| 107499186 | 10749918 | Tremor | |
| 107499186 | 10749918 | 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
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 107499186 | 10749918 | 1 | 20150117 | 0 | ||
| 107499186 | 10749918 | 2 | 20150119 | 20150119 | 0 | |
| 107499186 | 10749918 | 4 | 20150508 | 0 | ||
| 107499186 | 10749918 | 5 | 2015 | 0 | ||
| 107499186 | 10749918 | 6 | 2010 | 0 | ||
| 107499186 | 10749918 | 7 | 20150118 | 20150118 | 0 | |
| 107499186 | 10749918 | 8 | 2008 | 0 | ||
| 107499186 | 10749918 | 10 | 2005 | 0 | ||
| 107499186 | 10749918 | 11 | 20150115 | 20150115 | 0 |