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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125640801 | 12564080 | 1 | I | 20160624 | 20160704 | 20160718 | 20160718 | EXP | GB-AUROBINDO-AUR-APL-2016-08855 | AUROBINDO | 55.00 | YR | F | Y | 0.00000 | 20160718 | PH | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125640801 | 12564080 | 1 | PS | Lamotrigine 200mg | LAMOTRIGINE | 1 | Oral | 200 MG, TWO TIMES A DAY | 78956 | 200 | MG | BID | |||||||
| 125640801 | 12564080 | 2 | SS | CARBAMAZEPINE. | CARBAMAZEPINE | 1 | Oral | 800 MG, TWO TIMES A DAY | 0 | 800 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125640801 | 12564080 | 1 | Epilepsy |
| 125640801 | 12564080 | 2 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125640801 | 12564080 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125640801 | 12564080 | Ataxia | |
| 125640801 | 12564080 | Dysarthria | |
| 125640801 | 12564080 | Feeling abnormal | |
| 125640801 | 12564080 | Nystagmus |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |