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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120760302 | 12076030 | 2 | F | 201512 | 20160912 | 20160215 | 20160915 | EXP | GB-MHRA-EYC 00134185 | GB-GLENMARK PHARMACEUTICALS INC, USA.-2016GMK021970 | GLENMARK | 0.00 | Y | 0.00000 | 20160915 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120760302 | 12076030 | 1 | PS | TOPIRAMATE. | TOPIRAMATE | 1 | Oral | 50 MG, BID | Y | 77627 | 50 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120760302 | 12076030 | 1 | Migraine |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120760302 | 12076030 | OT |
| 120760302 | 12076030 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120760302 | 12076030 | Central nervous system lesion | |
| 120760302 | 12076030 | Headache | |
| 120760302 | 12076030 | Noninfective encephalitis | |
| 120760302 | 12076030 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 120760302 | 12076030 | 1 | 201509 | 201512 | 0 |