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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123656984 | 12365698 | 4 | F | 20160712 | 20160513 | 20160718 | EXP | GB-GLAXOSMITHKLINE-GB2016GSK066611 | GLAXOSMITHKLINE | 5.00 | DEC | F | Y | 0.00000 | 20160718 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123656984 | 12365698 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | U | 20241 | |||||||||||
| 123656984 | 12365698 | 2 | SS | TOPAMAX | TOPIRAMATE | 1 | 400 MG, UNK | U | 0 | 400 | MG | ||||||||
| 123656984 | 12365698 | 3 | SS | ZONEGRAN | ZONISAMIDE | 1 | 550 MG, UNK | U | 0 | 550 | MG | ||||||||
| 123656984 | 12365698 | 4 | SS | ZONEGRAN | ZONISAMIDE | 1 | U | 0 | |||||||||||
| 123656984 | 12365698 | 5 | SS | KEPPRA | LEVETIRACETAM | 1 | UNK | U | 0 | ||||||||||
| 123656984 | 12365698 | 6 | SS | BOTOX | ONABOTULINUMTOXINA | 1 | Intravenous (not otherwise specified) | UNK, SINGLE | 0 | SOLUTION FOR INJECTION | |||||||||
| 123656984 | 12365698 | 7 | SS | BOTOX | ONABOTULINUMTOXINA | 1 | Intravenous (not otherwise specified) | UNK, SINGLE | 0 | SOLUTION FOR INJECTION | |||||||||
| 123656984 | 12365698 | 8 | SS | Clobazam | CLOBAZAM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123656984 | 12365698 | 1 | Product used for unknown indication |
| 123656984 | 12365698 | 2 | Product used for unknown indication |
| 123656984 | 12365698 | 3 | Generalised tonic-clonic seizure |
| 123656984 | 12365698 | 4 | Complex partial seizures |
| 123656984 | 12365698 | 5 | Product used for unknown indication |
| 123656984 | 12365698 | 6 | Seizure |
| 123656984 | 12365698 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123656984 | 12365698 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123656984 | 12365698 | Alopecia | |
| 123656984 | 12365698 | Brain injury | |
| 123656984 | 12365698 | Drug ineffective for unapproved indication | |
| 123656984 | 12365698 | Fatigue | |
| 123656984 | 12365698 | Incorrect route of drug administration | |
| 123656984 | 12365698 | Off label use | |
| 123656984 | 12365698 | Onychomadesis | |
| 123656984 | 12365698 | Peripheral coldness | |
| 123656984 | 12365698 | Seizure | |
| 123656984 | 12365698 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 123656984 | 12365698 | 2 | 2014 | 0 | ||
| 123656984 | 12365698 | 3 | 2014 | 0 | ||
| 123656984 | 12365698 | 6 | 201512 | 201512 | 0 | |
| 123656984 | 12365698 | 7 | 201603 | 201603 | 0 |