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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120703505 | 12070350 | 5 | F | 20160819 | 20160211 | 20160824 | PER | US-GLAXOSMITHKLINE-US2016GSK018359 | GLAXOSMITHKLINE | 0.00 | F | Y | 0.00000 | 20160824 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120703505 | 12070350 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | UNK | Y | U | 20241 | ||||||||
| 120703505 | 12070350 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 100 MG, U | Y | U | 20241 | 100 | MG | ||||||
| 120703505 | 12070350 | 3 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 150 MG, BID | Y | U | 20241 | 150 | MG | BID | |||||
| 120703505 | 12070350 | 4 | SS | LAMICTAL | LAMOTRIGINE | 1 | Unknown | 300 MG, BID | Y | U | 20241 | 300 | MG | BID | |||||
| 120703505 | 12070350 | 5 | SS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Unknown | 300 MG, BID | U | 20241 | 300 | MG | BID | ||||||
| 120703505 | 12070350 | 6 | SS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Unknown | 100 MG, U | U | 20241 | 100 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120703505 | 12070350 | 1 | Seizure |
| 120703505 | 12070350 | 5 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120703505 | 12070350 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120703505 | 12070350 | Anal pruritus | |
| 120703505 | 12070350 | Atrophic vulvovaginitis | |
| 120703505 | 12070350 | Candida infection | |
| 120703505 | 12070350 | Dermatitis | |
| 120703505 | 12070350 | Fungal infection | |
| 120703505 | 12070350 | Rash | |
| 120703505 | 12070350 | Rash generalised | |
| 120703505 | 12070350 | Skin candida | |
| 120703505 | 12070350 | Stevens-Johnson syndrome | |
| 120703505 | 12070350 | Tinea cruris | |
| 120703505 | 12070350 | Urticaria | |
| 120703505 | 12070350 | Vulvovaginal candidiasis | |
| 120703505 | 12070350 | Vulvovaginal pruritus |
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 |
|---|---|---|---|---|---|---|
| 120703505 | 12070350 | 1 | 20150612 | 0 | ||
| 120703505 | 12070350 | 2 | 20051201 | 0 | ||
| 120703505 | 12070350 | 3 | 20070727 | 0 | ||
| 120703505 | 12070350 | 5 | 20070520 | 0 | ||
| 120703505 | 12070350 | 6 | 20070521 | 20150612 | 0 |