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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118138244 | 11813824 | 4 | F | 2012 | 20160826 | 20151209 | 20160901 | EXP | CN-GLAXOSMITHKLINE-CN2015GSK174254 | GLAXOSMITHKLINE | 26.00 | YR | M | Y | 55.00000 | KG | 20160901 | CN | CN | CN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118138244 | 11813824 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 25 MG, QD | ZB0989 | 20241 | 25 | MG | TABLET | QD | |||||
| 118138244 | 11813824 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | 20241 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118138244 | 11813824 | 1 | Intellectual disability |
| 118138244 | 11813824 | 2 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118138244 | 11813824 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118138244 | 11813824 | Chromaturia | |
| 118138244 | 11813824 | Eye discharge | |
| 118138244 | 11813824 | Haematemesis | |
| 118138244 | 11813824 | Hair growth abnormal | |
| 118138244 | 11813824 | Muscle twitching | |
| 118138244 | 11813824 | Ocular hyperaemia | |
| 118138244 | 11813824 | Penile haemorrhage | |
| 118138244 | 11813824 | Product use issue | |
| 118138244 | 11813824 | Pruritus genital | |
| 118138244 | 11813824 | Tooth discolouration | |
| 118138244 | 11813824 | Vomiting | |
| 118138244 | 11813824 | 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 |
|---|---|---|---|---|---|---|
| 118138244 | 11813824 | 1 | 2012 | 0 |