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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116136405 | 11613640 | 5 | F | 20150918 | 20160823 | 20151008 | 20160826 | EXP | JP-GLAXOSMITHKLINE-JP2015JPN142003 | GLAXOSMITHKLINE | 32.55 | YR | F | Y | 53.00000 | KG | 20160826 | CN | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116136405 | 11613640 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 25 MG, QOD | 125 | MG | Y | 20241 | 25 | MG | TABLET | QOD | |||
| 116136405 | 11613640 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 25 MG, QD | 125 | MG | Y | 20241 | 25 | MG | TABLET | QD | |||
| 116136405 | 11613640 | 3 | SS | ZITHROMAC | AZITHROMYCIN DIHYDRATE | 1 | Oral | 500 MG, 1D | 1500 | MG | Y | 0 | 500 | MG | QD | ||||
| 116136405 | 11613640 | 4 | C | COUGHCODE-N | ACETAMINOPHENBROMISOVALDIHYDROCODEINE PHOSPHATEDIPHENHYDRAMINE SALICYLATEDYPHYLLINEMETHYLEPHEDRINE HYDROCHLORIDE, (+/-)- | 1 | 0 | ||||||||||||
| 116136405 | 11613640 | 5 | C | MUCOSOLVAN | AMBROXOL HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 116136405 | 11613640 | 6 | C | ALLEGRA | FEXOFENADINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 116136405 | 11613640 | 7 | C | DEPAKENE | VALPROIC ACID | 1 | 300 MG, BID | 0 | 300 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116136405 | 11613640 | 1 | Epilepsy |
| 116136405 | 11613640 | 3 | Antibiotic prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116136405 | 11613640 | OT |
| 116136405 | 11613640 | LT |
| 116136405 | 11613640 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116136405 | 11613640 | Conjunctival hyperaemia | |
| 116136405 | 11613640 | Dysgeusia | |
| 116136405 | 11613640 | Hepatic function abnormal | |
| 116136405 | 11613640 | Lip erosion | |
| 116136405 | 11613640 | Lip swelling | |
| 116136405 | 11613640 | Ocular hyperaemia | |
| 116136405 | 11613640 | Oculomucocutaneous syndrome | |
| 116136405 | 11613640 | Oral mucosa erosion | |
| 116136405 | 11613640 | Pyrexia | |
| 116136405 | 11613640 | Rash |
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 |
|---|---|---|---|---|---|---|
| 116136405 | 11613640 | 1 | 20150902 | 20150915 | 0 | |
| 116136405 | 11613640 | 2 | 20150916 | 20150928 | 0 | |
| 116136405 | 11613640 | 3 | 20150918 | 20150928 | 0 | |
| 116136405 | 11613640 | 7 | 20150902 | 0 |