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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125843791 | 12584379 | 1 | I | 201606 | 20160719 | 20160722 | 20160722 | EXP | DK-DKMA-WBS-0003977 | DK-GLAXOSMITHKLINE-DK2016103469 | GLAXOSMITHKLINE | 56.77 | YR | F | Y | 0.00000 | 20160722 | MD | DK | DK |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125843791 | 12584379 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 100 MG, QD | 200 | MG | Y | 20241 | 100 | MG | QD | ||||
| 125843791 | 12584379 | 2 | C | IMOCLONE | ZOPICLONE | 1 | UNK | U | 0 | ||||||||||
| 125843791 | 12584379 | 3 | C | OXAPAX | OXAZEPAM | 1 | UNK | U | 0 | ||||||||||
| 125843791 | 12584379 | 4 | C | QUETIAPINE. | QUETIAPINE | 1 | UNK | U | 0 | ||||||||||
| 125843791 | 12584379 | 5 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125843791 | 12584379 | 1 | Epilepsy |
| 125843791 | 12584379 | 2 | Product used for unknown indication |
| 125843791 | 12584379 | 3 | Product used for unknown indication |
| 125843791 | 12584379 | 4 | Product used for unknown indication |
| 125843791 | 12584379 | 5 | Depression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125843791 | 12584379 | OT |
| 125843791 | 12584379 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125843791 | 12584379 | Lip erosion | |
| 125843791 | 12584379 | Lip ulceration | |
| 125843791 | 12584379 | Mouth swelling | |
| 125843791 | 12584379 | Mucosal ulceration | |
| 125843791 | 12584379 | Nasal mucosal erosion | |
| 125843791 | 12584379 | Oral mucosa erosion | |
| 125843791 | 12584379 | Pain | |
| 125843791 | 12584379 | Stevens-Johnson syndrome |
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 |
|---|---|---|---|---|---|---|
| 125843791 | 12584379 | 1 | 20160522 | 20160524 | 0 |