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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127265671 | 12726567 | 1 | I | 20120801 | 20160906 | 20160908 | 20160908 | PER | US-GLAXOSMITHKLINE-US2016GSK131193 | GLAXOSMITHKLINE | 28.23 | YR | F | Y | 0.00000 | 20160908 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127265671 | 12726567 | 1 | PS | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | U | 18644 | |||||||||||
| 127265671 | 12726567 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 3082257 | 0 | 2.25 | G | BID | |||||
| 127265671 | 12726567 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | 4.25 G, BID | U | 0 | 4.25 | G | BID | |||||||
| 127265671 | 12726567 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | U | 0 | 4 | G | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127265671 | 12726567 | 1 | Product used for unknown indication |
| 127265671 | 12726567 | 2 | Narcolepsy |
| 127265671 | 12726567 | 3 | Cataplexy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127265671 | 12726567 | HO |
| 127265671 | 12726567 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127265671 | 12726567 | Anxiety | |
| 127265671 | 12726567 | Depression | |
| 127265671 | 12726567 | Fall | |
| 127265671 | 12726567 | Insomnia | |
| 127265671 | 12726567 | Suicidal ideation | |
| 127265671 | 12726567 | Unevaluable event |
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 |
|---|---|---|---|---|---|---|
| 127265671 | 12726567 | 2 | 201101 | 2011 | 0 | |
| 127265671 | 12726567 | 3 | 201405 | 20140922 | 0 | |
| 127265671 | 12726567 | 4 | 2014 | 0 |