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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124782963 | 12478296 | 3 | F | 20160812 | 20160617 | 20160826 | EXP | US-JAZZ-2016-US-010940 | JAZZ | 0.00 | F | Y | 0.00000 | 20160826 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124782963 | 12478296 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | U | 21196 | 4 | G | ORAL SOLUTION | ||||||
| 124782963 | 12478296 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | U | 21196 | ORAL SOLUTION | ||||||||||
| 124782963 | 12478296 | 3 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124782963 | 12478296 | 4 | C | LYRICA | PREGABALIN | 1 | UNK | U | 0 | ||||||||||
| 124782963 | 12478296 | 5 | C | LYRICA | PREGABALIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124782963 | 12478296 | 6 | C | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 124782963 | 12478296 | 7 | C | NUVIGIL | ARMODAFINIL | 1 | U | 0 | TABLET | ||||||||||
| 124782963 | 12478296 | 8 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | U | 0 | TABLET | ||||||||||
| 124782963 | 12478296 | 9 | C | TOPAMAX | TOPIRAMATE | 1 | U | 0 | TABLET | ||||||||||
| 124782963 | 12478296 | 10 | C | VENTOLIN HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124782963 | 12478296 | 1 | Narcolepsy |
| 124782963 | 12478296 | 2 | Cataplexy |
| 124782963 | 12478296 | 3 | Product used for unknown indication |
| 124782963 | 12478296 | 4 | Product used for unknown indication |
| 124782963 | 12478296 | 5 | Product used for unknown indication |
| 124782963 | 12478296 | 6 | Product used for unknown indication |
| 124782963 | 12478296 | 7 | Product used for unknown indication |
| 124782963 | 12478296 | 8 | Product used for unknown indication |
| 124782963 | 12478296 | 9 | Product used for unknown indication |
| 124782963 | 12478296 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124782963 | 12478296 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124782963 | 12478296 | Abnormal dreams | |
| 124782963 | 12478296 | Gastric banding reversal | |
| 124782963 | 12478296 | Headache | |
| 124782963 | 12478296 | Insomnia | |
| 124782963 | 12478296 | Nephrolithiasis | |
| 124782963 | 12478296 | 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 |
|---|---|---|---|---|---|---|
| 124782963 | 12478296 | 1 | 201603 | 0 | ||
| 124782963 | 12478296 | 3 | 201603 | 0 | ||
| 124782963 | 12478296 | 4 | 201605 | 0 | ||
| 124782963 | 12478296 | 5 | 201603 | 0 |