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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124678924 | 12467892 | 4 | F | 201605 | 20160802 | 20160615 | 20160810 | EXP | US-JAZZ-2016-US-010635 | JAZZ | 47.81 | YR | F | Y | 0.00000 | 20160810 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124678924 | 12467892 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 124678924 | 12467892 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 6 G, FIRST DOSE | 21196 | 6 | G | ORAL SOLUTION | |||||||
| 124678924 | 12467892 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, SECOND DOSE | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 124678924 | 12467892 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 124678924 | 12467892 | 5 | SS | Hydroxyzine Hcl | HYDROXYZINE HYDROCHLORIDE | 1 | UNK | N | 0 | TABLET | |||||||||
| 124678924 | 12467892 | 6 | C | ATIVAN | LORAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 124678924 | 12467892 | 7 | C | Fish oil concentrate | 2 | UNK | U | 0 | |||||||||||
| 124678924 | 12467892 | 8 | C | ALPHA LIPOIC ACID | .ALPHA.-LIPOIC ACID | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124678924 | 12467892 | 9 | C | CALCIUM CARBONATE. | CALCIUM CARBONATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124678924 | 12467892 | 10 | C | Coq10 | UBIDECARENONE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124678924 | 12467892 | 11 | C | ESTRADIOL. | ESTRADIOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 124678924 | 12467892 | 12 | C | N-acetyl-l-cysteine | ACETYLCYSTEINE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124678924 | 12467892 | 13 | C | PROGESTERONE. | PROGESTERONE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124678924 | 12467892 | 14 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 124678924 | 12467892 | 15 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124678924 | 12467892 | 16 | C | IBUPROFEN. | IBUPROFEN | 1 | UNK | U | 0 | ||||||||||
| 124678924 | 12467892 | 17 | C | IMITREX | SUMATRIPTAN SUCCINATE | 1 | UNK | U | 0 | ||||||||||
| 124678924 | 12467892 | 18 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124678924 | 12467892 | 19 | C | BOTOX | ONABOTULINUMTOXINA | 1 | U | 0 | |||||||||||
| 124678924 | 12467892 | 20 | C | IMITREX | SUMATRIPTAN SUCCINATE | 1 | U | 0 | TABLET | ||||||||||
| 124678924 | 12467892 | 21 | C | TYLENOL 8 HR | ACETAMINOPHEN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124678924 | 12467892 | 1 | Chronic fatigue syndrome |
| 124678924 | 12467892 | 5 | Product used for unknown indication |
| 124678924 | 12467892 | 6 | Product used for unknown indication |
| 124678924 | 12467892 | 7 | Product used for unknown indication |
| 124678924 | 12467892 | 8 | Product used for unknown indication |
| 124678924 | 12467892 | 9 | Product used for unknown indication |
| 124678924 | 12467892 | 10 | Product used for unknown indication |
| 124678924 | 12467892 | 11 | Product used for unknown indication |
| 124678924 | 12467892 | 12 | Product used for unknown indication |
| 124678924 | 12467892 | 13 | Product used for unknown indication |
| 124678924 | 12467892 | 14 | Product used for unknown indication |
| 124678924 | 12467892 | 15 | Product used for unknown indication |
| 124678924 | 12467892 | 16 | Product used for unknown indication |
| 124678924 | 12467892 | 17 | Product used for unknown indication |
| 124678924 | 12467892 | 18 | Product used for unknown indication |
| 124678924 | 12467892 | 19 | Product used for unknown indication |
| 124678924 | 12467892 | 20 | Product used for unknown indication |
| 124678924 | 12467892 | 21 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124678924 | 12467892 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124678924 | 12467892 | Fatigue | |
| 124678924 | 12467892 | Headache | |
| 124678924 | 12467892 | Insomnia | |
| 124678924 | 12467892 | Migraine | |
| 124678924 | 12467892 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 124678924 | 12467892 | 1 | 201005 | 201109 | 0 | |
| 124678924 | 12467892 | 2 | 201109 | 201201 | 0 | |
| 124678924 | 12467892 | 3 | 201109 | 201201 | 0 | |
| 124678924 | 12467892 | 4 | 201201 | 0 | ||
| 124678924 | 12467892 | 6 | 20160108 | 0 | ||
| 124678924 | 12467892 | 7 | 20160108 | 0 | ||
| 124678924 | 12467892 | 8 | 20150414 | 0 | ||
| 124678924 | 12467892 | 9 | 20150414 | 0 | ||
| 124678924 | 12467892 | 10 | 20150414 | 0 | ||
| 124678924 | 12467892 | 11 | 20150414 | 0 | ||
| 124678924 | 12467892 | 12 | 20150414 | 0 | ||
| 124678924 | 12467892 | 13 | 20150414 | 0 | ||
| 124678924 | 12467892 | 14 | 20150414 | 0 | ||
| 124678924 | 12467892 | 15 | 20130610 | 0 | ||
| 124678924 | 12467892 | 16 | 20130610 | 0 | ||
| 124678924 | 12467892 | 17 | 20130610 | 0 |