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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125215121 | 12521512 | 1 | I | 2002 | 20160623 | 20160701 | 20160701 | EXP | US-JAZZ-2016-US-011887 | JAZZ | 0.00 | F | Y | 0.00000 | 20160701 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125215121 | 12521512 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.5 G, BID | U | 21196 | 1.5 | G | ORAL SOLUTION | ||||||
| 125215121 | 12521512 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 125215121 | 12521512 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 125215121 | 12521512 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 125215121 | 12521512 | 5 | C | NIACIN. | NIACIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125215121 | 12521512 | 6 | C | OCUVITE | VITAMINS | 1 | UNK | U | 0 | ||||||||||
| 125215121 | 12521512 | 7 | C | PROGESTERONE. | PROGESTERONE | 1 | UNK | U | 0 | CREAM | |||||||||
| 125215121 | 12521512 | 8 | C | Biotin | BIOTIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125215121 | 12521512 | 9 | C | Coq10 | UBIDECARENONE | 1 | UNK | U | 0 | ||||||||||
| 125215121 | 12521512 | 10 | C | Fish oil concentrate | 2 | UNK | U | 0 | |||||||||||
| 125215121 | 12521512 | 11 | C | FLAXSEED | FLAX SEED | 1 | UNK | U | 0 | POWDER | |||||||||
| 125215121 | 12521512 | 12 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125215121 | 12521512 | 13 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | UNK | U | 0 | POWDER | |||||||||
| 125215121 | 12521512 | 14 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125215121 | 12521512 | 15 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125215121 | 12521512 | 16 | C | RITALIN LA | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125215121 | 12521512 | 17 | C | RITALIN LA | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125215121 | 12521512 | 18 | C | VITAMIN C | ASCORBIC ACID | 1 | UNK | U | 0 | ||||||||||
| 125215121 | 12521512 | 19 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | ||||||||||
| 125215121 | 12521512 | 20 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125215121 | 12521512 | 21 | C | Calcium +D | CALCIUMVITAMIN D | 1 | U | 0 | |||||||||||
| 125215121 | 12521512 | 22 | C | CYTOMEL | LIOTHYRONINE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125215121 | 12521512 | 23 | C | ESTRACE | ESTRADIOL | 1 | UNK | U | 0 | CREAM | |||||||||
| 125215121 | 12521512 | 24 | C | Fish oil | FISH OIL | 1 | UNK | U | 0 | ||||||||||
| 125215121 | 12521512 | 25 | C | MAGNESIUM OXIDE. | MAGNESIUM OXIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125215121 | 12521512 | 26 | C | MIACALCIN | CALCITONIN SALMON | 1 | UNK | U | 0 | NASAL SPRAY | |||||||||
| 125215121 | 12521512 | 27 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125215121 | 12521512 | 28 | C | VITAMIN C | ASCORBIC ACID | 1 | U | 0 | TABLET | ||||||||||
| 125215121 | 12521512 | 29 | C | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 | TABLET | ||||||||||
| 125215121 | 12521512 | 30 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125215121 | 12521512 | 1 | Narcolepsy |
| 125215121 | 12521512 | 2 | Cataplexy |
| 125215121 | 12521512 | 5 | Product used for unknown indication |
| 125215121 | 12521512 | 6 | Product used for unknown indication |
| 125215121 | 12521512 | 7 | Product used for unknown indication |
| 125215121 | 12521512 | 8 | Product used for unknown indication |
| 125215121 | 12521512 | 9 | Product used for unknown indication |
| 125215121 | 12521512 | 10 | Product used for unknown indication |
| 125215121 | 12521512 | 11 | Product used for unknown indication |
| 125215121 | 12521512 | 12 | Product used for unknown indication |
| 125215121 | 12521512 | 13 | Product used for unknown indication |
| 125215121 | 12521512 | 14 | Product used for unknown indication |
| 125215121 | 12521512 | 16 | Product used for unknown indication |
| 125215121 | 12521512 | 18 | Product used for unknown indication |
| 125215121 | 12521512 | 19 | Product used for unknown indication |
| 125215121 | 12521512 | 20 | Product used for unknown indication |
| 125215121 | 12521512 | 21 | Product used for unknown indication |
| 125215121 | 12521512 | 22 | Product used for unknown indication |
| 125215121 | 12521512 | 23 | Product used for unknown indication |
| 125215121 | 12521512 | 24 | Product used for unknown indication |
| 125215121 | 12521512 | 25 | Product used for unknown indication |
| 125215121 | 12521512 | 26 | Product used for unknown indication |
| 125215121 | 12521512 | 27 | Product used for unknown indication |
| 125215121 | 12521512 | 28 | Product used for unknown indication |
| 125215121 | 12521512 | 29 | Product used for unknown indication |
| 125215121 | 12521512 | 30 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125215121 | 12521512 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125215121 | 12521512 | Bladder disorder | |
| 125215121 | 12521512 | Blood pressure abnormal | |
| 125215121 | 12521512 | Fall | |
| 125215121 | 12521512 | Somnambulism | |
| 125215121 | 12521512 | Somnolence | |
| 125215121 | 12521512 | Therapeutic response unexpected | |
| 125215121 | 12521512 | Tumour excision |
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 |
|---|---|---|---|---|---|---|
| 125215121 | 12521512 | 1 | 200210 | 2003 | 0 | |
| 125215121 | 12521512 | 2 | 201503 | 201504 | 0 | |
| 125215121 | 12521512 | 3 | 201504 | 201509 | 0 | |
| 125215121 | 12521512 | 4 | 201509 | 0 | ||
| 125215121 | 12521512 | 5 | 20150407 | 20150407 | 0 | |
| 125215121 | 12521512 | 6 | 20150407 | 0 | ||
| 125215121 | 12521512 | 7 | 20150407 | 201605 | 0 | |
| 125215121 | 12521512 | 8 | 20150323 | 201506 | 0 | |
| 125215121 | 12521512 | 9 | 20150323 | 0 | ||
| 125215121 | 12521512 | 10 | 20150323 | 0 | ||
| 125215121 | 12521512 | 11 | 20150323 | 0 | ||
| 125215121 | 12521512 | 12 | 20150323 | 0 | ||
| 125215121 | 12521512 | 13 | 20150323 | 0 | ||
| 125215121 | 12521512 | 14 | 20150323 | 0 | ||
| 125215121 | 12521512 | 15 | 20160623 | 0 | ||
| 125215121 | 12521512 | 16 | 20150323 | 0 | ||
| 125215121 | 12521512 | 17 | 20160623 | 0 | ||
| 125215121 | 12521512 | 18 | 20150323 | 20150406 | 0 | |
| 125215121 | 12521512 | 19 | 20150323 | 0 | ||
| 125215121 | 12521512 | 20 | 20150323 | 0 | ||
| 125215121 | 12521512 | 22 | 201412 | 0 | ||
| 125215121 | 12521512 | 23 | 20160623 | 0 | ||
| 125215121 | 12521512 | 24 | 20160623 | 0 | ||
| 125215121 | 12521512 | 25 | 20160623 | 0 | ||
| 125215121 | 12521512 | 26 | 201012 | 0 | ||
| 125215121 | 12521512 | 27 | 20160623 | 0 | ||
| 125215121 | 12521512 | 30 | 20160623 | 0 |