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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122798604 | 12279860 | 4 | F | 2016 | 20160804 | 20160418 | 20160812 | EXP | US-JAZZ-2016-US-006894 | JAZZ | 0.00 | F | Y | 0.00000 | 20160812 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122798604 | 12279860 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 122798604 | 12279860 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 122798604 | 12279860 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 122798604 | 12279860 | 4 | SS | VITAMIN B12 | CYANOCOBALAMIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 122798604 | 12279860 | 5 | C | Aspirin e.c | ASPIRIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 122798604 | 12279860 | 6 | C | Calcium with Vitamin D | CALCIUMVITAMIN D | 1 | UNK | U | 0 | TABLET | |||||||||
| 122798604 | 12279860 | 7 | C | Clonidine hcl | CLONIDINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 122798604 | 12279860 | 8 | C | CYANOCOBALAMIN. | CYANOCOBALAMIN | 1 | UNK | U | 0 | ||||||||||
| 122798604 | 12279860 | 9 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 122798604 | 12279860 | 10 | C | NIFEDIPINE. | NIFEDIPINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 122798604 | 12279860 | 11 | C | PROMETHAZINE | PROMETHAZINEPROMETHAZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 122798604 | 12279860 | 12 | C | BACLOFEN. | BACLOFEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 122798604 | 12279860 | 13 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | 0 | CAPSULE | ||||||||||
| 122798604 | 12279860 | 14 | C | SIMVASTATIN. | SIMVASTATIN | 1 | UNK | 0 | TABLET | ||||||||||
| 122798604 | 12279860 | 15 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | UNK | 0 | TABLET | ||||||||||
| 122798604 | 12279860 | 16 | C | Terbinafine Hcl | TERBINAFINE HYDROCHLORIDE | 1 | UNK | 0 | POWDER | ||||||||||
| 122798604 | 12279860 | 17 | C | CALCIFEROL | ERGOCALCIFEROL | 1 | U | 0 | DROP | ||||||||||
| 122798604 | 12279860 | 18 | C | Propranolol er | 2 | U | 0 | CAPSULE | |||||||||||
| 122798604 | 12279860 | 19 | C | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122798604 | 12279860 | 1 | Narcolepsy |
| 122798604 | 12279860 | 4 | Product used for unknown indication |
| 122798604 | 12279860 | 5 | Product used for unknown indication |
| 122798604 | 12279860 | 6 | Product used for unknown indication |
| 122798604 | 12279860 | 7 | Product used for unknown indication |
| 122798604 | 12279860 | 8 | Product used for unknown indication |
| 122798604 | 12279860 | 9 | Product used for unknown indication |
| 122798604 | 12279860 | 10 | Product used for unknown indication |
| 122798604 | 12279860 | 11 | Product used for unknown indication |
| 122798604 | 12279860 | 12 | Product used for unknown indication |
| 122798604 | 12279860 | 13 | Product used for unknown indication |
| 122798604 | 12279860 | 14 | Product used for unknown indication |
| 122798604 | 12279860 | 15 | Product used for unknown indication |
| 122798604 | 12279860 | 16 | Product used for unknown indication |
| 122798604 | 12279860 | 17 | Product used for unknown indication |
| 122798604 | 12279860 | 18 | Product used for unknown indication |
| 122798604 | 12279860 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122798604 | 12279860 | OT |
| 122798604 | 12279860 | LT |
| 122798604 | 12279860 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122798604 | 12279860 | Anxiety | |
| 122798604 | 12279860 | Blood parathyroid hormone decreased | |
| 122798604 | 12279860 | Bursitis | |
| 122798604 | 12279860 | Carpal tunnel syndrome | |
| 122798604 | 12279860 | Influenza | |
| 122798604 | 12279860 | Intervertebral disc degeneration | |
| 122798604 | 12279860 | Malaise | |
| 122798604 | 12279860 | Nausea | |
| 122798604 | 12279860 | Nephrolithiasis | |
| 122798604 | 12279860 | Pneumonia | |
| 122798604 | 12279860 | Post-traumatic stress disorder | |
| 122798604 | 12279860 | Psychotic disorder | |
| 122798604 | 12279860 | Respiratory distress | |
| 122798604 | 12279860 | Restless legs syndrome | |
| 122798604 | 12279860 | Sepsis | |
| 122798604 | 12279860 | Stress urinary incontinence | |
| 122798604 | 12279860 | Temporomandibular joint syndrome | |
| 122798604 | 12279860 | Unevaluable event | |
| 122798604 | 12279860 | 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 |
|---|---|---|---|---|---|---|
| 122798604 | 12279860 | 1 | 201103 | 201104 | 0 | |
| 122798604 | 12279860 | 2 | 2011 | 2012 | 0 | |
| 122798604 | 12279860 | 3 | 201201 | 0 | ||
| 122798604 | 12279860 | 4 | 20150101 | 20160114 | 0 | |
| 122798604 | 12279860 | 5 | 20160114 | 0 | ||
| 122798604 | 12279860 | 6 | 20160114 | 0 | ||
| 122798604 | 12279860 | 7 | 20160114 | 0 | ||
| 122798604 | 12279860 | 8 | 20160114 | 0 | ||
| 122798604 | 12279860 | 9 | 20160114 | 0 | ||
| 122798604 | 12279860 | 10 | 20160114 | 0 | ||
| 122798604 | 12279860 | 11 | 20160114 | 0 | ||
| 122798604 | 12279860 | 12 | 20150101 | 0 | ||
| 122798604 | 12279860 | 13 | 20150101 | 20160114 | 0 | |
| 122798604 | 12279860 | 14 | 20150101 | 20160114 | 0 | |
| 122798604 | 12279860 | 15 | 20150101 | 20160114 | 0 | |
| 122798604 | 12279860 | 16 | 20150101 | 20160114 | 0 |