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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125619273 | 12561927 | 3 | F | 2010 | 20160901 | 20160715 | 20160909 | EXP | US-JAZZ-2016-US-012790 | JAZZ | 50.33 | YR | F | Y | 0.00000 | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125619273 | 12561927 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2 G, BID | U | 21196 | 2 | G | ORAL SOLUTION | ||||||
| 125619273 | 12561927 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 125619273 | 12561927 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 125619273 | 12561927 | 4 | SS | VITAMIN C | ASCORBIC ACID | 1 | U | 0 | |||||||||||
| 125619273 | 12561927 | 5 | C | CLONAZEPAM. | CLONAZEPAM | 1 | 2 MG, UNK | U | 0 | 2 | MG | TABLET | |||||||
| 125619273 | 12561927 | 6 | C | CLONAZEPAM. | CLONAZEPAM | 1 | 0.5 MG, UNK | U | 0 | .5 | MG | TABLET | |||||||
| 125619273 | 12561927 | 7 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125619273 | 12561927 | 8 | C | ORENCIA | ABATACEPT | 1 | UNK | U | 0 | ||||||||||
| 125619273 | 12561927 | 9 | C | Vitamin c tr | 2 | UNK | U | 0 | TABLET | ||||||||||
| 125619273 | 12561927 | 10 | C | Aspirin ec | ASPIRIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125619273 | 12561927 | 11 | C | COREG | CARVEDILOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125619273 | 12561927 | 12 | C | EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125619273 | 12561927 | 13 | C | HUMALOG | INSULIN LISPRO | 1 | UNK | U | 0 | ||||||||||
| 125619273 | 12561927 | 14 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125619273 | 12561927 | 15 | C | LAMICTAL | LAMOTRIGINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125619273 | 12561927 | 16 | C | LEVOXYL | LEVOTHYROXINE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125619273 | 12561927 | 17 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125619273 | 12561927 | 18 | C | LOVAZA | OMEGA-3-ACID ETHYL ESTERS | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125619273 | 12561927 | 19 | C | PLAVIX | CLOPIDOGREL BISULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125619273 | 12561927 | 20 | C | ROBAXIN | METHOCARBAMOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125619273 | 12561927 | 21 | C | BACTRIM DS | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125619273 | 12561927 | 22 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125619273 | 12561927 | 23 | C | ARAVA | LEFLUNOMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125619273 | 12561927 | 24 | C | METHOTREXATE. | METHOTREXATE | 1 | UNK | U | 0 | ||||||||||
| 125619273 | 12561927 | 25 | C | Hydrocodone/acetaminophen | ACETAMINOPHENHYDROCODONE | 1 | UNK | U | 0 | ||||||||||
| 125619273 | 12561927 | 26 | C | LOSARTAN POTASSIUM. | LOSARTAN POTASSIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125619273 | 12561927 | 27 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125619273 | 12561927 | 28 | C | ENBREL | ETANERCEPT | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125619273 | 12561927 | 1 | Narcolepsy |
| 125619273 | 12561927 | 2 | Cataplexy |
| 125619273 | 12561927 | 4 | Product used for unknown indication |
| 125619273 | 12561927 | 5 | Product used for unknown indication |
| 125619273 | 12561927 | 7 | Product used for unknown indication |
| 125619273 | 12561927 | 8 | Product used for unknown indication |
| 125619273 | 12561927 | 9 | Product used for unknown indication |
| 125619273 | 12561927 | 10 | Product used for unknown indication |
| 125619273 | 12561927 | 11 | Product used for unknown indication |
| 125619273 | 12561927 | 12 | Product used for unknown indication |
| 125619273 | 12561927 | 13 | Product used for unknown indication |
| 125619273 | 12561927 | 14 | Product used for unknown indication |
| 125619273 | 12561927 | 15 | Product used for unknown indication |
| 125619273 | 12561927 | 16 | Product used for unknown indication |
| 125619273 | 12561927 | 17 | Product used for unknown indication |
| 125619273 | 12561927 | 18 | Product used for unknown indication |
| 125619273 | 12561927 | 19 | Product used for unknown indication |
| 125619273 | 12561927 | 20 | Product used for unknown indication |
| 125619273 | 12561927 | 21 | Product used for unknown indication |
| 125619273 | 12561927 | 22 | Product used for unknown indication |
| 125619273 | 12561927 | 23 | Product used for unknown indication |
| 125619273 | 12561927 | 24 | Product used for unknown indication |
| 125619273 | 12561927 | 25 | Product used for unknown indication |
| 125619273 | 12561927 | 26 | Product used for unknown indication |
| 125619273 | 12561927 | 27 | Product used for unknown indication |
| 125619273 | 12561927 | 28 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125619273 | 12561927 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125619273 | 12561927 | Abdominal discomfort | |
| 125619273 | 12561927 | Arthralgia | |
| 125619273 | 12561927 | Bladder disorder | |
| 125619273 | 12561927 | Blood triglycerides increased | |
| 125619273 | 12561927 | Condition aggravated | |
| 125619273 | 12561927 | Depression | |
| 125619273 | 12561927 | Diarrhoea | |
| 125619273 | 12561927 | Fall | |
| 125619273 | 12561927 | Intervertebral disc protrusion | |
| 125619273 | 12561927 | Juvenile idiopathic arthritis | |
| 125619273 | 12561927 | Muscle atrophy | |
| 125619273 | 12561927 | Muscle spasms | |
| 125619273 | 12561927 | Pain in extremity | |
| 125619273 | 12561927 | Spinal column stenosis | |
| 125619273 | 12561927 | 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 |
|---|---|---|---|---|---|---|
| 125619273 | 12561927 | 1 | 200506 | 200506 | 0 | |
| 125619273 | 12561927 | 2 | 200506 | 200511 | 0 | |
| 125619273 | 12561927 | 3 | 200511 | 0 | ||
| 125619273 | 12561927 | 5 | 20160113 | 0 | ||
| 125619273 | 12561927 | 6 | 20140505 | 20160113 | 0 | |
| 125619273 | 12561927 | 7 | 20160113 | 0 | ||
| 125619273 | 12561927 | 8 | 20151020 | 0 | ||
| 125619273 | 12561927 | 9 | 20151020 | 0 | ||
| 125619273 | 12561927 | 10 | 20151008 | 0 | ||
| 125619273 | 12561927 | 11 | 20151008 | 0 | ||
| 125619273 | 12561927 | 12 | 20151008 | 0 | ||
| 125619273 | 12561927 | 13 | 20151008 | 0 | ||
| 125619273 | 12561927 | 14 | 20151008 | 0 | ||
| 125619273 | 12561927 | 15 | 20151008 | 0 | ||
| 125619273 | 12561927 | 16 | 20151008 | 0 | ||
| 125619273 | 12561927 | 17 | 20151008 | 20160113 | 0 | |
| 125619273 | 12561927 | 18 | 20151008 | 0 | ||
| 125619273 | 12561927 | 19 | 20151008 | 0 | ||
| 125619273 | 12561927 | 20 | 20151008 | 0 | ||
| 125619273 | 12561927 | 21 | 20150915 | 20150918 | 0 | |
| 125619273 | 12561927 | 22 | 20150915 | 20150929 | 0 | |
| 125619273 | 12561927 | 23 | 20150101 | 0 | ||
| 125619273 | 12561927 | 24 | 20150101 | 20150915 | 0 | |
| 125619273 | 12561927 | 25 | 20141210 | 20151020 | 0 | |
| 125619273 | 12561927 | 26 | 20140602 | 0 | ||
| 125619273 | 12561927 | 27 | 20130228 | 0 | ||
| 125619273 | 12561927 | 28 | 201501 | 20150915 | 0 |