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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122650342 | 12265034 | 2 | F | 201511 | 20160824 | 20160413 | 20160831 | EXP | US-JAZZ-2016-US-006524 | JAZZ | 74.57 | YR | F | Y | 0.00000 | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122650342 | 12265034 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 122650342 | 12265034 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 122650342 | 12265034 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 122650342 | 12265034 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.25 G, BID | Y | 21196 | 4.25 | G | ORAL SOLUTION | ||||||
| 122650342 | 12265034 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | 3 G, BID | Y | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 122650342 | 12265034 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | 3.25 G, BID | Y | 21196 | 3.25 | G | ORAL SOLUTION | |||||||
| 122650342 | 12265034 | 7 | C | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | U | 0 | TABLET | ||||||||||
| 122650342 | 12265034 | 8 | C | COENZYME Q10 | UBIDECARENONE | 1 | U | 0 | |||||||||||
| 122650342 | 12265034 | 9 | C | Fluoxetine hcl | FLUOXETINE HYDROCHLORIDE | 1 | UNK | 0 | CAPSULE | ||||||||||
| 122650342 | 12265034 | 10 | C | LOVASTATIN. | LOVASTATIN | 1 | U | 0 | TABLET | ||||||||||
| 122650342 | 12265034 | 11 | C | MODAFINIL. | MODAFINIL | 1 | U | 0 | TABLET | ||||||||||
| 122650342 | 12265034 | 12 | C | OXYBUTYNIN CHLORIDE. | OXYBUTYNIN CHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 122650342 | 12265034 | 13 | C | S-ADENOSYLMETHIONINE SULFATE P-TOLUENESULFONATE | ADEMETIONINE SULFATE TOSILATE | 1 | U | 0 | TABLET | ||||||||||
| 122650342 | 12265034 | 14 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122650342 | 12265034 | 1 | Narcolepsy |
| 122650342 | 12265034 | 2 | Cataplexy |
| 122650342 | 12265034 | 7 | Product used for unknown indication |
| 122650342 | 12265034 | 8 | Product used for unknown indication |
| 122650342 | 12265034 | 9 | Product used for unknown indication |
| 122650342 | 12265034 | 10 | Product used for unknown indication |
| 122650342 | 12265034 | 11 | Product used for unknown indication |
| 122650342 | 12265034 | 12 | Product used for unknown indication |
| 122650342 | 12265034 | 13 | Product used for unknown indication |
| 122650342 | 12265034 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122650342 | 12265034 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122650342 | 12265034 | Blood cholesterol increased | |
| 122650342 | 12265034 | Constipation | |
| 122650342 | 12265034 | Dehydration | |
| 122650342 | 12265034 | Depression | |
| 122650342 | 12265034 | Fatigue | |
| 122650342 | 12265034 | Heart rate decreased | |
| 122650342 | 12265034 | Hypoaesthesia | |
| 122650342 | 12265034 | Incontinence | |
| 122650342 | 12265034 | Osteoarthritis | |
| 122650342 | 12265034 | Osteoporosis | |
| 122650342 | 12265034 | Retching | |
| 122650342 | 12265034 | Sleep apnoea syndrome | |
| 122650342 | 12265034 | Treatment noncompliance | |
| 122650342 | 12265034 | Vomiting | |
| 122650342 | 12265034 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 122650342 | 12265034 | 1 | 200306 | 200312 | 0 | |
| 122650342 | 12265034 | 2 | 2003 | 2012 | 0 | |
| 122650342 | 12265034 | 3 | 201204 | 2015 | 0 | |
| 122650342 | 12265034 | 4 | 201511 | 0 | ||
| 122650342 | 12265034 | 9 | 201603 | 0 | ||
| 122650342 | 12265034 | 14 | 201604 | 0 |