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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126087754 | 12608775 | 4 | F | 2016 | 20160921 | 20160729 | 20160929 | EXP | US-JAZZ-2016-US-013803 | JAZZ | 34.62 | YR | F | Y | 0.00000 | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126087754 | 12608775 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126087754 | 12608775 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 126087754 | 12608775 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 126087754 | 12608775 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 126087754 | 12608775 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 126087754 | 12608775 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 126087754 | 12608775 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 126087754 | 12608775 | 8 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, FIRST DOSE | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 126087754 | 12608775 | 9 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, SECOND DOSE | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 126087754 | 12608775 | 10 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 126087754 | 12608775 | 11 | SS | CIPROFLOXACIN HYDROCHLORIDE. | CIPROFLOXACIN HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126087754 | 12608775 | 12 | SS | LAMICTAL | LAMOTRIGINE | 1 | Y | 0 | |||||||||||
| 126087754 | 12608775 | 13 | SS | KEPPRA | LEVETIRACETAM | 1 | Y | 0 | |||||||||||
| 126087754 | 12608775 | 14 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126087754 | 12608775 | 15 | C | MELOXICAM. | MELOXICAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 126087754 | 12608775 | 16 | C | TYLENOL ARTHRITIS PAIN | ACETAMINOPHEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 126087754 | 12608775 | 17 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 126087754 | 12608775 | 18 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 126087754 | 12608775 | 19 | C | Calcium | CALCIUM | 1 | U | 0 | TABLET | ||||||||||
| 126087754 | 12608775 | 20 | C | CLARITIN | LORATADINE | 1 | U | 0 | |||||||||||
| 126087754 | 12608775 | 21 | C | KLONOPIN | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 126087754 | 12608775 | 22 | C | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | U | 0 | CAPSULE | ||||||||||
| 126087754 | 12608775 | 23 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | U | 0 | TABLET | ||||||||||
| 126087754 | 12608775 | 24 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126087754 | 12608775 | 1 | Narcolepsy |
| 126087754 | 12608775 | 2 | Cataplexy |
| 126087754 | 12608775 | 11 | Kidney infection |
| 126087754 | 12608775 | 12 | Product used for unknown indication |
| 126087754 | 12608775 | 13 | Product used for unknown indication |
| 126087754 | 12608775 | 14 | Product used for unknown indication |
| 126087754 | 12608775 | 15 | Product used for unknown indication |
| 126087754 | 12608775 | 16 | Product used for unknown indication |
| 126087754 | 12608775 | 17 | Product used for unknown indication |
| 126087754 | 12608775 | 18 | Product used for unknown indication |
| 126087754 | 12608775 | 19 | Product used for unknown indication |
| 126087754 | 12608775 | 20 | Product used for unknown indication |
| 126087754 | 12608775 | 21 | Product used for unknown indication |
| 126087754 | 12608775 | 22 | Product used for unknown indication |
| 126087754 | 12608775 | 23 | Product used for unknown indication |
| 126087754 | 12608775 | 24 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126087754 | 12608775 | HO |
| 126087754 | 12608775 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126087754 | 12608775 | Confusional state | |
| 126087754 | 12608775 | Dehydration | |
| 126087754 | 12608775 | Feeling abnormal | |
| 126087754 | 12608775 | Hallucination | |
| 126087754 | 12608775 | Kidney infection | |
| 126087754 | 12608775 | Malaise | |
| 126087754 | 12608775 | Memory impairment | |
| 126087754 | 12608775 | Mood altered | |
| 126087754 | 12608775 | Seizure |
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 |
|---|---|---|---|---|---|---|
| 126087754 | 12608775 | 1 | 201002 | 201003 | 0 | |
| 126087754 | 12608775 | 2 | 201003 | 2011 | 0 | |
| 126087754 | 12608775 | 3 | 201202 | 2012 | 0 | |
| 126087754 | 12608775 | 4 | 201311 | 2013 | 0 | |
| 126087754 | 12608775 | 5 | 201406 | 2014 | 0 | |
| 126087754 | 12608775 | 6 | 201502 | 2015 | 0 | |
| 126087754 | 12608775 | 7 | 201602 | 201604 | 0 | |
| 126087754 | 12608775 | 8 | 201604 | 2016 | 0 | |
| 126087754 | 12608775 | 9 | 201604 | 2016 | 0 | |
| 126087754 | 12608775 | 10 | 201607 | 0 | ||
| 126087754 | 12608775 | 14 | 20160622 | 0 | ||
| 126087754 | 12608775 | 15 | 201602 | 0 | ||
| 126087754 | 12608775 | 16 | 201602 | 0 | ||
| 126087754 | 12608775 | 17 | 201602 | 0 | ||
| 126087754 | 12608775 | 18 | 20160111 | 0 | ||
| 126087754 | 12608775 | 21 | 20160706 | 0 |