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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127144591 | 12714459 | 1 | I | 20160510 | 20160511 | 20160905 | 20160905 | PER | US-JAZZ-2016-US-008913 | JAZZ | 50.90 | YR | F | Y | 0.00000 | 20160905 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127144591 | 12714459 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 127144591 | 12714459 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127144591 | 12714459 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, TID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127144591 | 12714459 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127144591 | 12714459 | 5 | SS | TRAZODONE HYDROCHLORIDE. | TRAZODONE HYDROCHLORIDE | 1 | 50 MG | U | 0 | 50 | MG | TABLET | |||||||
| 127144591 | 12714459 | 6 | C | TROKENDI XR | TOPIRAMATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127144591 | 12714459 | 7 | C | BOTOX | ONABOTULINUMTOXINA | 1 | UNK | U | 0 | ||||||||||
| 127144591 | 12714459 | 8 | C | MAXALT | RIZATRIPTAN BENZOATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144591 | 12714459 | 9 | C | Naltrexone hcl | NALTREXONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144591 | 12714459 | 10 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144591 | 12714459 | 11 | C | INDOMETHACIN. | INDOMETHACIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127144591 | 12714459 | 12 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144591 | 12714459 | 13 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144591 | 12714459 | 14 | C | Calcium | CALCIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144591 | 12714459 | 15 | C | Fish oil concentrate | 2 | UNK | U | 0 | |||||||||||
| 127144591 | 12714459 | 16 | C | KETOROLAC | KETOROLACKETOROLAC TROMETHAMINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144591 | 12714459 | 17 | C | L-carnitine | LEVOCARNITINE | 1 | UNK | U | 0 | POWDER | |||||||||
| 127144591 | 12714459 | 18 | C | Magnesium carbonate | MAGNESIUM CARBONATE | 1 | UNK | U | 0 | POWDER | |||||||||
| 127144591 | 12714459 | 19 | C | Melatonin | MELATONIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144591 | 12714459 | 20 | C | Multivitamin | VITAMINS | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127144591 | 12714459 | 21 | C | Turmeric | TURMERIC | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127144591 | 12714459 | 22 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144591 | 12714459 | 23 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 127144591 | 12714459 | 24 | C | CELEXA | CITALOPRAM HYDROBROMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144591 | 12714459 | 25 | C | LYRICA | PREGABALIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127144591 | 12714459 | 26 | C | CLARITIN | LORATADINE | 1 | U | 0 | CAPSULE | ||||||||||
| 127144591 | 12714459 | 27 | C | IBUPROFEN. | IBUPROFEN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127144591 | 12714459 | 1 | Narcolepsy |
| 127144591 | 12714459 | 2 | Cataplexy |
| 127144591 | 12714459 | 5 | Product used for unknown indication |
| 127144591 | 12714459 | 6 | Product used for unknown indication |
| 127144591 | 12714459 | 7 | Product used for unknown indication |
| 127144591 | 12714459 | 8 | Product used for unknown indication |
| 127144591 | 12714459 | 9 | Product used for unknown indication |
| 127144591 | 12714459 | 10 | Product used for unknown indication |
| 127144591 | 12714459 | 11 | Product used for unknown indication |
| 127144591 | 12714459 | 12 | Product used for unknown indication |
| 127144591 | 12714459 | 13 | Product used for unknown indication |
| 127144591 | 12714459 | 14 | Product used for unknown indication |
| 127144591 | 12714459 | 15 | Product used for unknown indication |
| 127144591 | 12714459 | 16 | Product used for unknown indication |
| 127144591 | 12714459 | 17 | Product used for unknown indication |
| 127144591 | 12714459 | 18 | Product used for unknown indication |
| 127144591 | 12714459 | 19 | Product used for unknown indication |
| 127144591 | 12714459 | 20 | Product used for unknown indication |
| 127144591 | 12714459 | 21 | Product used for unknown indication |
| 127144591 | 12714459 | 22 | Product used for unknown indication |
| 127144591 | 12714459 | 23 | Product used for unknown indication |
| 127144591 | 12714459 | 24 | Product used for unknown indication |
| 127144591 | 12714459 | 25 | Product used for unknown indication |
| 127144591 | 12714459 | 26 | Product used for unknown indication |
| 127144591 | 12714459 | 27 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127144591 | 12714459 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127144591 | 12714459 | Dry mouth | |
| 127144591 | 12714459 | Incorrect dose administered | |
| 127144591 | 12714459 | Migraine | |
| 127144591 | 12714459 | Sleep apnoea syndrome |
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 |
|---|---|---|---|---|---|---|
| 127144591 | 12714459 | 1 | 201405 | 201405 | 0 | |
| 127144591 | 12714459 | 2 | 201405 | 201601 | 0 | |
| 127144591 | 12714459 | 3 | 201601 | 2016 | 0 | |
| 127144591 | 12714459 | 4 | 2016 | 201605 | 0 | |
| 127144591 | 12714459 | 6 | 201605 | 0 | ||
| 127144591 | 12714459 | 7 | 20151125 | 0 | ||
| 127144591 | 12714459 | 8 | 20151125 | 0 | ||
| 127144591 | 12714459 | 9 | 20151113 | 20151113 | 0 | |
| 127144591 | 12714459 | 10 | 20150327 | 201604 | 0 | |
| 127144591 | 12714459 | 11 | 20141231 | 20151111 | 0 | |
| 127144591 | 12714459 | 12 | 20141231 | 0 | ||
| 127144591 | 12714459 | 13 | 20141001 | 20151111 | 0 | |
| 127144591 | 12714459 | 14 | 20140512 | 0 | ||
| 127144591 | 12714459 | 15 | 20140512 | 201509 | 0 | |
| 127144591 | 12714459 | 16 | 20140512 | 20151111 | 0 | |
| 127144591 | 12714459 | 17 | 20140512 | 0 | ||
| 127144591 | 12714459 | 18 | 20140512 | 0 | ||
| 127144591 | 12714459 | 19 | 20140512 | 201506 | 0 | |
| 127144591 | 12714459 | 20 | 20140512 | 0 | ||
| 127144591 | 12714459 | 21 | 20140512 | 201507 | 0 | |
| 127144591 | 12714459 | 22 | 20140512 | 0 | ||
| 127144591 | 12714459 | 23 | 20140512 | 0 | ||
| 127144591 | 12714459 | 24 | 20131201 | 20141230 | 0 | |
| 127144591 | 12714459 | 25 | 20120101 | 0 |