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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125371311 | 12537131 | 1 | I | 201510 | 20151228 | 20160707 | 20160707 | PER | US-JAZZ-2015-US-022544 | JAZZ | 63.40 | YR | M | Y | 89.34000 | KG | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125371311 | 12537131 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125371311 | 12537131 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125371311 | 12537131 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 125371311 | 12537131 | 4 | C | DULOXETINE. | DULOXETINE | 1 | UNK, QD | U | 0 | ||||||||||
| 125371311 | 12537131 | 5 | C | ESCITALOPRAM | ESCITALOPRAM OXALATE | 1 | UNK, QD | U | 0 | TABLET | |||||||||
| 125371311 | 12537131 | 6 | C | MELOXICAM. | MELOXICAM | 1 | UNK, QD | U | 0 | TABLET | |||||||||
| 125371311 | 12537131 | 7 | C | MELOXICAM. | MELOXICAM | 1 | U | 0 | TABLET | ||||||||||
| 125371311 | 12537131 | 8 | C | Multivitamins | VITAMINS | 1 | UNK, QD | U | 0 | CAPSULE | |||||||||
| 125371311 | 12537131 | 9 | C | NUVIGIL | ARMODAFINIL | 1 | UNK, QD | U | 0 | TABLET | |||||||||
| 125371311 | 12537131 | 10 | C | Tylenol arthritis er | 2 | UNK, PRN | U | 0 | TABLET | ||||||||||
| 125371311 | 12537131 | 11 | C | Tylenol arthritis er | 2 | U | 0 | TABLET | |||||||||||
| 125371311 | 12537131 | 12 | C | Tylenol arthritis er | 2 | U | 0 | TABLET | |||||||||||
| 125371311 | 12537131 | 13 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125371311 | 12537131 | 14 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125371311 | 12537131 | 15 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125371311 | 12537131 | 16 | C | LYRICA | PREGABALIN | 1 | UNK | U | 0 | ||||||||||
| 125371311 | 12537131 | 17 | C | Tolterodine tartra er | 2 | UNK | U | 0 | CAPSULE | ||||||||||
| 125371311 | 12537131 | 18 | C | CIALIS | TADALAFIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125371311 | 12537131 | 19 | C | PANTOPRAZOLE SODIUM DR | PANTOPRAZOLE SODIUM | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125371311 | 12537131 | 1 | Narcolepsy |
| 125371311 | 12537131 | 2 | Somnolence |
| 125371311 | 12537131 | 4 | Back pain |
| 125371311 | 12537131 | 5 | Depression |
| 125371311 | 12537131 | 6 | Back pain |
| 125371311 | 12537131 | 7 | Repetitive strain injury |
| 125371311 | 12537131 | 8 | Supplementation therapy |
| 125371311 | 12537131 | 9 | Narcolepsy |
| 125371311 | 12537131 | 10 | Arthritis |
| 125371311 | 12537131 | 11 | Arthralgia |
| 125371311 | 12537131 | 12 | Back pain |
| 125371311 | 12537131 | 13 | Product used for unknown indication |
| 125371311 | 12537131 | 14 | Product used for unknown indication |
| 125371311 | 12537131 | 15 | Product used for unknown indication |
| 125371311 | 12537131 | 16 | Product used for unknown indication |
| 125371311 | 12537131 | 17 | Product used for unknown indication |
| 125371311 | 12537131 | 18 | Product used for unknown indication |
| 125371311 | 12537131 | 19 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125371311 | 12537131 | Chest discomfort | |
| 125371311 | 12537131 | Dyspnoea | |
| 125371311 | 12537131 | Headache | |
| 125371311 | 12537131 | Hernia | |
| 125371311 | 12537131 | Insomnia | |
| 125371311 | 12537131 | Nasopharyngitis | |
| 125371311 | 12537131 | Pain | |
| 125371311 | 12537131 | Paranasal sinus hypersecretion | |
| 125371311 | 12537131 | 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 |
|---|---|---|---|---|---|---|
| 125371311 | 12537131 | 1 | 201408 | 201409 | 0 | |
| 125371311 | 12537131 | 2 | 2014 | 2014 | 0 | |
| 125371311 | 12537131 | 3 | 201409 | 0 | ||
| 125371311 | 12537131 | 5 | 20140924 | 0 | ||
| 125371311 | 12537131 | 6 | 20140820 | 0 | ||
| 125371311 | 12537131 | 8 | 20140820 | 0 | ||
| 125371311 | 12537131 | 10 | 20140820 | 0 | ||
| 125371311 | 12537131 | 13 | 20150708 | 0 | ||
| 125371311 | 12537131 | 14 | 20150105 | 0 | ||
| 125371311 | 12537131 | 15 | 20141125 | 20150105 | 0 | |
| 125371311 | 12537131 | 16 | 20140828 | 20141125 | 0 | |
| 125371311 | 12537131 | 17 | 20140922 | 0 | ||
| 125371311 | 12537131 | 18 | 20140917 | 0 | ||
| 125371311 | 12537131 | 19 | 20140820 | 0 |