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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125371841 | 12537184 | 1 | I | 20151230 | 20160707 | 20160707 | PER | US-JAZZ-2015-US-022759 | JAZZ | 0.00 | M | Y | 0.00000 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125371841 | 12537184 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.5 G, BID | 21196 | 1.5 | G | ORAL SOLUTION | |||||||
125371841 | 12537184 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENT | 21196 | ORAL SOLUTION | |||||||||
125371841 | 12537184 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
125371841 | 12537184 | 4 | C | OXCARBAZEPINE. | OXCARBAZEPINE | 1 | UNK | U | 0 | TABLET | |||||||||
125371841 | 12537184 | 5 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
125371841 | 12537184 | 6 | C | ROBAXIN | METHOCARBAMOL | 1 | UNK | U | 0 | TABLET | |||||||||
125371841 | 12537184 | 7 | C | Amitriptyline hcl | AMITRIPTYLINE | 1 | UNK | U | 0 | POWDER | |||||||||
125371841 | 12537184 | 8 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | UNK | U | 0 | TABLET | |||||||||
125371841 | 12537184 | 9 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
125371841 | 12537184 | 10 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
125371841 | 12537184 | 11 | C | LIDOCAINE. | LIDOCAINE | 1 | UNK | U | 0 | POWDER | |||||||||
125371841 | 12537184 | 12 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
125371841 | 12537184 | 13 | C | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
125371841 | 12537184 | 14 | C | Voltaren EC | 2 | UNK | U | 0 | TABLET |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125371841 | 12537184 | 1 | Narcolepsy |
125371841 | 12537184 | 4 | Product used for unknown indication |
125371841 | 12537184 | 5 | Product used for unknown indication |
125371841 | 12537184 | 6 | Product used for unknown indication |
125371841 | 12537184 | 7 | Product used for unknown indication |
125371841 | 12537184 | 8 | Product used for unknown indication |
125371841 | 12537184 | 9 | Product used for unknown indication |
125371841 | 12537184 | 10 | Product used for unknown indication |
125371841 | 12537184 | 11 | Product used for unknown indication |
125371841 | 12537184 | 12 | Product used for unknown indication |
125371841 | 12537184 | 13 | Product used for unknown indication |
125371841 | 12537184 | 14 | Product used for unknown indication |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125371841 | 12537184 | Malaise |
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 |
---|---|---|---|---|---|---|
125371841 | 12537184 | 1 | 201212 | 201212 | 0 | |
125371841 | 12537184 | 3 | 201412 | 2015 | 0 | |
125371841 | 12537184 | 4 | 20140717 | 0 | ||
125371841 | 12537184 | 5 | 20140717 | 0 | ||
125371841 | 12537184 | 6 | 20140717 | 0 | ||
125371841 | 12537184 | 7 | 20130717 | 20140717 | 0 |