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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109142783 | 10914278 | 3 | F | 2016 | 20160901 | 20150313 | 20160908 | EXP | US-JAZZ-2015-US-003554 | JAZZ | 0.00 | F | Y | 90.70000 | KG | 20160908 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109142783 | 10914278 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 109142783 | 10914278 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 109142783 | 10914278 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | 3 G, BID | Y | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 109142783 | 10914278 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | Y | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 109142783 | 10914278 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | Y | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 109142783 | 10914278 | 6 | SS | LYRICA | PREGABALIN | 1 | UNK | Y | 0 | CAPSULE | |||||||||
| 109142783 | 10914278 | 7 | C | TRAMADOL HCL | TRAMADOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 109142783 | 10914278 | 8 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 109142783 | 10914278 | 9 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 109142783 | 10914278 | 10 | C | Hydrocodone/acetaminophen | ACETAMINOPHENHYDROCODONE | 1 | UNK | U | 0 | ||||||||||
| 109142783 | 10914278 | 11 | C | CELEBREX | CELECOXIB | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 109142783 | 10914278 | 12 | C | BETHANECHOL CHLORIDE. | BETHANECHOL CHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 109142783 | 10914278 | 13 | C | CYANOCOBALAMIN. | CYANOCOBALAMIN | 1 | U | 0 | |||||||||||
| 109142783 | 10914278 | 14 | C | FOLIC ACID. | FOLIC ACID | 1 | U | 0 | TABLET | ||||||||||
| 109142783 | 10914278 | 15 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109142783 | 10914278 | 1 | Fibromyalgia |
| 109142783 | 10914278 | 6 | Fibromyalgia |
| 109142783 | 10914278 | 7 | Product used for unknown indication |
| 109142783 | 10914278 | 8 | Product used for unknown indication |
| 109142783 | 10914278 | 9 | Product used for unknown indication |
| 109142783 | 10914278 | 10 | Product used for unknown indication |
| 109142783 | 10914278 | 11 | Product used for unknown indication |
| 109142783 | 10914278 | 12 | Product used for unknown indication |
| 109142783 | 10914278 | 13 | Product used for unknown indication |
| 109142783 | 10914278 | 14 | Product used for unknown indication |
| 109142783 | 10914278 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109142783 | 10914278 | HO |
| 109142783 | 10914278 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109142783 | 10914278 | Drug ineffective | |
| 109142783 | 10914278 | Hip arthroplasty | |
| 109142783 | 10914278 | Intervertebral disc degeneration | |
| 109142783 | 10914278 | Pain |
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 |
|---|---|---|---|---|---|---|
| 109142783 | 10914278 | 1 | 200401 | 2004 | 0 | |
| 109142783 | 10914278 | 3 | 2004 | 2013 | 0 | |
| 109142783 | 10914278 | 4 | 201402 | 201409 | 0 | |
| 109142783 | 10914278 | 5 | 2014 | 0 | ||
| 109142783 | 10914278 | 6 | 20140213 | 0 | ||
| 109142783 | 10914278 | 7 | 20140213 | 0 | ||
| 109142783 | 10914278 | 8 | 20140213 | 0 | ||
| 109142783 | 10914278 | 9 | 20140213 | 0 | ||
| 109142783 | 10914278 | 10 | 20140213 | 0 | ||
| 109142783 | 10914278 | 11 | 20140213 | 0 | ||
| 109142783 | 10914278 | 12 | 20140213 | 0 |