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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125529482 | 12552948 | 2 | F | 20141101 | 20160715 | 20160713 | 20160722 | EXP | US-JAZZ-2016-US-012537 | JAZZ | 33.00 | YR | F | Y | 0.00000 | 20160722 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125529482 | 12552948 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2 G, BID | U | 21196 | 2 | G | ORAL SOLUTION | ||||||
| 125529482 | 12552948 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 125529482 | 12552948 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 125529482 | 12552948 | 4 | SS | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | N | 0 | ||||||||||
| 125529482 | 12552948 | 5 | C | TRAMADOL HCL | TRAMADOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125529482 | 12552948 | 6 | C | NATURE-THROID | THYROID, PORCINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125529482 | 12552948 | 7 | C | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125529482 | 12552948 | 8 | C | Trihexyphenidyl | TRIHEXYPHENIDYL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125529482 | 12552948 | 9 | C | BOTOX | ONABOTULINUMTOXINA | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125529482 | 12552948 | 1 | Fibromyalgia |
| 125529482 | 12552948 | 4 | Product used for unknown indication |
| 125529482 | 12552948 | 5 | Product used for unknown indication |
| 125529482 | 12552948 | 6 | Product used for unknown indication |
| 125529482 | 12552948 | 7 | Product used for unknown indication |
| 125529482 | 12552948 | 8 | Product used for unknown indication |
| 125529482 | 12552948 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125529482 | 12552948 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125529482 | 12552948 | Appendicectomy | |
| 125529482 | 12552948 | Drug ineffective | |
| 125529482 | 12552948 | Gastrointestinal disorder | |
| 125529482 | 12552948 | Memory impairment | |
| 125529482 | 12552948 | Torticollis |
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 |
|---|---|---|---|---|---|---|
| 125529482 | 12552948 | 1 | 200807 | 200807 | 0 | |
| 125529482 | 12552948 | 2 | 200807 | 2008 | 0 | |
| 125529482 | 12552948 | 3 | 2008 | 0 | ||
| 125529482 | 12552948 | 4 | 200807 | 0 | ||
| 125529482 | 12552948 | 5 | 20160702 | 20160702 | 0 | |
| 125529482 | 12552948 | 6 | 201407 | 0 | ||
| 125529482 | 12552948 | 7 | 20130702 | 0 | ||
| 125529482 | 12552948 | 8 | 201107 | 0 | ||
| 125529482 | 12552948 | 9 | 200901 | 0 |