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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117795342 | 11779534 | 2 | F | 201208 | 20160627 | 20151125 | 20160701 | EXP | US-JAZZ-JPI-P-031958 | JAZZ | 62.56 | YR | F | Y | 70.46000 | KG | 20160701 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117795342 | 11779534 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | 21196 | 4 | G | ORAL SOLUTION | |||||||
| 117795342 | 11779534 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 117795342 | 11779534 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | 21196 | 4 | G | ORAL SOLUTION | |||||||
| 117795342 | 11779534 | 4 | SS | CRESTOR | ROSUVASTATIN CALCIUM | 1 | U | 0 | |||||||||||
| 117795342 | 11779534 | 5 | C | Acetylsalicylic acid | ASPIRIN | 1 | U | 0 | 81 | MG | |||||||||
| 117795342 | 11779534 | 6 | C | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | 70 MG SINGLE (STARTED IN 2000 OR 2001) | U | 0 | 70 | MG | ||||||||
| 117795342 | 11779534 | 7 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | 60 MG, QD | U | 0 | 60 | MG | ||||||||
| 117795342 | 11779534 | 8 | C | XANAX | ALPRAZOLAM | 1 | Oral | 1 MG, TID | U | 0 | 1 | MG | |||||||
| 117795342 | 11779534 | 9 | C | Hydroxychloroquine | HYDROXYCHLOROQUINE | 1 | 200 MG, QD | U | 0 | 200 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117795342 | 11779534 | 1 | Fibromyalgia |
| 117795342 | 11779534 | 4 | Product used for unknown indication |
| 117795342 | 11779534 | 5 | Cardiovascular event prophylaxis |
| 117795342 | 11779534 | 6 | Osteoporosis prophylaxis |
| 117795342 | 11779534 | 7 | Product used for unknown indication |
| 117795342 | 11779534 | 8 | Product used for unknown indication |
| 117795342 | 11779534 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117795342 | 11779534 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117795342 | 11779534 | Autoimmune disorder | |
| 117795342 | 11779534 | Blood cholesterol increased | |
| 117795342 | 11779534 | Burning sensation | |
| 117795342 | 11779534 | Dental caries | |
| 117795342 | 11779534 | Food allergy | |
| 117795342 | 11779534 | Histamine intolerance | |
| 117795342 | 11779534 | Immunodeficiency common variable | |
| 117795342 | 11779534 | Myalgia | |
| 117795342 | 11779534 | Neuropathy peripheral | |
| 117795342 | 11779534 | Onychomycosis | |
| 117795342 | 11779534 | Rheumatoid arthritis | |
| 117795342 | 11779534 | Saliva altered | |
| 117795342 | 11779534 | Sjogren's syndrome | |
| 117795342 | 11779534 | Vasculitis |
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 |
|---|---|---|---|---|---|---|
| 117795342 | 11779534 | 1 | 200608 | 0 | ||
| 117795342 | 11779534 | 2 | 200701 | 2011 | 0 | |
| 117795342 | 11779534 | 3 | 201102 | 0 |