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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123532142 | 12353214 | 2 | F | 200901 | 20160712 | 20160510 | 20160720 | EXP | US-JAZZ-JPI-P-006537 | JAZZ | 36.27 | YR | F | Y | 76.00000 | KG | 20160720 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123532142 | 12353214 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 123532142 | 12353214 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 123532142 | 12353214 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | 21196 | ORAL SOLUTION | |||||||||||
| 123532142 | 12353214 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | 21196 | ORAL SOLUTION | |||||||||||
| 123532142 | 12353214 | 5 | SS | NUVIGIL | ARMODAFINIL | 1 | U | 0 | |||||||||||
| 123532142 | 12353214 | 6 | SS | CELEBREX | CELECOXIB | 1 | U | 0 | 100 | MG | |||||||||
| 123532142 | 12353214 | 7 | SS | ORACEA | DOXYCYCLINE | 1 | U | 0 | |||||||||||
| 123532142 | 12353214 | 8 | C | ZOLPIDEM | ZOLPIDEMOLPIDEM TARTRATE | 1 | U | 0 | 10 | MG | |||||||||
| 123532142 | 12353214 | 9 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | U | 0 | |||||||||||
| 123532142 | 12353214 | 10 | C | Naltrexone | NALTREXONE | 1 | U | 0 | 50 | MG | |||||||||
| 123532142 | 12353214 | 11 | C | TIZANIDINE. | TIZANIDINE | 1 | U | 0 | 4 | MG | |||||||||
| 123532142 | 12353214 | 12 | C | TIZANIDINE. | TIZANIDINE | 1 | U | 0 | |||||||||||
| 123532142 | 12353214 | 13 | C | TIZANIDINE. | TIZANIDINE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123532142 | 12353214 | 1 | Narcolepsy |
| 123532142 | 12353214 | 2 | Cataplexy |
| 123532142 | 12353214 | 3 | Insomnia |
| 123532142 | 12353214 | 4 | Fibromyalgia |
| 123532142 | 12353214 | 5 | Product used for unknown indication |
| 123532142 | 12353214 | 6 | Arthritis |
| 123532142 | 12353214 | 7 | Product used for unknown indication |
| 123532142 | 12353214 | 8 | Insomnia |
| 123532142 | 12353214 | 9 | Neuropathy peripheral |
| 123532142 | 12353214 | 10 | Pain |
| 123532142 | 12353214 | 11 | Pain |
| 123532142 | 12353214 | 12 | Fibromyalgia |
| 123532142 | 12353214 | 13 | Arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123532142 | 12353214 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123532142 | 12353214 | Arthralgia | |
| 123532142 | 12353214 | Blood pressure abnormal | |
| 123532142 | 12353214 | Cholecystectomy | |
| 123532142 | 12353214 | Decreased appetite | |
| 123532142 | 12353214 | Dyspepsia | |
| 123532142 | 12353214 | Gastritis | |
| 123532142 | 12353214 | Heart rate increased | |
| 123532142 | 12353214 | Impaired gastric emptying | |
| 123532142 | 12353214 | Photosensitivity reaction | |
| 123532142 | 12353214 | Vitamin D decreased | |
| 123532142 | 12353214 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 123532142 | 12353214 | 1 | 20080820 | 20081005 | 0 | |
| 123532142 | 12353214 | 2 | 20081006 | 0 |