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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124974272 | 12497427 | 2 | F | 201506 | 20160630 | 20160624 | 20160708 | EXP | US-JAZZ-2016-US-011352 | JAZZ | 53.43 | YR | F | Y | 0.00000 | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124974272 | 12497427 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 124974272 | 12497427 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 124974272 | 12497427 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 124974272 | 12497427 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 124974272 | 12497427 | 5 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124974272 | 12497427 | 6 | C | CYANOCOBALAMIN. | CYANOCOBALAMIN | 1 | UNK | U | 0 | ||||||||||
| 124974272 | 12497427 | 7 | C | HUMIRA | ADALIMUMAB | 1 | UNK | U | 0 | ||||||||||
| 124974272 | 12497427 | 8 | C | Amphetamine salts | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124974272 | 12497427 | 9 | C | Metformin hcl | METFORMIN HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124974272 | 12497427 | 10 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124974272 | 12497427 | 11 | C | FOLIC ACID. | FOLIC ACID | 1 | UNK | U | 0 | TABLET | |||||||||
| 124974272 | 12497427 | 12 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 124974272 | 12497427 | 13 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | ||||||||||
| 124974272 | 12497427 | 14 | C | MELOXICAM. | MELOXICAM | 1 | U | 0 | TABLET | ||||||||||
| 124974272 | 12497427 | 15 | C | ULORIC | FEBUXOSTAT | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124974272 | 12497427 | 1 | Hypersomnia |
| 124974272 | 12497427 | 5 | Product used for unknown indication |
| 124974272 | 12497427 | 6 | Product used for unknown indication |
| 124974272 | 12497427 | 7 | Product used for unknown indication |
| 124974272 | 12497427 | 8 | Product used for unknown indication |
| 124974272 | 12497427 | 9 | Product used for unknown indication |
| 124974272 | 12497427 | 10 | Product used for unknown indication |
| 124974272 | 12497427 | 11 | Product used for unknown indication |
| 124974272 | 12497427 | 12 | Product used for unknown indication |
| 124974272 | 12497427 | 13 | Product used for unknown indication |
| 124974272 | 12497427 | 14 | Product used for unknown indication |
| 124974272 | 12497427 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124974272 | 12497427 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124974272 | 12497427 | Arthralgia | |
| 124974272 | 12497427 | Diarrhoea | |
| 124974272 | 12497427 | Inflammation | |
| 124974272 | 12497427 | Malaise | |
| 124974272 | 12497427 | Rotator cuff repair |
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 |
|---|---|---|---|---|---|---|
| 124974272 | 12497427 | 1 | 201302 | 201303 | 0 | |
| 124974272 | 12497427 | 2 | 201303 | 201303 | 0 | |
| 124974272 | 12497427 | 3 | 201303 | 2015 | 0 | |
| 124974272 | 12497427 | 4 | 201602 | 0 | ||
| 124974272 | 12497427 | 5 | 20140619 | 0 | ||
| 124974272 | 12497427 | 6 | 20140303 | 0 | ||
| 124974272 | 12497427 | 7 | 20130814 | 201602 | 0 | |
| 124974272 | 12497427 | 8 | 20120201 | 201602 | 0 | |
| 124974272 | 12497427 | 9 | 20120201 | 201602 | 0 | |
| 124974272 | 12497427 | 10 | 20110201 | 201602 | 0 | |
| 124974272 | 12497427 | 11 | 20110201 | 201602 | 0 | |
| 124974272 | 12497427 | 12 | 20110201 | 201602 | 0 | |
| 124974272 | 12497427 | 13 | 20110201 | 0 |