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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127472751 | 12747275 | 1 | I | 2016 | 20160525 | 20160915 | 20160915 | PER | US-JAZZ-2016-US-009809 | JAZZ | 32.25 | YR | F | Y | 0.00000 | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127472751 | 12747275 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 4 | G | N | 21196 | 2.25 | G | ORAL SOLUTION | ||||
| 127472751 | 12747275 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | UNK, QD | 4 | G | N | 21196 | ORAL SOLUTION | ||||||
| 127472751 | 12747275 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.5 G, BID | 4 | G | N | 21196 | 1.5 | G | ORAL SOLUTION | ||||
| 127472751 | 12747275 | 4 | SS | NUVIGIL | ARMODAFINIL | 1 | N | 0 | |||||||||||
| 127472751 | 12747275 | 5 | C | COENZYME Q10 | UBIDECARENONE | 1 | U | 0 | |||||||||||
| 127472751 | 12747275 | 6 | C | L Tyrosine | 2 | U | 0 | ||||||||||||
| 127472751 | 12747275 | 7 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | U | 0 | |||||||||||
| 127472751 | 12747275 | 8 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127472751 | 12747275 | 1 | Narcolepsy |
| 127472751 | 12747275 | 2 | Cataplexy |
| 127472751 | 12747275 | 4 | Narcolepsy |
| 127472751 | 12747275 | 5 | Supplementation therapy |
| 127472751 | 12747275 | 6 | Supplementation therapy |
| 127472751 | 12747275 | 7 | Supplementation therapy |
| 127472751 | 12747275 | 8 | Narcolepsy |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127472751 | 12747275 | Disorientation | |
| 127472751 | 12747275 | Drug ineffective | |
| 127472751 | 12747275 | Feeling abnormal | |
| 127472751 | 12747275 | Feeling drunk | |
| 127472751 | 12747275 | Heart rate increased | |
| 127472751 | 12747275 | Malaise | |
| 127472751 | 12747275 | Nausea | |
| 127472751 | 12747275 | Pain | |
| 127472751 | 12747275 | Poor quality sleep | |
| 127472751 | 12747275 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 127472751 | 12747275 | 1 | 20160523 | 20160523 | 0 | |
| 127472751 | 12747275 | 2 | 20160524 | 20160524 | 0 | |
| 127472751 | 12747275 | 3 | 2016 | 0 |