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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116507773 | 11650777 | 3 | F | 20151013 | 20160921 | 20151021 | 20160928 | EXP | US-JAZZ-2015-US-016050 | JAZZ | 25.30 | YR | M | Y | 0.00000 | 20160928 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116507773 | 11650777 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 116507773 | 11650777 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 116507773 | 11650777 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 6 G, FIRST DOSE | Y | 21196 | 6 | G | ORAL SOLUTION | ||||||
| 116507773 | 11650777 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, SECOND DOSE | Y | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 116507773 | 11650777 | 5 | C | DEXTROAMPHETAMINE. | DEXTROAMPHETAMINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 116507773 | 11650777 | 6 | C | RISPERDAL | RISPERIDONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 116507773 | 11650777 | 7 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 116507773 | 11650777 | 8 | C | KLONOPIN | CLONAZEPAM | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116507773 | 11650777 | 1 | Narcolepsy |
| 116507773 | 11650777 | 2 | Somnolence |
| 116507773 | 11650777 | 3 | Cataplexy |
| 116507773 | 11650777 | 5 | Product used for unknown indication |
| 116507773 | 11650777 | 6 | Product used for unknown indication |
| 116507773 | 11650777 | 7 | Product used for unknown indication |
| 116507773 | 11650777 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116507773 | 11650777 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116507773 | 11650777 | Feeling abnormal | |
| 116507773 | 11650777 | Insomnia | |
| 116507773 | 11650777 | Intentional overdose | |
| 116507773 | 11650777 | Intentional product use issue | |
| 116507773 | 11650777 | Rehabilitation therapy | |
| 116507773 | 11650777 | Seizure | |
| 116507773 | 11650777 | Unresponsive to stimuli |
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 |
|---|---|---|---|---|---|---|
| 116507773 | 11650777 | 1 | 201408 | 2014 | 0 | |
| 116507773 | 11650777 | 3 | 201505 | 2015 | 0 | |
| 116507773 | 11650777 | 4 | 201505 | 2015 | 0 | |
| 116507773 | 11650777 | 5 | 20150512 | 0 | ||
| 116507773 | 11650777 | 6 | 20150512 | 0 | ||
| 116507773 | 11650777 | 7 | 20131101 | 0 | ||
| 116507773 | 11650777 | 8 | 20120101 | 0 |