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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127474991 | 12747499 | 1 | I | 20160524 | 20160915 | 20160915 | PER | US-JAZZ-2016-US-009685 | JAZZ | 0.00 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127474991 | 12747499 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127474991 | 12747499 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127474991 | 12747499 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127474991 | 12747499 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 127474991 | 12747499 | 5 | SS | NUVIGIL | ARMODAFINIL | 1 | U | 0 | |||||||||||
| 127474991 | 12747499 | 6 | SS | PROVIGIL | MODAFINIL | 1 | U | 0 | |||||||||||
| 127474991 | 12747499 | 7 | C | XANAX | ALPRAZOLAM | 1 | 0.25 MG, UNK | U | 0 | .25 | MG | ||||||||
| 127474991 | 12747499 | 8 | C | XANAX | ALPRAZOLAM | 1 | 0.5 MG, UNK | U | 0 | .5 | MG | ||||||||
| 127474991 | 12747499 | 9 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | |||||||||||
| 127474991 | 12747499 | 10 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | U | 0 | |||||||||||
| 127474991 | 12747499 | 11 | C | BUDESONIDE. | BUDESONIDE | 1 | U | 0 | |||||||||||
| 127474991 | 12747499 | 12 | C | CELEXA | CITALOPRAM HYDROBROMIDE | 1 | U | 0 | |||||||||||
| 127474991 | 12747499 | 13 | C | CLARITIN | LORATADINE | 1 | U | 0 | |||||||||||
| 127474991 | 12747499 | 14 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | U | 0 | |||||||||||
| 127474991 | 12747499 | 15 | C | MODAFINIL. | MODAFINIL | 1 | U | 0 | |||||||||||
| 127474991 | 12747499 | 16 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | U | 0 | |||||||||||
| 127474991 | 12747499 | 17 | C | VENTOLIN HFA | ALBUTEROL SULFATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127474991 | 12747499 | 1 | Narcolepsy |
| 127474991 | 12747499 | 2 | Cataplexy |
| 127474991 | 12747499 | 5 | Product used for unknown indication |
| 127474991 | 12747499 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127474991 | 12747499 | Contusion | |
| 127474991 | 12747499 | Cough | |
| 127474991 | 12747499 | Drug ineffective | |
| 127474991 | 12747499 | Drug tolerance | |
| 127474991 | 12747499 | Infection | |
| 127474991 | 12747499 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 127474991 | 12747499 | 1 | 200505 | 2005 | 0 | |
| 127474991 | 12747499 | 2 | 201506 | 201506 | 0 | |
| 127474991 | 12747499 | 4 | 201604 | 0 |