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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127478121 | 12747812 | 1 | I | 20160527 | 20160915 | 20160915 | PER | US-JAZZ-2016-US-010050 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127478121 | 12747812 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 127478121 | 12747812 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 127478121 | 12747812 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 127478121 | 12747812 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 127478121 | 12747812 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 127478121 | 12747812 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 127478121 | 12747812 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 127478121 | 12747812 | 8 | SS | NUVIGIL | ARMODAFINIL | 1 | U | 0 | |||||||||||
| 127478121 | 12747812 | 9 | C | EPIPEN | EPINEPHRINE | 1 | U | 0 | |||||||||||
| 127478121 | 12747812 | 10 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | U | 0 | |||||||||||
| 127478121 | 12747812 | 11 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | U | 0 | |||||||||||
| 127478121 | 12747812 | 12 | C | Belladonna and phenobarbitone | 2 | U | 0 | ||||||||||||
| 127478121 | 12747812 | 13 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | U | 0 | |||||||||||
| 127478121 | 12747812 | 14 | C | PROVIGIL | MODAFINIL | 1 | 100 MG, UNK | U | 0 | 100 | MG | ||||||||
| 127478121 | 12747812 | 15 | C | PROVIGIL | MODAFINIL | 1 | 200 MG, UNK | U | 0 | 200 | MG | ||||||||
| 127478121 | 12747812 | 16 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | 5 MG, UNK | U | 0 | 5 | MG | ||||||||
| 127478121 | 12747812 | 17 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | 20 MG, UNK | U | 0 | 20 | MG | ||||||||
| 127478121 | 12747812 | 18 | C | VENTOLIN HFA | ALBUTEROL SULFATE | 1 | U | 0 | |||||||||||
| 127478121 | 12747812 | 19 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | |||||||||||
| 127478121 | 12747812 | 20 | C | BREO ELLIPTA | FLUTICASONE FUROATEVILANTEROL TRIFENATATE | 1 | U | 0 | |||||||||||
| 127478121 | 12747812 | 21 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127478121 | 12747812 | 1 | Narcolepsy |
| 127478121 | 12747812 | 8 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127478121 | 12747812 | Drug hypersensitivity |
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 |
|---|---|---|---|---|---|---|
| 127478121 | 12747812 | 1 | 201008 | 201008 | 0 | |
| 127478121 | 12747812 | 2 | 201008 | 201008 | 0 | |
| 127478121 | 12747812 | 3 | 201008 | 2011 | 0 | |
| 127478121 | 12747812 | 4 | 201307 | 201307 | 0 | |
| 127478121 | 12747812 | 5 | 201307 | 201307 | 0 | |
| 127478121 | 12747812 | 6 | 201307 | 0 | ||
| 127478121 | 12747812 | 7 | 201406 | 0 |