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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125239611 | 12523961 | 1 | I | 20151224 | 20160704 | 20160704 | PER | US-JAZZ-2015-US-022491 | JAZZ | 0.00 | F | Y | 0.00000 | 20160704 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125239611 | 12523961 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.5 G, BID | 21196 | 1.5 | G | ORAL SOLUTION | |||||||
| 125239611 | 12523961 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125239611 | 12523961 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 125239611 | 12523961 | 4 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239611 | 12523961 | 5 | C | CLARITIN-D 12 HOUR | LORATADINEPSEUDOEPHEDRINE SULFATE | 1 | 24 HOUR TABLET | U | 0 | TABLET | |||||||||
| 125239611 | 12523961 | 6 | C | MUCINEX DM | DEXTROMETHORPHAN HYDROBROMIDEGUAIFENESIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239611 | 12523961 | 7 | C | SUDAFED | PSEUDOEPHEDRINE HYDROCHLORIDE | 1 | 12 HOUR CAPLET | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125239611 | 12523961 | 1 | Narcolepsy |
| 125239611 | 12523961 | 4 | Product used for unknown indication |
| 125239611 | 12523961 | 5 | Product used for unknown indication |
| 125239611 | 12523961 | 6 | Product used for unknown indication |
| 125239611 | 12523961 | 7 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125239611 | 12523961 | Malaise |
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 |
|---|---|---|---|---|---|---|
| 125239611 | 12523961 | 1 | 201405 | 201405 | 0 | |
| 125239611 | 12523961 | 3 | 201412 | 0 | ||
| 125239611 | 12523961 | 4 | 20140101 | 0 |