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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114862852 | 11486285 | 2 | F | 20160919 | 20150909 | 20160926 | PER | US-JAZZ-2015-US-003472 | JAZZ | 0.00 | F | Y | 72.11000 | KG | 20160926 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114862852 | 11486285 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 114862852 | 11486285 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 114862852 | 11486285 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 114862852 | 11486285 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 114862852 | 11486285 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | 21196 | 4 | G | ORAL SOLUTION | |||||||
| 114862852 | 11486285 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 114862852 | 11486285 | 7 | SS | METHYLPHENIDATE. | METHYLPHENIDATE | 1 | UNK | U | 0 | ||||||||||
| 114862852 | 11486285 | 8 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | 20 MG, UNK | U | 0 | 20 | MG | ||||||||
| 114862852 | 11486285 | 9 | C | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | 150 MG, UNK | U | 0 | 150 | MG | ||||||||
| 114862852 | 11486285 | 10 | C | NUVIGIL | ARMODAFINIL | 1 | 150 MG, UNK | U | 0 | 150 | MG | ||||||||
| 114862852 | 11486285 | 11 | C | KLONOPIN | CLONAZEPAM | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114862852 | 11486285 | 1 | Narcolepsy |
| 114862852 | 11486285 | 2 | Cataplexy |
| 114862852 | 11486285 | 7 | Product used for unknown indication |
| 114862852 | 11486285 | 8 | Product used for unknown indication |
| 114862852 | 11486285 | 9 | Product used for unknown indication |
| 114862852 | 11486285 | 10 | Product used for unknown indication |
| 114862852 | 11486285 | 11 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114862852 | 11486285 | Bruxism | |
| 114862852 | 11486285 | Depression | |
| 114862852 | 11486285 | Pre-existing condition improved |
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 |
|---|---|---|---|---|---|---|
| 114862852 | 11486285 | 1 | 200908 | 200908 | 0 | |
| 114862852 | 11486285 | 2 | 2009 | 2009 | 0 | |
| 114862852 | 11486285 | 3 | 200909 | 2009 | 0 | |
| 114862852 | 11486285 | 4 | 201310 | 201311 | 0 | |
| 114862852 | 11486285 | 5 | 201311 | 201312 | 0 | |
| 114862852 | 11486285 | 6 | 201312 | 0 | ||
| 114862852 | 11486285 | 8 | 20151224 | 0 | ||
| 114862852 | 11486285 | 9 | 20141224 | 0 | ||
| 114862852 | 11486285 | 10 | 20010101 | 0 | ||
| 114862852 | 11486285 | 11 | 20131101 | 0 |