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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114729942 | 11472994 | 2 | F | 2013 | 20160921 | 20150908 | 20160929 | PER | US-JAZZ-2013-US-000065 | JAZZ | 0.00 | M | Y | 0.00000 | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114729942 | 11472994 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 114729942 | 11472994 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 BID | Y | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 114729942 | 11472994 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.25 G, FIRST DOSE | Y | 21196 | 3.25 | G | ORAL SOLUTION | ||||||
| 114729942 | 11472994 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.0 G, SECOND DOSE | Y | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 114729942 | 11472994 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.25 G, BID | Y | 21196 | 3.25 | G | ORAL SOLUTION | ||||||
| 114729942 | 11472994 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.25 G, FIRST DOSE | Y | 21196 | 3.25 | G | ORAL SOLUTION | ||||||
| 114729942 | 11472994 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.0 G, SECOND DOSE | Y | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 114729942 | 11472994 | 8 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, FIRST DOSE | Y | 21196 | 3.5 | G | ORAL SOLUTION | ||||||
| 114729942 | 11472994 | 9 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.0 G, SECOND DOSE | Y | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 114729942 | 11472994 | 10 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 114729942 | 11472994 | 11 | C | BACLOFEN. | BACLOFEN | 1 | UNK | 0 | TABLET | ||||||||||
| 114729942 | 11472994 | 12 | C | Fish oil concentrate | 2 | UNK | 0 | ||||||||||||
| 114729942 | 11472994 | 13 | C | LYRICA | PREGABALIN | 1 | UNK | 0 | CAPSULE | ||||||||||
| 114729942 | 11472994 | 14 | C | Multivitamin | VITAMINS | 1 | UNK | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114729942 | 11472994 | 1 | Cataplexy |
| 114729942 | 11472994 | 2 | Narcolepsy |
| 114729942 | 11472994 | 10 | Product used for unknown indication |
| 114729942 | 11472994 | 11 | Product used for unknown indication |
| 114729942 | 11472994 | 12 | Product used for unknown indication |
| 114729942 | 11472994 | 13 | Product used for unknown indication |
| 114729942 | 11472994 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114729942 | 11472994 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114729942 | 11472994 | Abdominal pain upper | |
| 114729942 | 11472994 | Blood cortisol increased | |
| 114729942 | 11472994 | Drug interaction | |
| 114729942 | 11472994 | Feeling abnormal | |
| 114729942 | 11472994 | Gastritis | |
| 114729942 | 11472994 | Hypersensitivity | |
| 114729942 | 11472994 | Loss of consciousness | |
| 114729942 | 11472994 | Thirst | |
| 114729942 | 11472994 | Trance |
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 |
|---|---|---|---|---|---|---|
| 114729942 | 11472994 | 1 | 201201 | 2012 | 0 | |
| 114729942 | 11472994 | 2 | 201204 | 2012 | 0 | |
| 114729942 | 11472994 | 3 | 201206 | 2012 | 0 | |
| 114729942 | 11472994 | 4 | 201206 | 2012 | 0 | |
| 114729942 | 11472994 | 5 | 2012 | 201303 | 0 | |
| 114729942 | 11472994 | 6 | 201303 | 0 | ||
| 114729942 | 11472994 | 7 | 201303 | 0 | ||
| 114729942 | 11472994 | 10 | 20130130 | 0 |