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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124212912 | 12421291 | 2 | F | 2015 | 20160909 | 20160531 | 20160916 | PER | US-JAZZ-2015-US-016818 | JAZZ | 20.51 | YR | M | Y | 0.00000 | 20160916 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124212912 | 12421291 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 124212912 | 12421291 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 124212912 | 12421291 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 124212912 | 12421291 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.25 G, BID | U | 21196 | 3.25 | G | ORAL SOLUTION | ||||||
| 124212912 | 12421291 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 124212912 | 12421291 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 124212912 | 12421291 | 7 | C | ABILIFY | ARIPIPRAZOLE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124212912 | 12421291 | 8 | C | ABILIFY | ARIPIPRAZOLE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124212912 | 12421291 | 9 | C | FOCALIN | DEXMETHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124212912 | 12421291 | 10 | C | FOCALIN | DEXMETHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124212912 | 12421291 | 11 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 124212912 | 12421291 | 12 | C | MEGACE | MEGESTROL ACETATE | 1 | UNK | U | 0 | SUSPENSION | |||||||||
| 124212912 | 12421291 | 13 | C | L-methylfolate | 2 | UNK | U | 0 | |||||||||||
| 124212912 | 12421291 | 14 | C | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 124212912 | 12421291 | 15 | C | ONDANSETRON HYDROCHLORIDE. | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124212912 | 12421291 | 1 | Narcolepsy |
| 124212912 | 12421291 | 7 | Product used for unknown indication |
| 124212912 | 12421291 | 9 | Product used for unknown indication |
| 124212912 | 12421291 | 10 | Product used for unknown indication |
| 124212912 | 12421291 | 11 | Product used for unknown indication |
| 124212912 | 12421291 | 12 | Product used for unknown indication |
| 124212912 | 12421291 | 13 | Product used for unknown indication |
| 124212912 | 12421291 | 14 | Product used for unknown indication |
| 124212912 | 12421291 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124212912 | 12421291 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124212912 | 12421291 | Abdominal discomfort | |
| 124212912 | 12421291 | Condition aggravated | |
| 124212912 | 12421291 | Depression | |
| 124212912 | 12421291 | Diarrhoea | |
| 124212912 | 12421291 | Muscle spasms | |
| 124212912 | 12421291 | Nausea | |
| 124212912 | 12421291 | Neuralgia | |
| 124212912 | 12421291 | Paraesthesia |
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 |
|---|---|---|---|---|---|---|
| 124212912 | 12421291 | 1 | 201510 | 2015 | 0 | |
| 124212912 | 12421291 | 2 | 2015 | 2015 | 0 | |
| 124212912 | 12421291 | 3 | 2015 | 2015 | 0 | |
| 124212912 | 12421291 | 4 | 2015 | 2015 | 0 | |
| 124212912 | 12421291 | 5 | 2015 | 2015 | 0 | |
| 124212912 | 12421291 | 7 | 20150918 | 20150921 | 0 | |
| 124212912 | 12421291 | 8 | 20150922 | 20151001 | 0 | |
| 124212912 | 12421291 | 9 | 20150921 | 20150921 | 0 | |
| 124212912 | 12421291 | 10 | 20150921 | 20150921 | 0 | |
| 124212912 | 12421291 | 11 | 20150918 | 0 | ||
| 124212912 | 12421291 | 12 | 20160113 | 0 | ||
| 124212912 | 12421291 | 14 | 20160113 | 0 | ||
| 124212912 | 12421291 | 15 | 20160113 | 0 |