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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126508761 | 12650876 | 1 | I | 20130916 | 20131022 | 20160815 | 20160815 | PER | US-JAZZ-2013-US-002496 | JAZZ | 16.77 | YR | M | Y | 107.94000 | KG | 20160815 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126508761 | 12650876 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 3097762 | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126508761 | 12650876 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.5 G, BID | 21196 | 2.5 | G | ORAL SOLUTION | |||||||
| 126508761 | 12650876 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.75 G, BID | 21196 | 2.75 | G | ORAL SOLUTION | |||||||
| 126508761 | 12650876 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 126508761 | 12650876 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, BID | 3109214 | 21196 | 3.5 | G | ORAL SOLUTION | ||||||
| 126508761 | 12650876 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | 3110636 | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 126508761 | 12650876 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | 3109219 | 21196 | 4 | G | ORAL SOLUTION | ||||||
| 126508761 | 12650876 | 8 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 126508761 | 12650876 | 9 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | 30 MG, QD | Y | 0 | 30 | MG | |||||||
| 126508761 | 12650876 | 10 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | 60 MG, QD | Y | 0 | 60 | MG | |||||||
| 126508761 | 12650876 | 11 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | 150 MG, | U | 0 | 150 | MG | ||||||||
| 126508761 | 12650876 | 12 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126508761 | 12650876 | 13 | C | ABILIFY | ARIPIPRAZOLE | 1 | Oral | 30 MG, QD | U | 0 | 30 | MG | |||||||
| 126508761 | 12650876 | 14 | C | MODAFINIL. | MODAFINIL | 1 | U | 0 | |||||||||||
| 126508761 | 12650876 | 15 | C | RISPERDAL | RISPERIDONE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126508761 | 12650876 | 1 | Narcolepsy |
| 126508761 | 12650876 | 2 | Cataplexy |
| 126508761 | 12650876 | 9 | Narcolepsy |
| 126508761 | 12650876 | 11 | Rapid eye movements sleep abnormal |
| 126508761 | 12650876 | 12 | Anxiety |
| 126508761 | 12650876 | 13 | Affective disorder |
| 126508761 | 12650876 | 14 | Product used for unknown indication |
| 126508761 | 12650876 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126508761 | 12650876 | OT |
| 126508761 | 12650876 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126508761 | 12650876 | Agitation | |
| 126508761 | 12650876 | Condition aggravated | |
| 126508761 | 12650876 | Delusion | |
| 126508761 | 12650876 | Hallucination, auditory | |
| 126508761 | 12650876 | Hallucination, visual | |
| 126508761 | 12650876 | Hypnagogic hallucination | |
| 126508761 | 12650876 | Insomnia | |
| 126508761 | 12650876 | Mood altered | |
| 126508761 | 12650876 | Nightmare | |
| 126508761 | 12650876 | Psychotic disorder | |
| 126508761 | 12650876 | Sleep disorder | |
| 126508761 | 12650876 | Suicide attempt | |
| 126508761 | 12650876 | Thinking abnormal |
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 |
|---|---|---|---|---|---|---|
| 126508761 | 12650876 | 1 | 201207 | 2012 | 0 | |
| 126508761 | 12650876 | 2 | 2012 | 2012 | 0 | |
| 126508761 | 12650876 | 3 | 2012 | 2012 | 0 | |
| 126508761 | 12650876 | 4 | 2012 | 0 | ||
| 126508761 | 12650876 | 5 | 201304 | 2013 | 0 | |
| 126508761 | 12650876 | 6 | 201307 | 2013 | 0 | |
| 126508761 | 12650876 | 7 | 2013 | 0 | ||
| 126508761 | 12650876 | 9 | 20130924 | 20130926 | 0 | |
| 126508761 | 12650876 | 10 | 20130927 | 20130928 | 0 |