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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127144651 | 12714465 | 1 | I | 201605 | 20160512 | 20160905 | 20160905 | PER | US-JAZZ-2016-US-009002 | JAZZ | 32.45 | YR | F | Y | 108.84000 | KG | 20160905 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127144651 | 12714465 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 18 | G | N | 21196 | 2.25 | G | ORAL SOLUTION | ||||
127144651 | 12714465 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 18 | G | N | 21196 | 3 | G | ORAL SOLUTION | ||||
127144651 | 12714465 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | UNKNOWN DOSE | 18 | G | N | 21196 | ORAL SOLUTION | ||||||
127144651 | 12714465 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 18 | G | N | 21196 | 3 | G | ORAL SOLUTION | ||||
127144651 | 12714465 | 5 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | N | 0 | |||||||||||
127144651 | 12714465 | 6 | C | AMOXICILLIN. | AMOXICILLIN | 1 | U | 0 | |||||||||||
127144651 | 12714465 | 7 | C | EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
127144651 | 12714465 | 8 | C | NUVIGIL | ARMODAFINIL | 1 | U | 0 | |||||||||||
127144651 | 12714465 | 9 | C | XANAX | ALPRAZOLAM | 1 | U | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
127144651 | 12714465 | 1 | Narcolepsy |
127144651 | 12714465 | 2 | Cataplexy |
127144651 | 12714465 | 5 | Product used for unknown indication |
127144651 | 12714465 | 7 | Anxiety |
127144651 | 12714465 | 8 | Narcolepsy |
127144651 | 12714465 | 9 | Anxiety |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
127144651 | 12714465 | Fatigue | |
127144651 | 12714465 | Feeling abnormal | |
127144651 | 12714465 | Headache | |
127144651 | 12714465 | Hypertension | |
127144651 | 12714465 | Lethargy | |
127144651 | 12714465 | Pain in extremity | |
127144651 | 12714465 | 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 |
---|---|---|---|---|---|---|
127144651 | 12714465 | 1 | 201603 | 20160510 | 0 | |
127144651 | 12714465 | 2 | 20160510 | 20160512 | 0 | |
127144651 | 12714465 | 3 | 201605 | 20160522 | 0 | |
127144651 | 12714465 | 4 | 20160522 | 0 |