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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127090671 | 12709067 | 1 | I | 2007 | 20160503 | 20160901 | 20160901 | PER | US-JAZZ-2016-US-008413 | JAZZ | 0.00 | F | Y | 55.78000 | KG | 20160901 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127090671 | 12709067 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
127090671 | 12709067 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
127090671 | 12709067 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, FIRST DOSE | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
127090671 | 12709067 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, SECOND DOSE | 21196 | 3 | G | ORAL SOLUTION | |||||||
127090671 | 12709067 | 5 | SS | MISOPROSTOL. | MISOPROSTOL | 1 | U | 0 | |||||||||||
127090671 | 12709067 | 6 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK, QD | U | 0 | ||||||||||
127090671 | 12709067 | 7 | C | ASPERCREME NOS | MENTHOLTROLAMINE SALICYLATE | 1 | UNK | U | 0 | CREAM |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
127090671 | 12709067 | 1 | Narcolepsy |
127090671 | 12709067 | 2 | Cataplexy |
127090671 | 12709067 | 5 | Product used for unknown indication |
127090671 | 12709067 | 6 | Periodic limb movement disorder |
127090671 | 12709067 | 7 | Product used for unknown indication |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
127090671 | 12709067 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
127090671 | 12709067 | Essential tremor | |
127090671 | 12709067 | Headache | |
127090671 | 12709067 | Muscle spasms | |
127090671 | 12709067 | Nausea | |
127090671 | 12709067 | Pruritus | |
127090671 | 12709067 | Rash | |
127090671 | 12709067 | Tremor | |
127090671 | 12709067 | Weight decreased | |
127090671 | 12709067 | Weight increased |
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 |
---|---|---|---|---|---|---|
127090671 | 12709067 | 1 | 200609 | 2006 | 0 | |
127090671 | 12709067 | 6 | 20141001 | 0 | ||
127090671 | 12709067 | 7 | 201504 | 0 |