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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118682207 | 11868220 | 7 | F | 20101211 | 20160711 | 20151224 | 20160719 | EXP | US-JAZZ-JPI-P-014259 | JAZZ | 49.23 | YR | F | Y | 0.00000 | 20160719 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118682207 | 11868220 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 118682207 | 11868220 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | Y | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 118682207 | 11868220 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | Y | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 118682207 | 11868220 | 4 | SS | Oxycodone | OXYCODONE | 1 | Y | 0 | |||||||||||
| 118682207 | 11868220 | 5 | SS | ROBAXIN | METHOCARBAMOL | 1 | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118682207 | 11868220 | 1 | Narcolepsy |
| 118682207 | 11868220 | 4 | Product used for unknown indication |
| 118682207 | 11868220 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118682207 | 11868220 | OT |
| 118682207 | 11868220 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118682207 | 11868220 | Hallucination | |
| 118682207 | 11868220 | Intervertebral disc protrusion | |
| 118682207 | 11868220 | Ligament sprain | |
| 118682207 | 11868220 | Middle ear effusion | |
| 118682207 | 11868220 | Migraine | |
| 118682207 | 11868220 | Neck surgery | |
| 118682207 | 11868220 | Post procedural complication | |
| 118682207 | 11868220 | Post-traumatic neck syndrome | |
| 118682207 | 11868220 | Road traffic accident | |
| 118682207 | 11868220 | Scoliosis | |
| 118682207 | 11868220 | Tooth fracture | |
| 118682207 | 11868220 | Vomiting projectile | |
| 118682207 | 11868220 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 118682207 | 11868220 | 1 | 20091106 | 20091126 | 0 | |
| 118682207 | 11868220 | 2 | 20091127 | 20110218 | 0 | |
| 118682207 | 11868220 | 3 | 20110222 | 0 |