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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109547738 | 10954773 | 8 | F | 201312 | 20160902 | 20150325 | 20160909 | EXP | CA-JAZZ-2015-CA-004292 | JAZZ | 78.27 | YR | M | Y | 0.00000 | 20160909 | CN | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109547738 | 10954773 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | UNKNOWN DOSE, BID | 21196 | ORAL SOLUTION | |||||||||
| 109547738 | 10954773 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 109547738 | 10954773 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 109547738 | 10954773 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, QD | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 109547738 | 10954773 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 109547738 | 10954773 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 109547738 | 10954773 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, BID | 21196 | 3.5 | G | ORAL SOLUTION | |||||||
| 109547738 | 10954773 | 8 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 109547738 | 10954773 | 9 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 6 G PER NIGHT | 21196 | ORAL SOLUTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109547738 | 10954773 | 1 | Narcolepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109547738 | 10954773 | HO |
| 109547738 | 10954773 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109547738 | 10954773 | Cardiac disorder | |
| 109547738 | 10954773 | Cardiac pacemaker insertion | |
| 109547738 | 10954773 | Cataplexy | |
| 109547738 | 10954773 | Confusional state | |
| 109547738 | 10954773 | Drug dose omission | |
| 109547738 | 10954773 | Drug ineffective | |
| 109547738 | 10954773 | Fall | |
| 109547738 | 10954773 | Injury | |
| 109547738 | 10954773 | Insomnia | |
| 109547738 | 10954773 | Medication error | |
| 109547738 | 10954773 | Sleep disorder | |
| 109547738 | 10954773 | Somnambulism |
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 |
|---|---|---|---|---|---|---|
| 109547738 | 10954773 | 1 | 20080508 | 0 | ||
| 109547738 | 10954773 | 2 | 20080527 | 0 | ||
| 109547738 | 10954773 | 3 | 20081015 | 0 | ||
| 109547738 | 10954773 | 4 | 20141028 | 0 | ||
| 109547738 | 10954773 | 5 | 20150310 | 0 | ||
| 109547738 | 10954773 | 6 | 20150329 | 0 | ||
| 109547738 | 10954773 | 7 | 201508 | 2015 | 0 | |
| 109547738 | 10954773 | 8 | 20151006 | 0 |