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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123394012 | 12339401 | 2 | F | 201507 | 20160908 | 20160505 | 20160913 | PER | US-JAZZ-2015-US-012840 | JAZZ | 23.82 | YR | F | Y | 65.76000 | KG | 20160913 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123394012 | 12339401 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | Y | 21196 | 2.25 | G | ORAL SOLUTION | |||||
| 123394012 | 12339401 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | Y | 21196 | ORAL SOLUTION | |||||||
| 123394012 | 12339401 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.25 G, BID | Y | Y | 21196 | 3.25 | G | ORAL SOLUTION | |||||
| 123394012 | 12339401 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | Y | Y | 21196 | 4 | G | ORAL SOLUTION | |||||
| 123394012 | 12339401 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.25 G, BID | Y | Y | 21196 | 3.25 | G | ORAL SOLUTION | |||||
| 123394012 | 12339401 | 6 | C | TRI-PREVIFEM | ETHINYL ESTRADIOLNORGESTIMATE | 1 | UNK | 0 | |||||||||||
| 123394012 | 12339401 | 7 | C | TRI-PREVIFEM | ETHINYL ESTRADIOLNORGESTIMATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123394012 | 12339401 | 1 | Narcolepsy |
| 123394012 | 12339401 | 6 | Dysmenorrhoea |
| 123394012 | 12339401 | 7 | Contraception |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123394012 | 12339401 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123394012 | 12339401 | Asthenia | |
| 123394012 | 12339401 | Decreased appetite | |
| 123394012 | 12339401 | Defaecation urgency | |
| 123394012 | 12339401 | Diarrhoea | |
| 123394012 | 12339401 | Gastritis | |
| 123394012 | 12339401 | Nausea | |
| 123394012 | 12339401 | Pre-existing condition improved | |
| 123394012 | 12339401 | Therapeutic response unexpected | |
| 123394012 | 12339401 | 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 |
|---|---|---|---|---|---|---|
| 123394012 | 12339401 | 1 | 201507 | 2015 | 0 | |
| 123394012 | 12339401 | 2 | 2015 | 2015 | 0 | |
| 123394012 | 12339401 | 3 | 201508 | 2015 | 0 | |
| 123394012 | 12339401 | 4 | 2015 | 0 | ||
| 123394012 | 12339401 | 6 | 20140601 | 0 |