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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121735083 | 12173508 | 3 | F | 20160712 | 20160311 | 20160720 | EXP | US-JAZZ-2015-US-015980 | JAZZ | 0.00 | F | Y | 0.00000 | 20160720 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121735083 | 12173508 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 121735083 | 12173508 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 121735083 | 12173508 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 121735083 | 12173508 | 4 | SS | TRAMADOL. | TRAMADOL | 1 | UNK | N | 0 | TABLET | |||||||||
| 121735083 | 12173508 | 5 | C | PROVIGIL | MODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 121735083 | 12173508 | 6 | C | Klonopin 0.5 | 2 | UNK | U | 0 | TABLET | ||||||||||
| 121735083 | 12173508 | 7 | C | Klonopin 0.5 | 2 | UNK | U | 0 | TABLET | ||||||||||
| 121735083 | 12173508 | 8 | C | SKELAXIN | METAXALONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 121735083 | 12173508 | 9 | C | Hydroxyzine hcl | HYDROXYZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 121735083 | 12173508 | 10 | C | KLONOPIN | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 121735083 | 12173508 | 11 | C | TRAZODONE HYDROCHLORIDE. | TRAZODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 121735083 | 12173508 | 12 | C | MICROGESTIN | ETHINYL ESTRADIOLNORETHINDRONE ACETATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 121735083 | 12173508 | 13 | C | VIIBRYD | VILAZODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 121735083 | 12173508 | 14 | C | LAMICTAL | LAMOTRIGINE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121735083 | 12173508 | 1 | Narcolepsy |
| 121735083 | 12173508 | 4 | Product used for unknown indication |
| 121735083 | 12173508 | 5 | Product used for unknown indication |
| 121735083 | 12173508 | 6 | Product used for unknown indication |
| 121735083 | 12173508 | 8 | Product used for unknown indication |
| 121735083 | 12173508 | 9 | Product used for unknown indication |
| 121735083 | 12173508 | 10 | Product used for unknown indication |
| 121735083 | 12173508 | 11 | Product used for unknown indication |
| 121735083 | 12173508 | 12 | Product used for unknown indication |
| 121735083 | 12173508 | 13 | Product used for unknown indication |
| 121735083 | 12173508 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121735083 | 12173508 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121735083 | 12173508 | Condition aggravated | |
| 121735083 | 12173508 | Dyspnoea | |
| 121735083 | 12173508 | Endometriosis | |
| 121735083 | 12173508 | Malaise | |
| 121735083 | 12173508 | Nasopharyngitis | |
| 121735083 | 12173508 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 121735083 | 12173508 | 1 | 201404 | 201405 | 0 | |
| 121735083 | 12173508 | 2 | 201405 | 201411 | 0 | |
| 121735083 | 12173508 | 3 | 201411 | 0 | ||
| 121735083 | 12173508 | 4 | 201604 | 201604 | 0 | |
| 121735083 | 12173508 | 5 | 20150513 | 20151006 | 0 | |
| 121735083 | 12173508 | 6 | 20111101 | 20140423 | 0 | |
| 121735083 | 12173508 | 7 | 20150206 | 0 | ||
| 121735083 | 12173508 | 8 | 20140703 | 20151006 | 0 | |
| 121735083 | 12173508 | 9 | 20140504 | 20151006 | 0 | |
| 121735083 | 12173508 | 10 | 20140422 | 20140423 | 0 | |
| 121735083 | 12173508 | 11 | 20140422 | 20140423 | 0 | |
| 121735083 | 12173508 | 12 | 20140411 | 0 | ||
| 121735083 | 12173508 | 13 | 20121101 | 20140423 | 0 | |
| 121735083 | 12173508 | 14 | 20111001 | 20140519 | 0 |