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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114808812 | 11480881 | 2 | F | 20160909 | 20150909 | 20160919 | PER | US-JAZZ-2014-US-015748 | JAZZ | 0.00 | M | Y | 118.82000 | KG | 20160919 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114808812 | 11480881 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 114808812 | 11480881 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 114808812 | 11480881 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 114808812 | 11480881 | 4 | SS | MINOCYCLINE | MINOCYCLINEMINOCYCLINE HYDROCHLORIDE | 1 | N | 0 | |||||||||||
| 114808812 | 11480881 | 5 | C | ARMOUR THYROID | THYROID, PORCINE | 1 | Oral | 60 MG, QD | U | 0 | 60 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114808812 | 11480881 | 1 | Sleep disorder |
| 114808812 | 11480881 | 4 | Product used for unknown indication |
| 114808812 | 11480881 | 5 | Hypothyroidism |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114808812 | 11480881 | Anxiety | |
| 114808812 | 11480881 | Blood viscosity abnormal | |
| 114808812 | 11480881 | Dizziness | |
| 114808812 | 11480881 | Fatigue | |
| 114808812 | 11480881 | Headache | |
| 114808812 | 11480881 | Product use issue | |
| 114808812 | 11480881 | Skin discolouration |
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 |
|---|---|---|---|---|---|---|
| 114808812 | 11480881 | 1 | 201203 | 0 | ||
| 114808812 | 11480881 | 2 | 201408 | 2014 | 0 | |
| 114808812 | 11480881 | 3 | 2014 | 0 |