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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125959381 | 12595938 | 1 | I | 20150204 | 20160419 | 20160726 | 20160726 | PER | US-OREXO US, INC.-ORE201604-000058 | OREXO | 51.00 | YR | M | Y | 108.96000 | KG | 20160726 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125959381 | 12595938 | 1 | PS | ZUBSOLV | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | Sublingual | 5.7 MG/1.4MG HALF TABLET TWO TIMES A DAY | Y | 204242 | .5 | DF | TABLET | ||||||
125959381 | 12595938 | 2 | SS | BUPRENORPHINE / NALOXONE DIHYDRATE | BUPRENORPHINENALOXONE | 1 | 0 | ||||||||||||
125959381 | 12595938 | 3 | SS | SUBUTEX | BUPRENORPHINE HYDROCHLORIDE | 1 | Y | 0 | 8 | MG | BID |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125959381 | 12595938 | 1 | Drug dependence |
125959381 | 12595938 | 2 | Drug dependence |
125959381 | 12595938 | 3 | Drug dependence |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125959381 | 12595938 | Nausea | |
125959381 | 12595938 | Oedema peripheral | |
125959381 | 12595938 | Vomiting |
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 |
---|---|---|---|---|---|---|
125959381 | 12595938 | 1 | 20150203 | 20150205 | 0 | |
125959381 | 12595938 | 2 | 20150205 | 20150207 | 0 | |
125959381 | 12595938 | 3 | 20150225 | 20150225 | 0 |