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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127381001 | 12738100 | 1 | I | 20101019 | 0 | 20160912 | 20160912 | DIR | FDA-CTU | 19.00 | YR | M | N | 75.80000 | KG | 20160912 | N | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127381001 | 12738100 | 1 | PS | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | Oral | ONE 8-2 MG TABLET | Y | 0 | 1 | DF | COATED TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127381001 | 12738100 | 1 | Drug dependence |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127381001 | 12738100 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127381001 | 12738100 | Diarrhoea | |
| 127381001 | 12738100 | Dyspnoea | |
| 127381001 | 12738100 | Headache | |
| 127381001 | 12738100 | Rash | |
| 127381001 | 12738100 | Reaction to drug excipients |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | CASEID | RPSR COD |
|---|---|---|
| 127381001 | 12738100 | HP |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 127381001 | 12738100 | 1 | 20101019 | 20101027 | 0 |