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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127801671 | 12780167 | 1 | I | 0 | 20160923 | 20160923 | DIR | US-FDA-351427 | FDA-CTU | 35.00 | YR | F | N | 0.00000 | 20160923 | N | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127801671 | 12780167 | 1 | PS | CREON | PANCRELIPASE AMYLASEPANCRELIPASE LIPASEPANCRELIPASE PROTEASE | 1 | Oral | 24,000 UNITS ORAL | D | D | 0 | 24000 | DF | ||||||
127801671 | 12780167 | 2 | SS | PULMOZYME | DORNASE ALFA | 1 | Respiratory (inhalation) | D | D | 0 | BID |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
127801671 | 12780167 | 1 | Cystic fibrosis |
127801671 | 12780167 | 2 | Cystic fibrosis |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
127801671 | 12780167 | HO |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
127801671 | 12780167 | Abdominal pain |
Reporting Sources (this data is often not reported and may therefore be missing here)
Event ID | CASEID | RPSR COD |
---|---|---|
127801671 | 12780167 | HP |
Therapies reported
Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
---|---|---|---|---|---|---|
127801671 | 12780167 | 1 | 20150703 | 0 | ||
127801671 | 12780167 | 2 | 20150605 | 0 |