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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127526001 | 12752600 | 1 | I | 0 | 20160916 | 20160916 | DIR | US-FDA-350809 | FDA-CTU | 13.00 | YR | F | N | 0.00000 | 20160916 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127526001 | 12752600 | 1 | PS | CREON | PANCRELIPASE AMYLASEPANCRELIPASE LIPASEPANCRELIPASE PROTEASE | 1 | Oral | OTHER ORAL | D | D | 0 | ||||||||
| 127526001 | 12752600 | 2 | SS | DULERA | FORMOTEROL FUMARATE DIHYDRATEMOMETASONE FUROATE | 1 | Respiratory (inhalation) | D | D | 0 | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127526001 | 12752600 | 1 | Cystic fibrosis |
| 127526001 | 12752600 | 2 | Cystic fibrosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127526001 | 12752600 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127526001 | 12752600 | Death |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | CASEID | RPSR COD |
|---|---|---|
| 127526001 | 12752600 | HP |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 127526001 | 12752600 | 1 | 20151201 | 0 | ||
| 127526001 | 12752600 | 2 | 20150917 | 0 |