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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127710231 | 12771023 | 1 | I | 20160915 | 0 | 20160921 | 20160921 | DIR | US-FDA-351240 | FDA-CTU | 11.00 | YR | F | N | 0.00000 | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127710231 | 12771023 | 1 | PS | ATROVENT HFA | IPRATROPIUM BROMIDE | 1 | Respiratory (inhalation) | D | D | 0 | BID | ||||||||
| 127710231 | 12771023 | 2 | SS | CREON | PANCRELIPASE AMYLASEPANCRELIPASE LIPASEPANCRELIPASE PROTEASE | 1 | Oral | OTHER STRENGTH:;OTHER DOSE:;OTHER FREQUENCY:W/MEALS/SNACKS;OTHER ROUTE: | D | D | 0 | ||||||||
| 127710231 | 12771023 | 3 | SS | PROAIR HFA | ALBUTEROL SULFATE | 1 | Respiratory (inhalation) | D | D | 0 | PRN | ||||||||
| 127710231 | 12771023 | 4 | SS | PULMOZYME | DORNASE ALFA | 1 | Respiratory (inhalation) | D | D | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127710231 | 12771023 | 1 | Cystic fibrosis |
| 127710231 | 12771023 | 2 | Cystic fibrosis |
| 127710231 | 12771023 | 3 | Cystic fibrosis |
| 127710231 | 12771023 | 4 | Cystic fibrosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127710231 | 12771023 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127710231 | 12771023 | Pneumonia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | CASEID | RPSR COD |
|---|---|---|
| 127710231 | 12771023 | HP |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 127710231 | 12771023 | 1 | 20150313 | 0 | ||
| 127710231 | 12771023 | 2 | 20150210 | 0 | ||
| 127710231 | 12771023 | 3 | 20151007 | 0 | ||
| 127710231 | 12771023 | 4 | 20150210 | 0 |