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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125500571 | 12550057 | 1 | I | 2016 | 20160707 | 20160712 | 20160712 | EXP | US-VERTEX PHARMACEUTICALS-2016-004247 | VERTEX | 0.00 | M | Y | 0.00000 | 20160712 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125500571 | 12550057 | 1 | PS | KALYDECO | IVACAFTOR | 1 | Oral | UNK | 203188 | TABLET | |||||||||
| 125500571 | 12550057 | 2 | SS | ANTIBIOTICS | UNSPECIFIED INGREDIENT | 1 | Intravenous (not otherwise specified) | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125500571 | 12550057 | 1 | Cystic fibrosis |
| 125500571 | 12550057 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125500571 | 12550057 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125500571 | 12550057 | Drug hypersensitivity | |
| 125500571 | 12550057 | Lower respiratory tract infection bacterial |
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 |
|---|---|---|---|---|---|---|
| 125500571 | 12550057 | 1 | 20151120 | 0 |