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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100279503 | 10027950 | 3 | F | 20140926 | 20140321 | 20140930 | EXP | GB-VERTEX PHARMACEUTICALS INC-2014-000529 | VERTEX | 0.00 | M | Y | 0.00000 | 20140930 | N | CN | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100279503 | 10027950 | 1 | PS | KALYDECO | IVACAFTOR | 1 | UNKNOWN | 150 MG, BID | D | 203188 | 150 | MG | TABLET | Q12H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 100279503 | 10027950 | 1 | Cystic fibrosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 100279503 | 10027950 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 100279503 | 10027950 | Malaise | |
| 100279503 | 10027950 | Memory impairment |
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 |
|---|---|---|---|---|---|---|
| 100279503 | 10027950 | 1 | 20130507 | 0 |