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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124419873 | 12441987 | 3 | F | 20130828 | 20160805 | 20160607 | 20160811 | EXP | US-VERTEX PHARMACEUTICALS-2016-003553 | VERTEX | 17.00 | YR | F | Y | 0.00000 | 20160811 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124419873 | 12441987 | 1 | PS | KALYDECO | IVACAFTOR | 1 | Oral | 150 MG, BID | Y | 203188 | 150 | MG | TABLET | Q12H | |||||
| 124419873 | 12441987 | 2 | SS | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | UNK | Y | U | 0 | ||||||||
| 124419873 | 12441987 | 3 | C | ALBUTEROL. | ALBUTEROL | 1 | Respiratory (inhalation) | 2 PUFF, BID | U | 0 | Q12H | ||||||||
| 124419873 | 12441987 | 4 | C | CREON | PANCRELIPASE AMYLASEPANCRELIPASE LIPASEPANCRELIPASE PROTEASE | 1 | Oral | 2 CAPSULES WITH MEAL AND ONE WITH SNACKS | U | 0 | CAPSULE | ||||||||
| 124419873 | 12441987 | 5 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | 10 MG, QHS | U | 0 | 10 | MG | ||||||||
| 124419873 | 12441987 | 6 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | SPRAY, QHS | U | 0 | ||||||||||
| 124419873 | 12441987 | 7 | C | HYPERSAL | 2 | Respiratory (inhalation) | 4 ML, BID | U | 0 | 4 | ML | Q12H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124419873 | 12441987 | 1 | Cystic fibrosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124419873 | 12441987 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124419873 | 12441987 | Bone marrow failure | |
| 124419873 | 12441987 | Headache | |
| 124419873 | 12441987 | Infective pulmonary exacerbation of cystic fibrosis | |
| 124419873 | 12441987 | Pyrexia | |
| 124419873 | 12441987 | Rash | |
| 124419873 | 12441987 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 124419873 | 12441987 | 1 | 20120419 | 2016 | 0 | |
| 124419873 | 12441987 | 2 | 2016 | 0 |