Neutropenias
Conditions
Brief summary
Annualized infection rate based on infections adjudicated by a BIAC during the 52-week treatment period, 2a: Proportion of ANC responders. An ANC responder is a participant meeting the definition of a positive ANC response for at least 3 out of 6 visits [Weeks 4, 8, 13, 26, 39, and 52] during the 52-week treatment period, where a positive ANC response is defined as: (please see next "ID 3"), 2b: (continued from ID 2) • ANC ≥ 1500 cells/µL, with the exception of participants with baseline ANC < 500 cells/µL • ≥ 2-fold increase in ANC from baseline, for participants with baseline ANC < 500 cells/µL
Detailed description
Infection severity based on CTCAE grading, adjudicated by a BIAC during the 52-week treatment period, Infection duration based on duration of infections adjudicated by a BIAC during the 52-week treatment period, Antibiotic use due to infection, characterized by the frequency of antibiotic use during the 52-week treatment period, Oral ulcers, as assessed by presence or absence of ulcers, during the 52-week treatment period, Change from baseline to Week 52/Day 365 in PROMIS SF Fatigue Questionnaire total score
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized infection rate based on infections adjudicated by a BIAC during the 52-week treatment period, 2a: Proportion of ANC responders. An ANC responder is a participant meeting the definition of a positive ANC response for at least 3 out of 6 visits [Weeks 4, 8, 13, 26, 39, and 52] during the 52-week treatment period, where a positive ANC response is defined as: (please see next "ID 3"), 2b: (continued from ID 2) • ANC ≥ 1500 cells/µL, with the exception of participants with baseline ANC < 500 cells/µL • ≥ 2-fold increase in ANC from baseline, for participants with baseline ANC < 500 cells/µL | — |
Secondary
| Measure | Time frame |
|---|---|
| Infection severity based on CTCAE grading, adjudicated by a BIAC during the 52-week treatment period, Infection duration based on duration of infections adjudicated by a BIAC during the 52-week treatment period, Antibiotic use due to infection, characterized by the frequency of antibiotic use during the 52-week treatment period, Oral ulcers, as assessed by presence or absence of ulcers, during the 52-week treatment period, Change from baseline to Week 52/Day 365 in PROMIS SF Fatigue Questionnaire total score | — |
Countries
Belgium, Czechia, France, Germany, Greece, Hungary, Ireland, Italy, Poland, Portugal, Romania, Spain