Skip to main content
Clinical trial efficacy data
Navbar Image
Clinical trial efficacy data
This site is intended only for US healthcare professionals.

Clinical trial efficacy data

Reduced risk of thrombocytopenia in clinical trials1-3

  • Fewer platelet-related events from chemotherapy in patients receiving COSELA in clinical trials, including1-3:
    • Grade 3/4 thrombocytopenia (secondary and exploratory endpoints, hematologic adverse event)
    • Platelet transfusions (in the Pivotal and Study 3 only as secondary endpoints)
  • In treatment groups receiving COSELA permanent discontinuation due to an adverse reaction occurred in 9% of patients and included thrombocytopenia, cerebrovascular accident, and ischemic stroke (<1% each)
1L=first-line; 2L=second-line; 3L=third-line.
a
Results for platelet endpoints including incidence of Grade 3/4 thrombocytopenia and platelet transfusions were not consistent across COSELA clinical trials.
b
P value not adjusted for multiplicity; (P=0.0026) adjusted relative risk=0.053 (95% CI; 0.008, 0.356).1
c
Study 2 was a proof-of-concept study with the primary objectives of assessing safety and tolerability; efficacy objectives were secondary or exploratory.2
d
Data was reported as a treatment-emergent adverse event and included placebo (8% [3/37]) and COSELA (8% [3/38]).2
e
Data from clinical study publication: placebo, 0% (0/37); COSELA, 5% (2/38).2
f
Data was reported as a treatment-emergent adverse event and included placebo (57.1% [16/28]) and COSELA (53.1% [17/32]).3
*
Indicates statistical significance.