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COSELA: Integrated safety analysis
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COSELA: Integrated safety analysis
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COSELA: Integrated safety analysis

Adverse reactions in ≥5% of patients with ES-SCLC receiving COSELA

(with ≥2% higher incidence with COSELA compared to the chemotherapy regimens group)

Adverse Reactions1

  • The adverse reaction summary here presents pooled safety results from Studies 1, 2, and 3. The patients included in the pooling are those randomized patients who received at least 1 dose of COSELA (122 patients) or placebo (118)
  • Serious adverse reactions occurred in 30% of patients receiving COSELA. Serious adverse reactions reported in >3% of patients who received COSELA included respiratory failure, hemorrhage, and thrombosis
  • Permanent discontinuation due to an adverse reaction occurred in 9% of patients who received COSELA
ES-SCLC=extensive-stage small cell lung cancer.

Laboratory-related adverse reactions reported in this table represent a combined analysis of laboratory parameters and any reported laboratory-related adverse reactions.

a
Graded per NCI CTCAEv4.03x.
b
Hypocalcemia=calcium decreased (lab) or treatment-emergent adverse event (TEAE) preferred term “hypocalcemia.”
c
Hypokalemia=potassium decreased (lab) or TEAE-preferred terms “hypokalemia,” “blood potassium decreased.”
d
Hypophosphatemia=phosphate decreased (lab) or TEAE-preferred terms “hypophosphatemia,” “blood phosphorus decreased.”
e
Aspartate aminotransferase increased=aspartate aminotransferase increased (lab) or TEAE-preferred term “blood aspartate aminotransferase increased.”