Maintenance of adequate control of hemolysis (LDH ≤1.5 × ULN)
Maintenance of adequate control of hemolysis (LDH ≤1.5 × ULN)
Maintenance of adequate control of hemolysis (LDH ≤1.5 × ULN)
Maintenance of adequate control of hemolysis (LDH ≤1.5 × ULN)
Adequate control of hemolysis (LDH ≤1.5 × ULN)
Transfusion avoidance
Not requiring red blood cell (RBC) transfusion as per protocol algorithm based on hemoglobin values
Transfusion avoidance
Not requiring red blood cell (RBC) transfusion as per protocol algorithm based on hemoglobin values
Transfusion avoidance
Not requiring red blood cell (RBC) transfusion as per protocol algorithm based on hemoglobin values
Transfusion avoidance
Not requiring red blood cell (RBC) transfusion as per protocol algorithm based on hemoglobin values
Breakthrough hemolysis (defined as LDH ≥2 × ULN [subsequent to initial achievement of LDH ≤1.5 × ULN] concomitant with signs or symptoms associated with hemolysis)
Breakthrough hemolysis (defined as LDH ≥2 × ULN [subsequent to initial achievement of LDH ≤1.5 × ULN] concomitant with signs or symptoms associated with hemolysis)
Breakthrough hemolysis (defined as LDH ≥2 × ULN [subsequent to initial achievement of LDH ≤1.5 × ULN] concomitant with signs or symptoms associated with hemolysis)
Breakthrough hemolysis (defined as LDH ≥2 × ULN [subsequent to initial achievement of LDH ≤1.5 × ULN] concomitant with signs or symptoms associated with hemolysis)
Hemoglobin stabilization
Patients who do not receive an RBC transfusion and have no decrease in hemoglobin level of ≥2 g/dL
Hemoglobin stabilization
Patients who do not receive an RBC transfusion and have no decrease in hemoglobin level of ≥2 g/dL
Hemoglobin stabilization
Patients who do not receive an RBC transfusion and have no decrease in hemoglobin level of ≥2 g/dL
Hemoglobin stabilization
Patients who do not receive an RBC transfusion and have no decrease in hemoglobin level of ≥2 g/dL
Change in fatigue
Measured by the FACIT-Fatigue scale The FACIT-F is a 13-item, self-reported PRO measure assessing an individual's level of fatigue during their usual daily activities over the past week. This questionnaire is part of the FACIT measurement system, a compilation of questions measuring health-related QoL in patients with cancer and other chronic illnesses. The FACIT-fatigue assesses the level of fatigue using a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Scores range from 0 to 52, with higher scores indicating greater fatigue.
Change in fatigue
Measured by the FACIT-Fatigue scale The FACIT-F is a 13-item, self-reported PRO measure assessing an individual's level of fatigue during their usual daily activities over the past week. This questionnaire is part of the FACIT measurement system, a compilation of questions measuring health-related QoL in patients with cancer and other chronic illnesses. The FACIT-fatigue assesses the level of fatigue using a 4-point Likert scale ranging from 0 (not at all) to 4 (very much). Scores range from 0 to 52, with higher scores indicating greater fatigue.
Change in fatigue
Measured by the FACIT-Fatigue scale The FACIT-F is a 13-item, self-reported PRO measure assessing an individual's level of fatigue during their usual daily activities over the past week. This questionnaire is part of the FACIT measurement system, a compilation of questions measuring health-related QoL in patients with cancer and other chronic illnesses. The FACIT-fatigue assesses the level of fatigue using a 4-point Likert scale ranging from 0 (not at all) to 4 (very much). Scores range from 0 to 52, with higher scores indicating greater fatigue.
Change in fatigue
Measured by the FACIT-Fatigue scale The FACIT-F is a 13-item, self-reported PRO measure assessing an individual's level of fatigue during their usual daily activities over the past week. This questionnaire is part of the FACIT measurement system, a compilation of questions measuring health-related QoL in patients with cancer and other chronic illnesses. The FACIT-fatigue assesses the level of fatigue using a 4-point Likert scale ranging from 0 (not at all) to 4 (very much). Scores range from 0 to 52, with higher scores indicating greater fatigue.
Change in physical function (PF) scores on the EORTC QLQ-C30
EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire)
EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
Change in PF scores on the EORTC QLQ-C30
EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire)
EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
Change in PF scores on the EORTC QLQ-C30
EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire)
EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
Change in PF scores on the EORTC QLQ-C30
EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire)
EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
Change in GHS/quality of life (QOL) scale on the EORTC QLQ-C30
GHS/QoL (Global Health Status/ Quality of Life)
Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
Change in GHS/quality of life (QOL) scale on the EORTC QLQ-C30
GHS/QoL (Global Health Status/ Quality of Life)
Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
Change in GHS/quality of life (QOL) scale on the EORTC QLQ-C30
GHS/QoL (Global Health Status/ Quality of Life)
Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
Change in GHS/quality of life (QOL) scale on the EORTC QLQ-C30
GHS/QoL (Global Health Status/ Quality of Life)
Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
Rate of red blood cell (RBC) transfusion
Per protocol algorithm
Rate of RBC transfusion
Per protocol algorithm
Rate of RBC transfusion
Per protocol algorithm
Rate of RBC transfusion
Per protocol algorithm
Number of units of RBC transfusion
Per protocol algorithm
Number of units of RBC transfusion
Per protocol algorithm
Number of units of RBC transfusion
Per protocol algorithm
Number of units of RBC transfusion
Per protocol algorithm
Percentage of days with LDH ≤1.5x upper limit of normal (ULN)
Percentage of days with LDH ≤1.5x ULN
Percentage of days with LDH ≤1.5x ULN
Percentage of days with LDH ≤1.5x ULN
Change in hemoglobin levels
Change in hemoglobin levels
Change in hemoglobin levels
Change in hemoglobin levels
Change in total complement hemolytic activity assay (CH50)
Concentrations of total pozelimab in serum
Concentrations of cemdisiran in plasma
Incidence of treatment-emergent anti-drug antibodies to pozelimab
Incidence of treatment-emergent anti-drug antibodies to cemdisiran
Concentration of total complement component 5 (C5) in plasma
Percent change of concentration of total C5 in plasma