Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 14 of 14

List	Outcome	Time frame	Description
Primary	Change From Baseline in Hgb at Week 12	Baseline, Week 12	Hgb baseline was defined as the lowest Hgb value observed between and including screening and first dose date. To address the impact of transfusion, Hgb values collected within 4 weeks after transfusion were not included in the primary efficacy analysis. Change from Baseline = Hgb at Week 12 - Baseline Hgb.
Secondary	Number of Participants Who Had Transfusion Avoidance During 12 Weeks of Treatment With ALXN2050	Baseline up to Week 12	Transfusion avoidance: participants remained transfusion-free and did not require a transfusion during the period of interest.
Secondary	Number of Red Blood Cell (RBC) Units Transfused During 12 Weeks of Treatment	Baseline up to Week 12
Secondary	Number of Transfusion Instances During 12 Weeks of Treatment	Baseline up to Week 12
Secondary	Change From Baseline in Lactate Dehydrogenase (LDH) at Week 12	Baseline, Week 12	Change from Baseline = Serum LDH levels at Week 12 - Baseline Serum LDH levels.
Secondary	Change From Baseline in Absolute Reticulocyte Count at Week 12	Baseline, Week 12	Change from Baseline = absolute reticulocyte count at Week 12 - Baseline reticulocyte count.
Secondary	Change From Baseline in Direct and Total Bilirubin at Week 12	Baseline, Week 12
Secondary	Change From Baseline in Paroxysmal Nocturnal Hemoglobinuria (PNH) Red Blood Cell (RBC) Clone Size at Week 12	Baseline, Week 12	The PNH RBC clone size refers to the percentage of PNH-affected cells versus normal cells within the total cell population. Change from Baseline = PNH clone size at Week 12 - Baseline PNH clone size.
Secondary	Change From Baseline in Component 3 (C3) Fragment Deposition on PNH RBCs at Week 12	Baseline, Week 12	C3 fragment deposition on PNH RBC was used as a marker of intra and extravascular hemolysis. Data are presented for the change from baseline to Week 12 in percentage of PNH RBCs with C3 fragment deposition.
Secondary	Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Events Leading to Discontinuation of Study Medication	From first dose of study drug up to Week 217	An adverse event (AE) was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), or an important medical event or reaction. A TEAE was defined as an AE that emerged during treatment, had been absent prior to treatment, or worsened relative to the pretreatment state. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Secondary	Change From Baseline in Hgb at the End of Treatment (EOT) During the LTE Period	Baseline, EOT visit (Maximum exposure: 213.4 weeks)	Hgb baseline was defined as the lowest Hgb value observed between and including screening and first dose date. Change from Baseline = Hgb at the EOT visit - Baseline Hgb.
Secondary	Change From Baseline in LDH at the EOT During the LTE Period	Baseline, EOT visit (Maximum exposure: 213.4 weeks)	Change from Baseline = Serum LDH levels at the EOT visit - Baseline Serum LDH levels.
Secondary	Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (Version 4) Total Score at Week 12	Baseline, Week 12	The FACIT-Fatigue scale is a collection of quality-of-life questionnaires pertaining to the management of fatigue symptoms due to chronic illness. The FACIT-Fatigue is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the preceding 7 days. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). Total scores ranged from 0 to 52, with higher score indicating better quality of life.
Secondary	Change From Baseline in FACIT-Fatigue Scale (Version 4) Total Score at the EOT During the LTE Period	Baseline, EOT visit (Maximum exposure: 213.4 weeks)	The FACIT-Fatigue scale is a collection of quality-of-life questionnaires pertaining to the management of fatigue symptoms due to chronic illness. The FACIT-Fatigue is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the preceding 7 days. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). Total scores ranged from 0 to 52, with higher score indicating better quality of life.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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