Registered outcomes11

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

1 to 11 of 11

List	Outcome	Time frame	Description
Primary	The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type	2 years	To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.
Primary	The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 6.0).	2 years	To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.
Primary	The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.	2 years	To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.
Primary	The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.	2 years	To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.
Primary	The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by the relationship to study treatment.	2 years	To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.
Secondary	The proportion of subjects who achieve >50% reduction in JAK2 V617F mutation burden.	2 years	To assess the incidence of patients who achieve \>50% reduction in JAK2 V617F mutation burden.
Secondary	Change in JAK2, CALR, MPL mutations allelic burden.	2 years	To assess the rate of reduction of JAK2, CALR, MPL mutations allelic burden.
Secondary	The proportion of subjects who achieve a 25% decrease in spleen volume by 24 weeks from initiation of combination treatment.	24 weeks	To assess the rate of 25% spleen volume reduction at 24 weeks of the combination (Abdominal MRI will be done for spleen size measurement).
Secondary	Change in quality of life Myeloproliferative Neoplasm (MPN) Symptom Questionnaire from baseline and throughout treatment.	2 years	To assess the change in the quality of life MPN Symptom Questionnaire score. The MPN Symptom questionnaire consists of 10 questions asking patients to rate their symptoms on a scale of 1 to 10, with 0 being no symptoms and 10 being the worst symptoms.
Secondary	The proportion of subjects who progress to blastic phase and secondary acute myeloid leukemia at 2 years post-treatment.	2 years	To assess the rate of blastic transformation.
Secondary	The proportion of subjects who have a change in bone marrow fibrosis grade.	2 years	To assess the rate of change in myelofibrosis (MF) grade (MF grade 0 to 3, the higher the worse).

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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