NCT01969838 · STUDY IN CONTEXT

Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Splenic response rate at Week 24 is defined as the percentage of participants who achieved a spleen volume reduction of ≥ 35% from baseline at the Week 24 assessment as measured by MRI or CT.

Source null

→

secondary · POSTED

Total symptom score (TSS) is defined as the percentage of participants who achieved a ≥50% reduction in TSS at Week 24 versus baseline as measured by the modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) v2.0 diary. Response rate was calculated using the average of the daily TSS from a consecutive 28-day period prior to Week 24, which had ≥20 daily TSS available. The modified MPN-SAF patient-reported outcome instrument consisted of 8 items assessing worst daily incidence of tiredness, filling up quickly, abdominal discomfort, night sweats, itching, bone pain, pain under ribs on left side, and inactivity. Scoring of the Total Symptom Score (TSS), in this study was based on 7 of these items, (range of 0-70,), excluding inactivity. These items assess the impact experienced by the participant in the 24 hours prior to completing the questionnaire. All items are measured using a 0 to 10 Numeric Rating Scale, with 0 corresponding to "Absent" and 10 being the worse

TSS rate analysis at Week 24 only included participants with TSS \> 0 at baseline or with TSS = 0 at baseline but with TSS \> 0 or missing at Week 24.

→

secondary · POSTED

Rate of RBC transfusion was defined as the average number of RBC units transfused not associated with clinically overt bleeding per subject-month during the double-blind phase.

Source null

→

secondary · POSTED

RBC transfusion independence is the percentage of participants who are transfusion independent at Week 24, defined as absence of RBC transfusions and no hemoglobin level below 8 g/dL in the 12 weeks prior to Week 24, excluding cases associated with clinically overt bleeding.

Source null

→

secondary · POSTED

RBC transfusion dependence is the percentage of participants who are transfusion dependent at Week 24, defined as having had at least 4 units of RBC transfusions, or a hemoglobin level below 8 g/dL in 8 weeks prior to Week 24 (excluding cases associated with clinically overt bleeding). Participants with the last double-blind phase participation date prior to Day 162 (ie. missing at Week 24) were considered transfusion dependent at Week 24.

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

Patient-reported symptom or function measure · Total Symptom Score (TSS) Response Rate at Week 24

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-myeloid-neoplasm
nct id: NCT01969838
qol key: qol-0001
source section id: NCT01969838-om-0001
source outcome index: 1
instrument: Patient-reported symptom or function measure
instrument basis: matched 'symptom score' in the study's own wording
scale title: Total Symptom Score (TSS) Response Rate at Week 24
measure definition: Total symptom score (TSS) is defined as the percentage of participants who achieved a ≥50% reduction in TSS at Week 24 versus baseline as measured by the modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) v2.0 diary. Response rate was calculated using the average of the daily TSS from a consecutive 28-day period prior to Week 24, which had ≥20 daily TSS available. The modified MPN-SAF patient-reported outcome instrument consisted of 8 items assessing worst daily incidence of tiredness, filling up quickly, abdominal discomfort, night sweats, itching, bone pain, pain under ribs on left side, and inactivity. Scoring of the Total Symptom Score (TSS), in this study was based on 7 of these items, (range of 0-70,), excluding inactivity. These items assess the impact experienced by the participant in the 24 hours prior to completing the questionnaire. All items are measured using a 0 to 10 Numeric Rating Scale, with 0 corresponding to "Absent" and 10 being the worse
time frame: Week 24
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: TSS rate analysis at Week 24 only included participants with TSS \> 0 at baseline or with TSS = 0 at baseline but with TSS \> 0 or missing at Week 24.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-myeloid-neoplasm
nct id: NCT01969838
trial label: Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 5
harms Count: 4
qol Count: 1

outcomes

release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01969838
outcome key
om-0000
source section id
NCT01969838-om-0000
source outcome index
0
endpoint
Splenic Response Rate at Week 24
endpoint definition
Splenic response rate at Week 24 is defined as the percentage of participants who achieved a spleen volume reduction of ≥ 35% from baseline at the Week 24 assessment as measured by MRI or CT.
time origin
Week 24
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01969838
outcome key
om-0001
source section id
NCT01969838-om-0001
source outcome index
1
endpoint
Total Symptom Score (TSS) Response Rate at Week 24
endpoint definition
Total symptom score (TSS) is defined as the percentage of participants who achieved a ≥50% reduction in TSS at Week 24 versus baseline as measured by the modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) v2.0 diary. Response rate was calculated using the average of the daily TSS from a consecutive 28-day period prior to Week 24, which had ≥20 daily TSS available. The modified MPN-SAF patient-reported outcome instrument consisted of 8 items assessing worst daily incidence of tiredness, filling up quickly, abdominal discomfort, night sweats, itching, bone pain, pain under ribs on left side, and inactivity. Scoring of the Total Symptom Score (TSS), in this study was based on 7 of these items, (range of 0-70,), excluding inactivity. These items assess the impact experienced by the participant in the 24 hours prior to completing the questionnaire. All items are measured using a 0 to 10 Numeric Rating Scale, with 0 corresponding to "Absent" and 10 being the worse
time origin
Week 24
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
TSS rate analysis at Week 24 only included participants with TSS \> 0 at baseline or with TSS = 0 at baseline but with TSS \> 0 or missing at Week 24.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01969838
outcome key
om-0002
source section id
NCT01969838-om-0002
source outcome index
2
endpoint
Rate of Red Blood Cell (RBC) Transfusions in the Double-blind Phase, (the Average Number of RBC Units Transfused Per Month Not Associated With Overt Bleeding)
endpoint definition
Rate of RBC transfusion was defined as the average number of RBC units transfused not associated with clinically overt bleeding per subject-month during the double-blind phase.
time origin
Baseline to Week 24
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01969838
outcome key
om-0003
source section id
NCT01969838-om-0003
source outcome index
3
endpoint
RBC Transfusion Independence Rate at Week 24, (Defined as Absence of RBC Transfusions and no Hemoglobin Level Below 8 g/dL in the 12 Weeks Prior to Week 24, Excluding Cases Associated With Clinically Overt Bleeding)
endpoint definition
RBC transfusion independence is the percentage of participants who are transfusion independent at Week 24, defined as absence of RBC transfusions and no hemoglobin level below 8 g/dL in the 12 weeks prior to Week 24, excluding cases associated with clinically overt bleeding.
time origin
Week 24
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01969838
outcome key
om-0004
source section id
NCT01969838-om-0004
source outcome index
4
endpoint
RBC Transfusion Dependence Rate at Week 24. (Defined as Having Had at Least 4 Units of RBC Transfusions, or a Hemoglobin Level Below 8 g/dL in 8 Weeks Prior to Week 24 (Excluding Cases Associated With Clinically Overt Bleeding)).
endpoint definition
RBC transfusion dependence is the percentage of participants who are transfusion dependent at Week 24, defined as having had at least 4 units of RBC transfusions, or a hemoglobin level below 8 g/dL in 8 weeks prior to Week 24 (excluding cases associated with clinically overt bleeding). Participants with the last double-blind phase participation date prior to Day 162 (ie. missing at Week 24) were considered transfusion dependent at Week 24.
time origin
Week 24
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01969838
outcome key
om-0000
arm key
OG000
arm label
Momelotinib (MMB)
regimen
Participants received momelotinib plus placebo to match ruxolitinib. Momelotinib tablets were administered orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg. Placebo to match ruxolitinib tablets were administered orally twice daily.
analyzed count
215
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01969838-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01969838
outcome key
om-0000
arm key
OG001
arm label
Ruxolitinib (RUX)
regimen
Participants received ruxolitinib plus placebo to match momelotinib. Ruxolitinib tablets were administered orally twice daily. The dose ranged from 5 to 20 mg BID and was dependent on platelet count, creatinine clearance, and transaminase levels. Placebo to match momelotinib tablets were administered orally once daily.
analyzed count
217
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01969838-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01969838
outcome key
om-0001
arm key
OG000
arm label
Momelotinib (MMB)
regimen
Participants received momelotinib plus placebo to match ruxolitinib. Momelotinib tablets were administered orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg. Placebo to match ruxolitinib tablets were administered orally twice daily.
analyzed count
211
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01969838-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01969838
outcome key
om-0001
arm key
OG001
arm label
Ruxolitinib (RUX)
regimen
Participants received ruxolitinib plus placebo to match momelotinib. Ruxolitinib tablets were administered orally twice daily. The dose ranged from 5 to 20 mg BID and was dependent on platelet count, creatinine clearance, and transaminase levels. Placebo to match momelotinib tablets were administered orally once daily.
analyzed count
211
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01969838-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01969838
outcome key
om-0002
arm key
OG000
arm label
Momelotinib (MMB)
regimen
Participants received momelotinib plus placebo to match ruxolitinib. Momelotinib tablets were administered orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg. Placebo to match ruxolitinib tablets were administered orally twice daily.
analyzed count
215
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01969838-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01969838
outcome key
om-0002
arm key
OG001
arm label
Ruxolitinib (RUX)
regimen
Participants received ruxolitinib plus placebo to match momelotinib. Ruxolitinib tablets were administered orally twice daily. The dose ranged from 5 to 20 mg BID and was dependent on platelet count, creatinine clearance, and transaminase levels. Placebo to match momelotinib tablets were administered orally once daily.
analyzed count
217
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01969838-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01969838
outcome key
om-0003
arm key
OG000
arm label
Momelotinib (MMB)
regimen
Participants received momelotinib plus placebo to match ruxolitinib. Momelotinib tablets were administered orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg. Placebo to match ruxolitinib tablets were administered orally twice daily.
analyzed count
215
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01969838-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01969838
outcome key
om-0003
arm key
OG001
arm label
Ruxolitinib (RUX)
regimen
Participants received ruxolitinib plus placebo to match momelotinib. Ruxolitinib tablets were administered orally twice daily. The dose ranged from 5 to 20 mg BID and was dependent on platelet count, creatinine clearance, and transaminase levels. Placebo to match momelotinib tablets were administered orally once daily.
analyzed count
217
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01969838-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01969838
outcome key
om-0004
arm key
OG000
arm label
Momelotinib (MMB)
regimen
Participants received momelotinib plus placebo to match ruxolitinib. Momelotinib tablets were administered orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg. Placebo to match ruxolitinib tablets were administered orally twice daily.
analyzed count
215
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01969838-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01969838
outcome key
om-0004
arm key
OG001
arm label
Ruxolitinib (RUX)
regimen
Participants received ruxolitinib plus placebo to match momelotinib. Ruxolitinib tablets were administered orally twice daily. The dose ranged from 5 to 20 mg BID and was dependent on platelet count, creatinine clearance, and transaminase levels. Placebo to match momelotinib tablets were administered orally once daily.
analyzed count
217
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01969838-om-0004#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01969838
harm key
EG000
source section id
NCT01969838-ae
event group key
EG000
event group label
Momelotinib (MMB)
serious affected
49
serious at risk
214
other affected
197
other at risk
214
frequency threshold
5
collection period
Serious and other Adverse events were recorded that occurred from initiation of investigational product (IP) until 30 days after the last administration of IP regardless of cause or relationship. Serious events are monitored up to 12 weeks and all-cause mortality was assessed for up to 5 years.
event definition
The safety population did not include 2 patients (one on MMB and one on RUX) who were not dosed, hence affecting the total number of patients at risk.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01969838
harm key
EG001
source section id
NCT01969838-ae
event group key
EG001
event group label
Ruxolitinib (RUX)
serious affected
39
serious at risk
216
other affected
206
other at risk
216
frequency threshold
5
collection period
Serious and other Adverse events were recorded that occurred from initiation of investigational product (IP) until 30 days after the last administration of IP regardless of cause or relationship. Serious events are monitored up to 12 weeks and all-cause mortality was assessed for up to 5 years.
event definition
The safety population did not include 2 patients (one on MMB and one on RUX) who were not dosed, hence affecting the total number of patients at risk.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01969838
harm key
EG002
source section id
NCT01969838-ae
event group key
EG002
event group label
MMB to MMB
serious affected
79
serious at risk
171
other affected
153
other at risk
171
frequency threshold
5
collection period
Serious and other Adverse events were recorded that occurred from initiation of investigational product (IP) until 30 days after the last administration of IP regardless of cause or relationship. Serious events are monitored up to 12 weeks and all-cause mortality was assessed for up to 5 years.
event definition
The safety population did not include 2 patients (one on MMB and one on RUX) who were not dosed, hence affecting the total number of patients at risk.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01969838
harm key
EG003
source section id
NCT01969838-ae
event group key
EG003
event group label
RUX to MMB
serious affected
79
serious at risk
197
other affected
188
other at risk
197
frequency threshold
5
collection period
Serious and other Adverse events were recorded that occurred from initiation of investigational product (IP) until 30 days after the last administration of IP regardless of cause or relationship. Serious events are monitored up to 12 weeks and all-cause mortality was assessed for up to 5 years.
event definition
The safety population did not include 2 patients (one on MMB and one on RUX) who were not dosed, hence affecting the total number of patients at risk.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01969838
qol key
qol-0001
source section id
NCT01969838-om-0001
source outcome index
1
instrument
Patient-reported symptom or function measure
instrument basis
matched 'symptom score' in the study's own wording
scale title
Total Symptom Score (TSS) Response Rate at Week 24
measure definition
Total symptom score (TSS) is defined as the percentage of participants who achieved a ≥50% reduction in TSS at Week 24 versus baseline as measured by the modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) v2.0 diary. Response rate was calculated using the average of the daily TSS from a consecutive 28-day period prior to Week 24, which had ≥20 daily TSS available. The modified MPN-SAF patient-reported outcome instrument consisted of 8 items assessing worst daily incidence of tiredness, filling up quickly, abdominal discomfort, night sweats, itching, bone pain, pain under ribs on left side, and inactivity. Scoring of the Total Symptom Score (TSS), in this study was based on 7 of these items, (range of 0-70,), excluding inactivity. These items assess the impact experienced by the participant in the 24 hours prior to completing the questionnaire. All items are measured using a 0 to 10 Numeric Rating Scale, with 0 corresponding to "Absent" and 10 being the worse
time frame
Week 24
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
TSS rate analysis at Week 24 only included participants with TSS \> 0 at baseline or with TSS = 0 at baseline but with TSS \> 0 or missing at Week 24.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice