Trial Outcomes & Findings for Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis (NCT NCT01969838)

NCT ID: NCT01969838

Last Updated: 2023-05-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

432 participants

Primary outcome timeframe

Week 24

Results posted on

2023-05-12

Participant Flow

432 participants were randomized at 131 centers in 22 countries.

Participants were screened within 35 days after signing the informed consent form to determine eligibility for participation in the study. Participants who were not randomized within the 35 day screening window were screen failed. At randomization, participants were randomly assigned 1:1 to MMB plus RUX-placebo or RUX plus MMB-placebo.

Participant milestones

Participant milestones
Measure	Momelotinib (MMB) 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.	Ruxolitinib (RUX) Participants received ruxolitinib plus placebo to match momelotinib. Ruxolitinib tablets were administered orally twice daily (BID). 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.	MMB to MMB After completion of the 24-week double-blind treatment phase, participants had the option to receive MMB in an open-label treatment phase for up to an additional 216 weeks. Participants randomized to the MMB group at study entry continued MMB in the open-label treatment phase at their current dose. Available MMB strengths were 100 mg, 150 mg and 200 mg.	RUX to MMB After completion of the 24-week double-blind treatment phase, participants had the option to receive MMB in an open-label treatment phase for up to an additional 216 weeks. Participants randomized to the RUX group who wished to remain in the study initiated MMB in the open-label treatment phase at the dose matching their equivalent MMB placebo dose. Available MMB strengths were 100 mg, 150 mg and 200 mg.
Double-blind Phase STARTED	215	217	0	0
Double-blind Phase COMPLETED	188	208	0	0
Double-blind Phase NOT COMPLETED	27	9	0	0
Open-label Phase STARTED	0	0	171	197
Open-label Phase COMPLETED	0	0	1	0
Open-label Phase NOT COMPLETED	0	0	170	197

Reasons for withdrawal

Reasons for withdrawal
Measure	Momelotinib (MMB) 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.	Ruxolitinib (RUX) Participants received ruxolitinib plus placebo to match momelotinib. Ruxolitinib tablets were administered orally twice daily (BID). 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.	MMB to MMB After completion of the 24-week double-blind treatment phase, participants had the option to receive MMB in an open-label treatment phase for up to an additional 216 weeks. Participants randomized to the MMB group at study entry continued MMB in the open-label treatment phase at their current dose. Available MMB strengths were 100 mg, 150 mg and 200 mg.	RUX to MMB After completion of the 24-week double-blind treatment phase, participants had the option to receive MMB in an open-label treatment phase for up to an additional 216 weeks. Participants randomized to the RUX group who wished to remain in the study initiated MMB in the open-label treatment phase at the dose matching their equivalent MMB placebo dose. Available MMB strengths were 100 mg, 150 mg and 200 mg.
Double-blind Phase Adverse Event	10	4	0	0
Double-blind Phase Death	5	2	0	0
Double-blind Phase Physician Decision	5	1	0	0
Double-blind Phase Subject Decision	4	2	0	0
Double-blind Phase Disease Progression	2	0	0	0
Double-blind Phase Symptomatic Spleen Growth	1	0	0	0
Open-label Phase Transferred to study SRA-MMB-4365	0	0	52	62
Open-label Phase Adverse Event	0	0	37	49
Open-label Phase Disease Progression	0	0	26	27
Open-label Phase Lack of Efficacy	0	0	17	19
Open-label Phase Subject Decision	0	0	14	15
Open-label Phase Death	0	0	13	11
Open-label Phase Physician Decision	0	0	9	14
Open-label Phase Non-compliance with Study Drug	0	0	2	0

Baseline Characteristics

Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Momelotinib (MMB) n=215 Participants Participants received momelotinib plus placebo to match ruxolitinib. Momelotinib: 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: Placebo to match ruxolitinib tablets were administered orally twice daily.	Ruxolitinib (RUX) n=217 Participants Participants received ruxolitinib plus placebo to match momelotinib. Ruxolitinib: 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: Placebo to match momelotinib tablets were administered orally once daily	Total n=432 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	90 Participants n=5 Participants	95 Participants n=7 Participants	185 Participants n=5 Participants
Age, Categorical >=65 years	125 Participants n=5 Participants	122 Participants n=7 Participants	247 Participants n=5 Participants
Age, Continuous	67 years n=5 Participants	66 years n=7 Participants	66 years n=5 Participants
Sex: Female, Male Female	91 Participants n=5 Participants	97 Participants n=7 Participants	188 Participants n=5 Participants
Sex: Female, Male Male	124 Participants n=5 Participants	120 Participants n=7 Participants	244 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	191 Participants n=5 Participants	194 Participants n=7 Participants	385 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Race/Ethnicity, Customized White	179 Participants n=5 Participants	178 Participants n=7 Participants	357 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	17 Participants n=5 Participants	20 Participants n=7 Participants	37 Participants n=5 Participants
Race/Ethnicity, Customized Not Permitted	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Transfusion Dependent Yes	53 Participants n=5 Participants	52 Participants n=7 Participants	105 Participants n=5 Participants
Transfusion Dependent No	162 Participants n=5 Participants	165 Participants n=7 Participants	327 Participants n=5 Participants
Platelet Count (10^9/L) < 100	18 Participants n=5 Participants	23 Participants n=7 Participants	41 Participants n=5 Participants
Platelet Count (10^9/L) >= 100 and <= 200	66 Participants n=5 Participants	63 Participants n=7 Participants	129 Participants n=5 Participants
Platelet Count (10^9/L) > 200	131 Participants n=5 Participants	131 Participants n=7 Participants	262 Participants n=5 Participants
Weight	69.3 kg n=5 Participants	71.4 kg n=7 Participants	70.0 kg n=5 Participants
Height	170.0 cm n=5 Participants	170.0 cm n=7 Participants	170.0 cm n=5 Participants
BMI	24.6 kg/m^2 n=5 Participants	24.9 kg/m^2 n=7 Participants	24.6 kg/m^2 n=5 Participants
Hemoglobin	10.5 g/dL n=5 Participants	10.3 g/dL n=7 Participants	10.4 g/dL n=5 Participants

PRIMARY outcome

Timeframe: Week 24

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.

Outcome measures

Outcome measures
Measure	Momelotinib (MMB) n=215 Participants 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.	Ruxolitinib (RUX) n=217 Participants 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.
Splenic Response Rate at Week 24 Responder	57 Participants	64 Participants
Splenic Response Rate at Week 24 Nonresponder	158 Participants	153 Participants

SECONDARY outcome

Timeframe: Week 24

Population: 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.

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

Outcome measures

Outcome measures
Measure	Momelotinib (MMB) n=211 Participants 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.	Ruxolitinib (RUX) n=211 Participants 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.
Total Symptom Score (TSS) Response Rate at Week 24 Responder	60 Participants	89 Participants
Total Symptom Score (TSS) Response Rate at Week 24 Nonresponder	151 Participants	122 Participants

SECONDARY outcome

Timeframe: Baseline to Week 24

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.

Outcome measures

Outcome measures
Measure	Momelotinib (MMB) n=215 Participants 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.	Ruxolitinib (RUX) n=217 Participants 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.
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)	0.0 units/month Interval 0.0 to 0.2	0.4 units/month Interval 0.0 to 1.5

SECONDARY outcome

Timeframe: Week 24

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.

Outcome measures

Outcome measures
Measure	Momelotinib (MMB) n=215 Participants 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.	Ruxolitinib (RUX) n=217 Participants 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.
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) Responder	143 Participants	107 Participants
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) Nonresponder	72 Participants	110 Participants

SECONDARY outcome

Timeframe: Week 24

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.

Outcome measures

Outcome measures
Measure	Momelotinib (MMB) n=215 Participants 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.	Ruxolitinib (RUX) n=217 Participants 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.
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)). Dependent	65 Participants	87 Participants
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)). Nondependent	150 Participants	130 Participants

Adverse Events

Momelotinib (MMB)

Serious events: 49 serious events

Other events: 197 other events

Deaths: 8 deaths

Ruxolitinib (RUX)

Serious events: 39 serious events

Other events: 206 other events

Deaths: 6 deaths

MMB to MMB

Serious events: 79 serious events

Other events: 153 other events

Deaths: 44 deaths

RUX to MMB

Serious events: 79 serious events

Other events: 188 other events

Deaths: 54 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

Sierra Oncology, a GlaxoSmithKline company

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Agreements varied with individual investigators, but did not prohibit any investigator from publishing. Investigators were not to publish results of the study until a period of time (eg. 2 years) following completion of the trial at all participating institutions but could do so earlier with consent of the Sponsor.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Momelotinib (MMB) n=214 participants at risk 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.	Ruxolitinib (RUX) n=216 participants at risk 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.	MMB to MMB n=171 participants at risk After completion of the 24-week double-blind treatment phase, participants had the option to receive MMB in an open-label treatment phase for up to an additional 216 weeks. Participants randomized to the MMB group at study entry continued MMB in the open-label treatment phase at their current dose. Available MMB strengths were 100 mg, 150 mg and 200 mg.	RUX to MMB n=197 participants at risk After completion of the 24-week double-blind treatment phase, participants had the option to receive MMB in an open-label treatment phase for up to an additional 216 weeks. Participants randomized to the RUX group who wished to remain in the study initiated MMB in the open-label treatment phase at the dose matching their equivalent MMB placebo dose. Available MMB strengths were 100 mg, 150 mg and 200 mg.
Blood and lymphatic system disorders Anaemia	1.9% 4/214 • 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. 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.	3.7% 8/216 • 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. 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.	4.1% 7/171 • 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. 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.	2.0% 4/197 • 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. 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.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/214 • 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. 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.	0.00% 0/216 • 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. 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.	1.2% 2/171 • 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. 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.	0.00% 0/197 • 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. 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.
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.58% 1/171 • 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. 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.	0.00% 0/197 • 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. 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.
Blood and lymphatic system disorders Leukopenia	0.00% 0/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.00% 0/171 • 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. 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.	0.51% 1/197 • 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. 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.
Blood and lymphatic system disorders Microangiopathic haemolytic anaemia	0.47% 1/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.00% 0/171 • 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. 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.	0.00% 0/197 • 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. 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.
Blood and lymphatic system disorders Neutropenia	0.00% 0/214 • 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. 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.	0.46% 1/216 • 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. 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.	0.00% 0/171 • 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. 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.	0.51% 1/197 • 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. 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.
Blood and lymphatic system disorders Splenic haematoma	0.00% 0/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.00% 0/171 • 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. 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.	1.0% 2/197 • 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. 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.
Blood and lymphatic system disorders Splenic infarction	0.47% 1/214 • 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. 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.	0.00% 0/216 • 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. 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.	1.8% 3/171 • 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. 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.	0.00% 0/197 • 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. 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.
Blood and lymphatic system disorders Splenic thrombosis	0.00% 0/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.58% 1/171 • 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. 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.	0.00% 0/197 • 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. 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.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/214 • 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. 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.	1.4% 3/216 • 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. 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.	0.00% 0/171 • 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. 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.	2.0% 4/197 • 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. 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.
Blood and lymphatic system disorders Thrombocytosis	0.47% 1/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.00% 0/171 • 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. 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.	0.00% 0/197 • 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. 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.
Cardiac disorders Acute myocardial infarction	0.93% 2/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.58% 1/171 • 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. 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.	0.51% 1/197 • 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. 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.
Cardiac disorders Angina unstable	0.47% 1/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.58% 1/171 • 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. 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.	0.00% 0/197 • 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. 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.
Cardiac disorders Atrial fibrillation	1.9% 4/214 • 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. 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.	0.46% 1/216 • 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. 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.	1.8% 3/171 • 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. 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.	2.0% 4/197 • 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. 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.
Cardiac disorders Atrial flutter	0.00% 0/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.00% 0/171 • 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. 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.	0.51% 1/197 • 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. 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.
Cardiac disorders Atrioventricular block	0.00% 0/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.58% 1/171 • 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. 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.	0.00% 0/197 • 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. 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.
Cardiac disorders Atrioventricular block complete	0.47% 1/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.00% 0/171 • 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. 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.	0.00% 0/197 • 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. 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.
Cardiac disorders Bradycardia	0.00% 0/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.00% 0/171 • 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. 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.	0.51% 1/197 • 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. 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.
Cardiac disorders Cardiac arrest	0.00% 0/214 • 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. 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.	0.00% 0/216 • 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. 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.	1.2% 2/171 • 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. 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.	0.51% 1/197 • 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. 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.
Cardiac disorders Cardiac failure	0.93% 2/214 • 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. 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.	0.00% 0/216 • 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. 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.	2.9% 5/171 • 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. 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.	1.0% 2/197 • 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. 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.
Cardiac disorders Cardiac failure acute	0.00% 0/214 • 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. 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.	0.93% 2/216 • 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. 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.	0.00% 0/171 • 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. 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.	0.00% 0/197 • 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. 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.
Cardiac disorders Cardiac failure chronic	0.00% 0/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.00% 0/171 • 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. 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.	0.51% 1/197 • 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. 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.
Cardiac disorders Cardiac failure congestive	0.47% 1/214 • 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. 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.	0.46% 1/216 • 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. 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.	1.2% 2/171 • 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. 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.	0.51% 1/197 • 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. 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.
Cardiac disorders Cardiomyopathy	0.00% 0/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.58% 1/171 • 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. 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.	0.00% 0/197 • 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. 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.
Cardiac disorders Coronary artery disease	0.00% 0/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.58% 1/171 • 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. 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.	0.00% 0/197 • 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. 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.
Cardiac disorders Hypertensive heart disease	0.00% 0/214 • 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. 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.	0.46% 1/216 • 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. 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.	0.00% 0/171 • 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. 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.	0.00% 0/197 • 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. 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.
Cardiac disorders Left ventricular failure	0.00% 0/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.58% 1/171 • 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. 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.	0.00% 0/197 • 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. 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.
Cardiac disorders Myocardial infarction	0.00% 0/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.58% 1/171 • 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. 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.	0.51% 1/197 • 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. 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.
Cardiac disorders Pericardial effusion	0.47% 1/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.00% 0/171 • 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. 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.	0.00% 0/197 • 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. 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.
Cardiac disorders Sinus bradycardia	0.00% 0/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.58% 1/171 • 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. 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.	0.00% 0/197 • 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. 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.
Cardiac disorders Tachycardia	0.00% 0/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.58% 1/171 • 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. 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.	0.00% 0/197 • 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. 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.
Ear and labyrinth disorders Vertigo	0.00% 0/214 • 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. 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.	0.93% 2/216 • 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. 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.	0.00% 0/171 • 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. 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.	0.51% 1/197 • 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. 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.
Eye disorders Cataract	0.00% 0/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.00% 0/171 • 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. 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.	0.51% 1/197 • 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. 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.
Eye disorders Cataract nuclear	0.00% 0/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.58% 1/171 • 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. 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.	0.00% 0/197 • 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. 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.
Eye disorders Eye haemorrhage	0.00% 0/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.58% 1/171 • 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. 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.	0.00% 0/197 • 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. 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.
Eye disorders Eye pain	0.00% 0/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.58% 1/171 • 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. 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.	0.00% 0/197 • 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. 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.
Eye disorders Vision blurred	0.00% 0/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.58% 1/171 • 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. 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.	0.00% 0/197 • 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. 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.
Gastrointestinal disorders Abdominal pain	0.47% 1/214 • 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. 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.	0.46% 1/216 • 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. 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.	0.00% 0/171 • 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. 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.	1.0% 2/197 • 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. 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.
Gastrointestinal disorders Ascites	0.00% 0/214 • 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. 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.	0.46% 1/216 • 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. 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.	0.58% 1/171 • 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. 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.	0.00% 0/197 • 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. 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.
Gastrointestinal disorders Colitis	0.00% 0/214 • 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. 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.	0.00% 0/216 • 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. 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.	0.58% 1/171 • 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. 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.	0.00% 0/197 • 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. 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.

Other adverse events
Measure	Momelotinib (MMB) n=214 participants at risk 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.	Ruxolitinib (RUX) n=216 participants at risk 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.	MMB to MMB n=171 participants at risk After completion of the 24-week double-blind treatment phase, participants had the option to receive MMB in an open-label treatment phase for up to an additional 216 weeks. Participants randomized to the MMB group at study entry continued MMB in the open-label treatment phase at their current dose. Available MMB strengths were 100 mg, 150 mg and 200 mg.	RUX to MMB n=197 participants at risk After completion of the 24-week double-blind treatment phase, participants had the option to receive MMB in an open-label treatment phase for up to an additional 216 weeks. Participants randomized to the RUX group who wished to remain in the study initiated MMB in the open-label treatment phase at the dose matching their equivalent MMB placebo dose. Available MMB strengths were 100 mg, 150 mg and 200 mg.
Gastrointestinal disorders Abdominal pain	9.8% 21/214 • 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. 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.	11.1% 24/216 • 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. 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.	7.6% 13/171 • 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. 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.	13.2% 26/197 • 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. 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.
Investigations Alanine aminotransferase increased	4.7% 10/214 • 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. 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.	4.6% 10/216 • 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. 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.	2.9% 5/171 • 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. 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.	5.6% 11/197 • 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. 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.
Blood and lymphatic system disorders Anaemia	14.0% 30/214 • 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. 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.	36.6% 79/216 • 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. 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.	22.2% 38/171 • 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. 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.	14.7% 29/197 • 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. 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.
Musculoskeletal and connective tissue disorders Arthralgia	7.0% 15/214 • 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. 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.	4.6% 10/216 • 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. 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.	5.8% 10/171 • 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. 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.	6.6% 13/197 • 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. 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.
General disorders Asthenia	5.6% 12/214 • 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. 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.	7.4% 16/216 • 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. 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.	7.6% 13/171 • 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. 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.	6.1% 12/197 • 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. 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.
Musculoskeletal and connective tissue disorders Back pain	4.7% 10/214 • 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. 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.	4.6% 10/216 • 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. 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.	5.8% 10/171 • 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. 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.	9.6% 19/197 • 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. 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.
Investigations Blood creatinine increased	4.2% 9/214 • 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. 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.	0.93% 2/216 • 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. 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.	5.8% 10/171 • 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. 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.	5.1% 10/197 • 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. 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.
Musculoskeletal and connective tissue disorders Bone pain	1.4% 3/214 • 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. 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.	6.9% 15/216 • 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. 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.	2.3% 4/171 • 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. 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.	6.1% 12/197 • 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. 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.
Gastrointestinal disorders Constipation	9.8% 21/214 • 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. 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.	6.9% 15/216 • 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. 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.	7.6% 13/171 • 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. 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.	9.1% 18/197 • 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. 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.
Injury, poisoning and procedural complications Contusion	7.5% 16/214 • 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. 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.	4.6% 10/216 • 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. 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.	5.3% 9/171 • 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. 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.	2.5% 5/197 • 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. 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.
Respiratory, thoracic and mediastinal disorders Cough	8.4% 18/214 • 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. 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.	7.9% 17/216 • 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. 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.	13.5% 23/171 • 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. 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.	17.3% 34/197 • 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. 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.
Metabolism and nutrition disorders Decreased appetite	5.1% 11/214 • 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. 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.	6.0% 13/216 • 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. 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.	8.8% 15/171 • 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. 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.	7.6% 15/197 • 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. 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.
Gastrointestinal disorders Diarrhoea	16.8% 36/214 • 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. 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.	19.4% 42/216 • 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. 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.	17.5% 30/171 • 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. 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.	18.8% 37/197 • 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. 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.
Nervous system disorders Dizziness	15.9% 34/214 • 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. 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.	11.6% 25/216 • 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. 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.	9.9% 17/171 • 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. 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.	12.7% 25/197 • 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. 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.9% 19/214 • 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. 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.	7.9% 17/216 • 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. 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.	8.2% 14/171 • 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. 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.	8.1% 16/197 • 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. 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.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.2% 9/214 • 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. 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.	6.5% 14/216 • 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. 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.	4.7% 8/171 • 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. 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.	6.1% 12/197 • 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. 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.
General disorders Fatigue	14.5% 31/214 • 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. 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.	12.0% 26/216 • 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. 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.	9.9% 17/171 • 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. 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.	19.3% 38/197 • 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. 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.
Vascular disorders Flushing	6.1% 13/214 • 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. 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.	0.46% 1/216 • 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. 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.	0.58% 1/171 • 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. 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.	1.5% 3/197 • 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. 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.
Nervous system disorders Headache	17.8% 38/214 • 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. 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.	19.9% 43/216 • 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. 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.	7.6% 13/171 • 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. 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.	12.2% 24/197 • 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. 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.
Vascular disorders Hypertension	4.2% 9/214 • 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. 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.	8.8% 19/216 • 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. 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.	5.8% 10/171 • 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. 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.	9.1% 18/197 • 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. 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.
Metabolism and nutrition disorders Hyperuricaemia	4.7% 10/214 • 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. 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.	3.2% 7/216 • 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. 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.	6.4% 11/171 • 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. 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.	7.1% 14/197 • 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. 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.
Vascular disorders Hypotension	8.4% 18/214 • 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. 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.	0.46% 1/216 • 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. 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.	3.5% 6/171 • 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. 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.	4.6% 9/197 • 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. 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.
Musculoskeletal and connective tissue disorders Muscle spasms	3.7% 8/214 • 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. 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.	5.1% 11/216 • 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. 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.	0.58% 1/171 • 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. 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.	2.5% 5/197 • 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. 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.
Infections and infestations Nasopharyngitis	4.2% 9/214 • 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. 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.	7.4% 16/216 • 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. 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.	4.1% 7/171 • 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. 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.	7.1% 14/197 • 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. 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.
Gastrointestinal disorders Nausea	15.4% 33/214 • 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. 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.	3.7% 8/216 • 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. 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.	9.4% 16/171 • 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. 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.	19.8% 39/197 • 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. 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.
Blood and lymphatic system disorders Neutropenia	4.2% 9/214 • 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. 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.	6.5% 14/216 • 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. 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.	4.1% 7/171 • 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. 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.	3.6% 7/197 • 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. 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.
General disorders Oedema peripheral	4.7% 10/214 • 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. 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.	6.0% 13/216 • 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. 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.	9.4% 16/171 • 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. 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.	5.1% 10/197 • 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. 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.
Musculoskeletal and connective tissue disorders Pain in extremity	6.5% 14/214 • 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. 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.	8.3% 18/216 • 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. 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.	6.4% 11/171 • 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. 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.	9.6% 19/197 • 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. 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.
Nervous system disorders Paraesthesia	7.0% 15/214 • 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. 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.	3.2% 7/216 • 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. 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.	3.5% 6/171 • 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. 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.	5.6% 11/197 • 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. 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.
Nervous system disorders Peripheral sensory neuropathy	9.3% 20/214 • 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. 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.	5.6% 12/216 • 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. 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.	8.8% 15/171 • 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. 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.	14.2% 28/197 • 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. 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.
Skin and subcutaneous tissue disorders Pruritus	4.7% 10/214 • 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. 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.	5.1% 11/216 • 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. 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.	7.0% 12/171 • 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. 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.	10.2% 20/197 • 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. 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.
General disorders Pyrexia	5.6% 12/214 • 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. 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.	6.5% 14/216 • 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. 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.	8.8% 15/171 • 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. 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.	7.1% 14/197 • 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. 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.
Skin and subcutaneous tissue disorders Rash	4.2% 9/214 • 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. 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.	2.3% 5/216 • 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. 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.	5.8% 10/171 • 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. 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.	6.1% 12/197 • 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. 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.
Blood and lymphatic system disorders Thrombocytopenia	18.7% 40/214 • 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. 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.	28.7% 62/216 • 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. 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.	17.0% 29/171 • 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. 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.	19.8% 39/197 • 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. 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.
Infections and infestations Upper respiratory tract infection	5.6% 12/214 • 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. 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.	6.5% 14/216 • 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. 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.	10.5% 18/171 • 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. 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.	9.1% 18/197 • 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. 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.
Infections and infestations Urinary tract infection	4.7% 10/214 • 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. 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.	4.2% 9/216 • 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. 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.	11.1% 19/171 • 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. 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.	9.6% 19/197 • 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. 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.
Gastrointestinal disorders Vomiting	9.3% 20/214 • 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. 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.	3.2% 7/216 • 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. 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.	4.7% 8/171 • 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. 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.	5.6% 11/197 • 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. 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.
Skin and subcutaneous tissue disorders Night sweats	3.7% 8/214 • 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. 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.	4.2% 9/216 • 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. 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.	7.0% 12/171 • 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. 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.	8.6% 17/197 • 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. 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.
Metabolism and nutrition disorders Vitamin B1 deficiency	3.3% 7/214 • 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. 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.	5.6% 12/216 • 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. 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.	4.7% 8/171 • 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. 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.	5.6% 11/197 • 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. 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.
Injury, poisoning and procedural complications Fall	2.8% 6/214 • 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. 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.	1.9% 4/216 • 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. 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.	5.3% 9/171 • 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. 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.	4.1% 8/197 • 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. 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.