Trial Outcomes & Findings for Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia (NCT NCT02124746)

Last Updated: 2023-06-18

Results Overview

Long-term safety and tolerability profile of momelotinib based on safety data (adverse events and selected hematology and chemistry laboratory parameters) collected after the first dose of momelotinib in the parent study.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

87 participants

Primary outcome timeframe

From the first dose of momelotinib in the parent study to 30 days following permanent discontinuation of momelotinib in Study GS-US-352-1154.

Results posted on

2023-06-18

Participant Flow

Benefiting subjects enrolled in 1 of 3 prior momelotinib (MMB) studies (parent studies) for the treatment of MF were included for continued dosing of MMB. Cohort 3 (PV/ET; n=13) was closed and subjects were discontinued due to limited efficacy of MMB in the treatment of PV/ET observed in the parent study. Cohort 3 was excluded from all analyses.

Participant milestones

Participant milestones
Measure	Cohort 1 (CCL09101/ CCL09101E/ GS-US-352-1154) Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study CCL09101/ CCL09101E.	Cohort 2 (YM387-II-02/GS-US-352-1154) Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study YM387-II-02.	Cohort 4 (GS-US-352-1672/GS-US-352-1154) Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study GS-US-352-1672.
Overall Study STARTED	30	22	22
Overall Study COMPLETED	11	4	0
Overall Study NOT COMPLETED	19	18	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 (CCL09101/ CCL09101E/ GS-US-352-1154) Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study CCL09101/ CCL09101E.	Cohort 2 (YM387-II-02/GS-US-352-1154) Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study YM387-II-02.	Cohort 4 (GS-US-352-1672/GS-US-352-1154) Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study GS-US-352-1672.
Overall Study Adverse Event	2	1	2
Overall Study Death	2	1	3
Overall Study Lack of Efficacy	3	2	2
Overall Study Physician Decision	6	4	5
Overall Study Non-Compliance with Study Drug	0	1	0
Overall Study Withdrawal by Subject	3	3	0
Overall Study Study Terminated by Sponsor	0	0	6
Overall Study Disease Progression	3	6	4

Baseline Characteristics

Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 (CCL09101/ CCL09101E/ GS-US-352-1154) n=30 Participants Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study CCL09101/ CCL09101E.	Cohort 2 (YM387-II-02/GS-US-352-1154) n=22 Participants Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study YM387-II-02.	Cohort 4 (GS-US-352-1672/GS-US-352-1154) n=22 Participants Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study GS-US-352-1672.	Total n=74 Participants Total of all reporting groups
Age, Continuous	66.0 years n=5 Participants	64.0 years n=7 Participants	68.0 years n=5 Participants	66.5 years n=4 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	36 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants	38 Participants n=4 Participants
Race/Ethnicity, Customized White	26 Participants n=5 Participants	20 Participants n=7 Participants	18 Participants n=5 Participants	64 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Transfusion Dependent (at baseline in parent study) Yes	7 Participants n=5 Participants	7 Participants n=7 Participants	22 Participants n=5 Participants	36 Participants n=4 Participants
Transfusion Dependent (at baseline in parent study) No	23 Participants n=5 Participants	12 Participants n=7 Participants	0 Participants n=5 Participants	35 Participants n=4 Participants
Transfusion Dependent (at baseline in parent study) Missing	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants

PRIMARY outcome

Timeframe: From the first dose of momelotinib in the parent study to 30 days following permanent discontinuation of momelotinib in Study GS-US-352-1154.

Population: It was pre-specified that safety outcomes would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore data for this outcome measure are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.

Outcome measures

Outcome measures
Measure	Total n=74 Participants All subjects enrolled to Study GS-US-352-1154	Cohort 2 (YM387-II-02/GS-US-352-1154) Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study YM387-II-02.	Cohort 4 (GS-US-352-1672/GS-US-352-1154) Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study GS-US-352-1672.	Total All subjects enrolled to Study GS-US-352-1154
Long Term Safety and Tolerability as Measured by the Incidence and Severity of Adverse Events and Clinical Laboratory Abnormalities Subjects with ≥ one AE (any grade)	73 Participants	—	—	—
Long Term Safety and Tolerability as Measured by the Incidence and Severity of Adverse Events and Clinical Laboratory Abnormalities Subjects with ≥ one Grade 3 or higher AE	62 Participants	—	—	—
Long Term Safety and Tolerability as Measured by the Incidence and Severity of Adverse Events and Clinical Laboratory Abnormalities Subjects with Grade 3 lab toxicity (highest grade)	36 Participants	—	—	—
Long Term Safety and Tolerability as Measured by the Incidence and Severity of Adverse Events and Clinical Laboratory Abnormalities Subjects with Grade 4 lab toxicity (highest grade)	16 Participants	—	—	—

SECONDARY outcome

Timeframe: From baseline in the parent study until the last spleen assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.

Population: Subjects with splenomegaly \>5 cm at baseline in the parent studies who were enrolled in Study GS-US-352-1154 were evaluable for splenic response assessment.

The number of subjects achieving a spleen response, defined as a reduction of 50% or more in palpable splenomegaly of a spleen that was at least 10 cm below the LCM at baseline, or a spleen that was palpable at \> 5 cm and \< 10 cm below the LCM at baseline becoming not palpable for at least 56 days, using baseline of the parent study as the reference.

Outcome measures

Outcome measures
Measure	Total n=25 Participants All subjects enrolled to Study GS-US-352-1154	Cohort 2 (YM387-II-02/GS-US-352-1154) n=21 Participants Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study YM387-II-02.	Cohort 4 (GS-US-352-1672/GS-US-352-1154) n=17 Participants Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study GS-US-352-1672.	Total n=63 Participants All subjects enrolled to Study GS-US-352-1154
Splenic Response Rate	20 Participants	19 Participants	6 Participants	45 Participants

SECONDARY outcome

Timeframe: From baseline in the parent study until the last spleen assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.

Population: Duration of splenic response was assessed for spleen responders who enrolled in Study GS-US-352-1154 only.

The interval from the first onset of splenic response (in the parent study or Study GS-US-352-1154) to the earliest date of loss of splenic response. Loss of response was defined as the reduction of splenomegaly by \< 50% among responders (with splenomegaly ≥ 10 cm below the LCM at baseline) that lasts ≥ 56 days, or the recurrence of \> 0 cm splenomegaly among responders (with splenomegaly \> 5 and \< 10 cm at baseline) that lasts ≥ 56 days. Duration of splenic response was measured by descriptive statistics. Data from responders who maintained their response was censored at the last assessment date.

Outcome measures

Outcome measures
Measure	Total n=20 Participants All subjects enrolled to Study GS-US-352-1154	Cohort 2 (YM387-II-02/GS-US-352-1154) n=19 Participants Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study YM387-II-02.	Cohort 4 (GS-US-352-1672/GS-US-352-1154) n=6 Participants Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study GS-US-352-1672.	Total n=45 Participants All subjects enrolled to Study GS-US-352-1154
Duration of Splenic Response	1704.5 days Interval 1153.5 to 2682.0	736.0 days Interval 197.0 to 1070.0	447.5 days Interval 128.0 to 758.0	990.0 days Interval 226.0 to 1802.0

SECONDARY outcome

Timeframe: From baseline in the parent study until the last assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.

Population: Subjects who were transfusion dependent at baseline in the parent studies and were enrolled in Study GS-US-352-1154 were evaluable for transfusion independence response.

The number of transfusion dependent subjects at entry to a parent study who became transfusion-independent for ≥ 12 weeks at any time from the first dose of momelotinib in the parent study until the end of Study GS-US-352-1154.

Outcome measures

Outcome measures
Measure	Total n=7 Participants All subjects enrolled to Study GS-US-352-1154	Cohort 2 (YM387-II-02/GS-US-352-1154) n=7 Participants Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study YM387-II-02.	Cohort 4 (GS-US-352-1672/GS-US-352-1154) n=22 Participants Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study GS-US-352-1672.	Total n=36 Participants All subjects enrolled to Study GS-US-352-1154
Transfusion Independence Response Rate	7 Participants	5 Participants	16 Participants	28 Participants

SECONDARY outcome

Timeframe: From baseline in the parent study until the last assessment date in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.

Population: Duration of transfusion independence response was assessed for transfusion independence responders who were enrolled in Study GS-US-352-1154.

The interval from the first onset date of transfusion independence (in the parent study or Study GS-US-352-1154) to the earliest date of loss of response for participants who are transfusion dependent at baseline in the parent study. Loss of TI response was defined as receiving an RBC transfusion after achieving a TI response. Duration of transfusion independence response was measured by descriptive statistics. Data from responders who maintained their response was censored at the last assessment date.

Outcome measures

Outcome measures
Measure	Total n=7 Participants All subjects enrolled to Study GS-US-352-1154	Cohort 2 (YM387-II-02/GS-US-352-1154) n=5 Participants Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study YM387-II-02.	Cohort 4 (GS-US-352-1672/GS-US-352-1154) n=16 Participants Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study GS-US-352-1672.	Total n=28 Participants All subjects enrolled to Study GS-US-352-1154
Duration of Transfusion Independence Response	357.0 days Interval 117.0 to 1841.0	114.0 days Interval 95.0 to 126.0	281.5 days Interval 110.0 to 633.5	193.5 days Interval 110.0 to 701.0

SECONDARY outcome

Timeframe: From baseline in the parent study until the last assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.

Population: Subjects who were anemia response-evaluable at baseline in the parent studies and were enrolled in Study GS-US-352-1154 were evaluable for anemia response.

The number of subjects achieving an anemia response, defined as: * Achieving transfusion independence for ≥ 12 weeks, for subjects who were transfusion-dependent at baseline in the parent study, or * Having ≥ 2 g/dL increase in Hgb from baseline for ≥ 12 weeks, for subjects with Hgb \< 10 g/dL at baseline in the parent study who were not transfusion-dependent (Cohort 1) or who were transfusion-independent (Cohort 2).

Outcome measures

Outcome measures
Measure	Total n=18 Participants All subjects enrolled to Study GS-US-352-1154	Cohort 2 (YM387-II-02/GS-US-352-1154) n=12 Participants Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study YM387-II-02.	Cohort 4 (GS-US-352-1672/GS-US-352-1154) n=22 Participants Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study GS-US-352-1672.	Total n=52 Participants All subjects enrolled to Study GS-US-352-1154
Anemia Response Rate	13 Participants	6 Participants	16 Participants	35 Participants

SECONDARY outcome

Timeframe: From baseline in the parent study until the last assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.

Population: Duration of anemia response was assessed for anemia responders who were enrolled in Study GS-US-352-1154.

The interval from the first onset of anemia response (in the parent study or Study GS-US-352-1154) to the earliest date of loss of anemia response. Loss of anemia response was defined as having any RBC transfusion after achieving an anemia response. Duration of anemia response was measured by descriptive statistics. Data from responders who maintained their response was censored at the last assessment date.

Outcome measures

Outcome measures
Measure	Total n=13 Participants All subjects enrolled to Study GS-US-352-1154	Cohort 2 (YM387-II-02/GS-US-352-1154) n=6 Participants Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study YM387-II-02.	Cohort 4 (GS-US-352-1672/GS-US-352-1154) n=16 Participants Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study GS-US-352-1672.	Total n=35 Participants All subjects enrolled to Study GS-US-352-1154
Duration of Anemia Response	995.0 days Interval 297.0 to 1841.0	120.0 days Interval 95.0 to 744.0	281.5 days Interval 110.0 to 633.5	358.0 days Interval 114.0 to 954.0

SECONDARY outcome

Timeframe: From the first dose of momelotinib in the parent study until the last dose of momelotinib in Study GS-US-352-1154.

The average number of RBC units per subject month during the parent study and/or Study GS-US-352-1154.

Outcome measures

Outcome measures
Measure	Total n=74 Participants All subjects enrolled to Study GS-US-352-1154	Cohort 2 (YM387-II-02/GS-US-352-1154) Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study YM387-II-02.	Cohort 4 (GS-US-352-1672/GS-US-352-1154) Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study GS-US-352-1672.	Total All subjects enrolled to Study GS-US-352-1154
Rate of RBC Transfusion RBC Transfusion Rate in Parent Studies	0.08 RBC units per month Interval 0.0 to 5.4	—	—	—
Rate of RBC Transfusion RBC Transfusion Rate in Study GS-US-352-1154	0.00 RBC units per month Interval 0.0 to 4.8	—	—	—
Rate of RBC Transfusion RBC Transfusion Rate Since 1st Dose in ParentStudy	0.06 RBC units per month Interval 0.0 to 4.9	—	—	—

SECONDARY outcome

Timeframe: From baseline in the parent study until the date of last contact or last response assessment, up to 30 days following permanent discontinuation of momelotinib.

The interval from the first dose of momelotinib in the parent study until death from any cause. Overall survival was analyzed using the Kaplan-Meier method. Data from subjects who were lost to follow-up or remained alive until the end of the study were censored at the date of last contact or last response assessment.

Outcome measures

Outcome measures
Measure	Total n=30 Participants All subjects enrolled to Study GS-US-352-1154	Cohort 2 (YM387-II-02/GS-US-352-1154) n=22 Participants Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study YM387-II-02.	Cohort 4 (GS-US-352-1672/GS-US-352-1154) n=22 Participants Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study GS-US-352-1672.	Total n=74 Participants All subjects enrolled to Study GS-US-352-1154
Overall Survival	NA months Interval 36.7 to 99.6 Median not reached, reporting full range of observed values	NA months Interval 28.1 to 81.6 Median not reached, reporting full range of observed values	NA months Interval 6.3 to 29.6 Median not reached, reporting full range of observed values	NA months Interval 6.3 to 99.6 Median not reached, reporting full range of observed values

SECONDARY outcome

Timeframe: From baseline in the parent study until the last response assessment, up to 30 days following permanent discontinuation of momelotinib.

The interval from the first dose of momelotinib in the parent study until the first documentation of definitive progressive disease as defined in 2006 IWG-MRT or death due to any cause. Subjects who were free of progression were censored at the last assessment date.

Outcome measures

Outcome measures
Measure	Total n=30 Participants All subjects enrolled to Study GS-US-352-1154	Cohort 2 (YM387-II-02/GS-US-352-1154) n=22 Participants Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study YM387-II-02.	Cohort 4 (GS-US-352-1672/GS-US-352-1154) n=22 Participants Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study GS-US-352-1672.	Total n=74 Participants All subjects enrolled to Study GS-US-352-1154
Progression-Free Survival	NA months Median could not be determined due to high level of censoring	NA months Median could not be determined due to high level of censoring	NA months Median could not be determined due to high level of censoring	NA months Median could not be determined due to high level of censoring

SECONDARY outcome

Timeframe: From baseline in the parent study until the date of the last assessment, up to 30 days following permanent discontinuation of momelotinib.

The interval from the first dose of momelotinib in the parent study until the first documented leukemic transformation or death from any cause. Leukemic transformation was documented in the adverse event electronic case report form. Leukemia-free survival was analyzed using the Kaplan-Meier method. Subjects who were free of leukemia transformation were censored at the last assessment date.

Outcome measures

Outcome measures
Measure	Total n=30 Participants All subjects enrolled to Study GS-US-352-1154	Cohort 2 (YM387-II-02/GS-US-352-1154) n=22 Participants Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study YM387-II-02.	Cohort 4 (GS-US-352-1672/GS-US-352-1154) n=22 Participants Subjects with PMF, post-PV MF or post-ET MF previously enrolled in parent study GS-US-352-1672.	Total n=74 Participants All subjects enrolled to Study GS-US-352-1154
Leukemia-Free Survival	NA months Interval 36.7 to 99.6 Median not reached, reporting full range of observed values	NA months Interval 28.1 to 81.6 Median not reached, reporting full range of observed values	NA months Interval 6.1 to 29.6 Median not reached, reporting full range of observed values	NA months Interval 6.1 to 99.6 Median not reached, reporting full range of observed values

Adverse Events

Total

Serious events: 49 serious events

Other events: 73 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Total n=74 participants at risk All subjects enrolled to Study GS-US-352-1154
Blood and lymphatic system disorders Anaemia	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Blood and lymphatic system disorders Febrile neutropenia	2.7% 2/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Blood and lymphatic system disorders Neutropenia	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Blood and lymphatic system disorders Thrombocytopenia	2.7% 2/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Cardiac disorders Angina pectoris	2.7% 2/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Cardiac disorders Aortic valve disease	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Cardiac disorders Atrial fibrillation	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Cardiac disorders Atrial flutter	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Cardiac disorders Atrioventricular block	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Cardiac disorders Cardiac failure	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Cardiac disorders Cardiac failure acute	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Cardiac disorders Cardiac failure congestive	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Cardiac disorders Cardiomyopathy	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Cardiac disorders Myocardial infarction	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Cardiac disorders Myocardial ischaemia	2.7% 2/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Cardiac disorders Palpitations	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Cardiac disorders Sinus node dysfunction	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Cardiac disorders Ventricular tachycardia	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Gastrointestinal disorders Abdominal pain	8.1% 6/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Gastrointestinal disorders Ascites	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Gastrointestinal disorders Colitis	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Gastrointestinal disorders Constipation	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Gastrointestinal disorders Diarrhoea	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Gastrointestinal disorders Haematochezia	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Gastrointestinal disorders Mouth haemorrhage	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Gastrointestinal disorders Salivary gland enlargement	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Gastrointestinal disorders Small intestinal obstruction	2.7% 2/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Gastrointestinal disorders Varices oesophageal	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
General disorders Asthenia	2.7% 2/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
General disorders Chest pain	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
General disorders Death	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
General disorders Pain	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
General disorders Pyrexia	2.7% 2/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Hepatobiliary disorders Cholecystitis chronic	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Appendicitis	2.7% 2/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Bacterial infection	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Bronchitis	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Cellulitis	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Clostridium difficile colitis	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Gastroenteritis	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Gastroenteritis escherichia coli	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Infection	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Localised infection	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Lung infection	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Peritonitis	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Pharyngitis	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Pneumococcal sepsis	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Pneumonia	9.5% 7/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Pneumonia klebsiella	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Pneumonia pneumococcal	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Pyelonephritis	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Respiratory syncytial virus infection	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Sepsis	4.1% 3/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Sinusitis bacterial	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Systemic mycosis	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Upper respiratory tract infection	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Urinary tract infection	4.1% 3/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Injury, poisoning and procedural complications Craniocerebral injury	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Injury, poisoning and procedural complications Fall	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Injury, poisoning and procedural complications Subdural haematoma	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Injury, poisoning and procedural complications Tendon injury	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Injury, poisoning and procedural complications Tibia fracture	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Investigations Blood creatinine increased	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Investigations Ejection fraction decreased	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Metabolism and nutrition disorders Dehydration	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Metabolism and nutrition disorders Hypokalaemia	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Metabolism and nutrition disorders Metabolic acidosis	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Musculoskeletal and connective tissue disorders Back pain	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Musculoskeletal and connective tissue disorders Bone pain	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Musculoskeletal and connective tissue disorders Muscular weakness	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Musculoskeletal and connective tissue disorders Myalgia	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mantle cell lymphoma	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-hodgkin's lymphoma	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Nervous system disorders Cerebral haemorrhage	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Nervous system disorders Dizziness	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Nervous system disorders Intracranial venous sinus thrombosis	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Nervous system disorders Ischaemic stroke	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Nervous system disorders Syncope	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Nervous system disorders Transient global amnesia	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Nervous system disorders Wernicke's encephalopathy	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Psychiatric disorders Delirium	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Renal and urinary disorders Acute kidney injury	6.8% 5/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Renal and urinary disorders Haematuria	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Renal and urinary disorders Nephrolithiasis	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Renal and urinary disorders Proteinuria	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.1% 3/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.1% 3/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Skin and subcutaneous tissue disorders Hyperhidrosis	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Vascular disorders Deep vein thrombosis	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Vascular disorders Hypotension	2.7% 2/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Vascular disorders Thrombosis	1.4% 1/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.

Other adverse events

Other adverse events
Measure	Total n=74 participants at risk All subjects enrolled to Study GS-US-352-1154
Blood and lymphatic system disorders Anaemia	36.5% 27/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Blood and lymphatic system disorders Leukocytosis	9.5% 7/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Blood and lymphatic system disorders Leukopenia	12.2% 9/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Blood and lymphatic system disorders Neutropenia	23.0% 17/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Blood and lymphatic system disorders Thrombocytopenia	37.8% 28/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Blood and lymphatic system disorders Thrombocytosis	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Cardiac disorders Atrial fibrillation	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Cardiac disorders Pericardial effusion	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Cardiac disorders Sinus bradycardia	9.5% 7/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Ear and labyrinth disorders Ear discomfort	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Eye disorders Cataract	12.2% 9/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Eye disorders Dry eye	10.8% 8/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Eye disorders Lacrimation increased	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Eye disorders Vision blurred	9.5% 7/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Gastrointestinal disorders Abdominal pain	31.1% 23/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Gastrointestinal disorders Abdominal pain upper	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Gastrointestinal disorders Constipation	25.7% 19/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Gastrointestinal disorders Diarrhoea	55.4% 41/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Gastrointestinal disorders Dyspepsia	10.8% 8/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Gastrointestinal disorders Gastrooesophageal reflux disease	6.8% 5/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Gastrointestinal disorders Nausea	44.6% 33/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Gastrointestinal disorders Vomiting	28.4% 21/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
General disorders Asthenia	6.8% 5/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
General disorders Chest pain	9.5% 7/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
General disorders Chills	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
General disorders Fatigue	47.3% 35/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
General disorders Influenza like illness	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
General disorders Oedema peripheral	25.7% 19/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
General disorders Pain	8.1% 6/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
General disorders Pyrexia	21.6% 16/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Bronchitis	9.5% 7/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Herpes zoster	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Influenza	10.8% 8/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Lung infection	8.1% 6/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Sinusitis	18.9% 14/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Upper respiratory tract infection	18.9% 14/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Infections and infestations Urinary tract infection	31.1% 23/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Injury, poisoning and procedural complications Contusion	29.7% 22/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Injury, poisoning and procedural complications Fall	10.8% 8/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Injury, poisoning and procedural complications Foot fracture	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Investigations Activated partial thromboplastin time prolonged	6.8% 5/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Investigations Alanine aminotransferase increased	25.7% 19/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Investigations Amylase increased	16.2% 12/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Investigations Aspartate aminotransferase increased	14.9% 11/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Investigations Blood alkaline phosphatase increased	6.8% 5/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Investigations Blood bilirubin increased	10.8% 8/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Investigations Blood creatinine increased	23.0% 17/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Investigations Blood uric acid increased	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Investigations Electrocardiogram QT prolonged	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Investigations Gamma-glutamyltransferase increased	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Investigations International normalised ratio increased	6.8% 5/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Investigations Lipase increased	20.3% 15/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Investigations Lymphocyte count decreased	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Investigations Neutrophil count decreased	6.8% 5/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Investigations Platelet count decreased	14.9% 11/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Investigations Weight decreased	10.8% 8/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Investigations Weight increased	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Investigations White blood cell count decreased	6.8% 5/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Metabolism and nutrition disorders Decreased appetite	13.5% 10/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Metabolism and nutrition disorders Dehydration	6.8% 5/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Metabolism and nutrition disorders Hyperglycaemia	10.8% 8/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Metabolism and nutrition disorders Hyperkalaemia	14.9% 11/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Metabolism and nutrition disorders Hyperuricaemia	24.3% 18/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Metabolism and nutrition disorders Hypocalcaemia	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Metabolism and nutrition disorders Hypokalaemia	8.1% 6/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Musculoskeletal and connective tissue disorders Arthralgia	28.4% 21/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Musculoskeletal and connective tissue disorders Back pain	16.2% 12/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Musculoskeletal and connective tissue disorders Bone pain	10.8% 8/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Musculoskeletal and connective tissue disorders Muscle spasms	6.8% 5/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Musculoskeletal and connective tissue disorders Muscular weakness	10.8% 8/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.8% 5/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Musculoskeletal and connective tissue disorders Myalgia	8.1% 6/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Musculoskeletal and connective tissue disorders Neck pain	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Musculoskeletal and connective tissue disorders Pain in extremity	24.3% 18/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Nervous system disorders Dizziness	37.8% 28/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Nervous system disorders Dysgeusia	6.8% 5/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Nervous system disorders Headache	37.8% 28/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Nervous system disorders Hypoaesthesia	6.8% 5/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Nervous system disorders Neuropathy peripheral	25.7% 19/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Nervous system disorders Paraesthesia	6.8% 5/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Nervous system disorders Peripheral sensory neuropathy	41.9% 31/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Nervous system disorders Syncope	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Psychiatric disorders Anxiety	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Psychiatric disorders Depression	9.5% 7/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Psychiatric disorders Insomnia	17.6% 13/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Renal and urinary disorders Acute kidney injury	6.8% 5/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Renal and urinary disorders Pollakiuria	8.1% 6/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Renal and urinary disorders Proteinuria	6.8% 5/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Renal and urinary disorders Urinary retention	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Respiratory, thoracic and mediastinal disorders Cough	28.4% 21/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Respiratory, thoracic and mediastinal disorders Dyspnoea	39.2% 29/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.8% 5/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	9.5% 7/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Respiratory, thoracic and mediastinal disorders Productive cough	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Respiratory, thoracic and mediastinal disorders Sinus congestion	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Skin and subcutaneous tissue disorders Alopecia	10.8% 8/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Skin and subcutaneous tissue disorders Night sweats	13.5% 10/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Skin and subcutaneous tissue disorders Petechiae	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Skin and subcutaneous tissue disorders Pruritus	13.5% 10/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Skin and subcutaneous tissue disorders Rash	16.2% 12/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Skin and subcutaneous tissue disorders Skin lesion	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Skin and subcutaneous tissue disorders Skin ulcer	5.4% 4/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Surgical and medical procedures Tooth extraction	6.8% 5/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Vascular disorders Flushing	10.8% 8/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Vascular disorders Haematoma	6.8% 5/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Vascular disorders Hypertension	18.9% 14/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.
Vascular disorders Hypotension	21.6% 16/74 • From the first dose of momelotinib in the parent study until 30 days after the last dose in Study GS-US-352-1154. Treatment-emergent AEs were defined as AEs with onset dates on or after the start of study drug in the parent study and no later than 30 days after permanent discontinuation of study drug, or any AEs leading to premature discontinuation of study drug. It was pre-specified that adverse event data would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore adverse event data are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Most restrictive: Site may not present or publish results of Trial without advance written notice of Sponsor or two years after completion of Trial at all participating sites. Site must submit all proposed publications or presentations to Sponsor for review. Sponsor can review communications prior to public release and embargo trial results communications for a period between 75 and 180 days from submission to Sponsor for review. Sponsor has right to request Site remove Confidential Information.
Publication restrictions are in place

Restriction type: OTHER