Trial Outcomes & Findings for Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated Indolent B-Cell Non-Hodgkin Lymphoma (NCT NCT05169658)

NCT ID: NCT05169658

Last Updated: 2026-05-13

Results Overview

A simple binary proportion will be used to estimate CR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

42 participants

Primary outcome timeframe

At the end of treatment completion, an average of 5.5 months after starting treatment.

Results posted on

2026-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Mosunetuzumab) PART A: Patients receive mosunetuzumab SC over 30 seconds - 2 minutes on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET/CT, PET/CT and CT scans, bone marrow biopsy, bone marrow aspirate, and collection of blood samples throughout the study. PART B: Observation only as complete response achieved from Part A. Mosunetuzumab: Given SC FDG-Positron Emission Tomography: Undergo FDG-PET and FDG-PET/CT Computed Tomography: Undergo CT and FDG-PET/CT Positron Emission Tomography: Undergo PET/CT and FDG-PET/CT Bone Marrow Biopsy: Undergo bone marrow biopsy Bone Marrow Aspiration: Undergo bone marrow aspiration Biospecimen Collection: Undergo blood sample collection	Treatment (Mosunetuzumab, Obinutuzumab, and Polatuzumab) PART A: Patients receive mosunetuzumab SC over 30 seconds - 2 minutes on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET/CT, PET/CT and CT scans, bone marrow biopsy, bone marrow aspirate, and collection of blood samples throughout the study. PART B: Beginning cycle 9, patients who do not achieve a CR receive obinutuzumab IV on day 1, 8, and 15 of cycle 9 and day 1 of subsequent cycles and polatuzumab vedotin IV on day 1. Treatment repeats every 21 day for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT, and FDG-PET scans, bone marrow biopsy, bone marrow aspirate, and collection of blood samples throughout the study. Mosunetuzumab: Given SC FDG-Positron Emission Tomography: Undergo FDG-PET and FDG-PET/CT Computed Tomography: Undergo CT and FDG-PET/CT Positron Emission Tomography: Undergo PET/CT and FDG-PET/CT Bone Marrow Biopsy: Undergo bone marrow biopsy Bone Marrow Aspiration: Undergo bone marrow aspiration Biospecimen Collection: Undergo blood sample collection
Overall Study STARTED	31	11
Overall Study COMPLETED	30	6
Overall Study NOT COMPLETED	1	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Mosunetuzumab) PART A: Patients receive mosunetuzumab SC over 30 seconds - 2 minutes on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET/CT, PET/CT and CT scans, bone marrow biopsy, bone marrow aspirate, and collection of blood samples throughout the study. PART B: Observation only as complete response achieved from Part A. Mosunetuzumab: Given SC FDG-Positron Emission Tomography: Undergo FDG-PET and FDG-PET/CT Computed Tomography: Undergo CT and FDG-PET/CT Positron Emission Tomography: Undergo PET/CT and FDG-PET/CT Bone Marrow Biopsy: Undergo bone marrow biopsy Bone Marrow Aspiration: Undergo bone marrow aspiration Biospecimen Collection: Undergo blood sample collection	Treatment (Mosunetuzumab, Obinutuzumab, and Polatuzumab) PART A: Patients receive mosunetuzumab SC over 30 seconds - 2 minutes on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET/CT, PET/CT and CT scans, bone marrow biopsy, bone marrow aspirate, and collection of blood samples throughout the study. PART B: Beginning cycle 9, patients who do not achieve a CR receive obinutuzumab IV on day 1, 8, and 15 of cycle 9 and day 1 of subsequent cycles and polatuzumab vedotin IV on day 1. Treatment repeats every 21 day for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT, and FDG-PET scans, bone marrow biopsy, bone marrow aspirate, and collection of blood samples throughout the study. Mosunetuzumab: Given SC FDG-Positron Emission Tomography: Undergo FDG-PET and FDG-PET/CT Computed Tomography: Undergo CT and FDG-PET/CT Positron Emission Tomography: Undergo PET/CT and FDG-PET/CT Bone Marrow Biopsy: Undergo bone marrow biopsy Bone Marrow Aspiration: Undergo bone marrow aspiration Biospecimen Collection: Undergo blood sample collection
Overall Study Adverse Event	1	1
Overall Study Withdrawal by Subject	0	1
Overall Study Lack of Efficacy	0	1
Overall Study Physician Decision	0	2

Baseline Characteristics

Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated Indolent B-Cell Non-Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Mosunetuzumab, Obinutuzumab, Polatuzumab Vedotin) n=42 Participants PART A: Patients receive mosunetuzumab SC over 30 seconds - 2 minutes on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET/CT, PET/CT and CT scans, bone marrow biopsy, bone marrow aspirate, and collection of blood samples throughout the study. PART B: Beginning cycle 9, patients who do not achieve a CR receive obinutuzumab IV on day 1, 8, and 15 of cycle 9 and day 1 of subsequent cycles and polatuzumab vedotin IV on day 1. Treatment repeats every 21 day for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT, and FDG-PET scans, bone marrow biopsy, bone marrow aspirate, and collection of blood samples throughout the study. Mosunetuzumab: Given SC Obinutuzumab: Given IV Polatuzumab Vedotin: Given IV FDG-Positron Emission Tomography: Undergo FDG-PET and FDG-PET/CT Computed Tomography: Undergo CT and FDG-PET/CT Positron Emission Tomography: Undergo PET/CT and FDG-PET/CT Bone Marrow Biopsy: Undergo bone marrow biopsy Bone Marrow Aspiration: Undergo bone marrow aspiration Biospecimen Collection: Undergo blood sample collection
Age, Categorical <=18 years	0 Participants n=1512 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=1512 Participants
Age, Categorical >=65 years	15 Participants n=1512 Participants
Age, Continuous	58.45 years n=1512 Participants
Sex: Female, Male Female	20 Participants n=1512 Participants
Sex: Female, Male Male	22 Participants n=1512 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=1512 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=1512 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=1512 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=1512 Participants
Race (NIH/OMB) Asian	5 Participants n=1512 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1512 Participants
Race (NIH/OMB) Black or African American	1 Participants n=1512 Participants
Race (NIH/OMB) White	30 Participants n=1512 Participants
Race (NIH/OMB) More than one race	1 Participants n=1512 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=1512 Participants
Region of Enrollment United States	42 participants n=1512 Participants

PRIMARY outcome

Timeframe: At the end of treatment completion, an average of 5.5 months after starting treatment.

Population: Complete response was intended to be assessed and reported as a single combined group for this study, with stratification of complete response by treatment part an exploratory endpoint.

A simple binary proportion will be used to estimate CR.

Outcome measures

Outcome measures
Measure	Treatment (Mosunetuzumab, Obinutuzumab, Polatuzumab Vedotin) n=42 Participants PART A: Patients receive mosunetuzumab SC over 30 seconds - 2 minutes on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET/CT, PET/CT and CT scans, bone marrow biopsy, bone marrow aspirate, and collection of blood samples throughout the study. PART B: Beginning cycle 9, patients who do not achieve a CR receive obinutuzumab IV on day 1, 8, and 15 of cycle 9 and day 1 of subsequent cycles and polatuzumab vedotin IV on day 1. Treatment repeats every 21 day for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT, and FDG-PET scans, bone marrow biopsy, bone marrow aspirate, and collection of blood samples throughout the study. Mosunetuzumab: Given SC Obinutuzumab: Given IV Polatuzumab Vedotin: Given IV FDG-Positron Emission Tomography: Undergo FDG-PET and FDG-PET/CT Computed Tomography: Undergo CT and FDG-PET/CT Positron Emission Tomography: Undergo PET/CT and FDG-PET/CT Bone Marrow Biopsy: Undergo bone marrow biopsy Bone Marrow Aspiration: Undergo bone marrow aspiration Biospecimen Collection: Undergo blood sample collection
Complete Response (CR)	38 Participants

SECONDARY outcome

Timeframe: At the end of treatment completion, an average of 5.5 months after starting treatment.

Population: Overall response rate was intended to be assessed and reported as a single combined group for this study, with stratification of overall response rate by treatment part an exploratory endpoint.

A simple binary proportion will be used to estimate ORR.

Outcome measures

Outcome measures
Measure	Treatment (Mosunetuzumab, Obinutuzumab, Polatuzumab Vedotin) n=42 Participants PART A: Patients receive mosunetuzumab SC over 30 seconds - 2 minutes on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET/CT, PET/CT and CT scans, bone marrow biopsy, bone marrow aspirate, and collection of blood samples throughout the study. PART B: Beginning cycle 9, patients who do not achieve a CR receive obinutuzumab IV on day 1, 8, and 15 of cycle 9 and day 1 of subsequent cycles and polatuzumab vedotin IV on day 1. Treatment repeats every 21 day for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT, and FDG-PET scans, bone marrow biopsy, bone marrow aspirate, and collection of blood samples throughout the study. Mosunetuzumab: Given SC Obinutuzumab: Given IV Polatuzumab Vedotin: Given IV FDG-Positron Emission Tomography: Undergo FDG-PET and FDG-PET/CT Computed Tomography: Undergo CT and FDG-PET/CT Positron Emission Tomography: Undergo PET/CT and FDG-PET/CT Bone Marrow Biopsy: Undergo bone marrow biopsy Bone Marrow Aspiration: Undergo bone marrow aspiration Biospecimen Collection: Undergo blood sample collection
Overall Response Rate (ORR)	42 Participants

Adverse Events

Treatment (Mosunetuzumab, Obinutuzumab, Polatuzumab Vedotin)

Serious events: 5 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Mosunetuzumab, Obinutuzumab, Polatuzumab Vedotin) n=42 participants at risk PART A: Patients receive mosunetuzumab SC over 30 seconds - 2 minutes on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET/CT, PET/CT and CT scans, bone marrow biopsy, bone marrow aspirate, and collection of blood samples throughout the study. PART B: Beginning cycle 9, patients who do not achieve a CR receive obinutuzumab IV on day 1, 8, and 15 of cycle 9 and day 1 of subsequent cycles and polatuzumab vedotin IV on day 1. Treatment repeats every 21 day for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT, and FDG-PET scans, bone marrow biopsy, bone marrow aspirate, and collection of blood samples throughout the study. Mosunetuzumab: Given SC Obinutuzumab: Given IV Polatuzumab Vedotin: Given IV FDG-Positron Emission Tomography: Undergo FDG-PET and FDG-PET/CT Computed Tomography: Undergo CT and FDG-PET/CT Positron Emission Tomography: Undergo PET/CT and FDG-PET/CT Bone Marrow Biopsy: Undergo bone marrow biopsy Bone Marrow Aspiration: Undergo bone marrow aspiration Biospecimen Collection: Undergo blood sample collection
Infections and infestations Lung infection	2.4% 1/42 • Number of events 1 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Infections and infestations Shingles	2.4% 1/42 • Number of events 1 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Immune system disorders Cytokine release syndrome	2.4% 1/42 • Number of events 1 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
General disorders Fever	2.4% 1/42 • Number of events 1 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Cardiac disorders Tachycardia	2.4% 1/42 • Number of events 1 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Abdominal pain	2.4% 1/42 • Number of events 1 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Malabsorption	2.4% 1/42 • Number of events 1 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Infections and infestations Upper respiratory infection	2.4% 1/42 • Number of events 1 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Blood and lymphatic system disorders Febrile neutropenia	2.4% 1/42 • Number of events 1 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.

Other adverse events

Other adverse events
Measure	Treatment (Mosunetuzumab, Obinutuzumab, Polatuzumab Vedotin) n=42 participants at risk PART A: Patients receive mosunetuzumab SC over 30 seconds - 2 minutes on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET/CT, PET/CT and CT scans, bone marrow biopsy, bone marrow aspirate, and collection of blood samples throughout the study. PART B: Beginning cycle 9, patients who do not achieve a CR receive obinutuzumab IV on day 1, 8, and 15 of cycle 9 and day 1 of subsequent cycles and polatuzumab vedotin IV on day 1. Treatment repeats every 21 day for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT, and FDG-PET scans, bone marrow biopsy, bone marrow aspirate, and collection of blood samples throughout the study. Mosunetuzumab: Given SC Obinutuzumab: Given IV Polatuzumab Vedotin: Given IV FDG-Positron Emission Tomography: Undergo FDG-PET and FDG-PET/CT Computed Tomography: Undergo CT and FDG-PET/CT Positron Emission Tomography: Undergo PET/CT and FDG-PET/CT Bone Marrow Biopsy: Undergo bone marrow biopsy Bone Marrow Aspiration: Undergo bone marrow aspiration Biospecimen Collection: Undergo blood sample collection
Nervous system disorders Dysgeusia	7.1% 3/42 • Number of events 3 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Nervous system disorders Dizziness	11.9% 5/42 • Number of events 7 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Skin and subcutaneous tissue disorders Dry skin	42.9% 18/42 • Number of events 20 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Investigations Alanine aminotransferase increased	35.7% 15/42 • Number of events 24 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Investigations Alkaline phosphatase increased	7.1% 3/42 • Number of events 5 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Investigations Aspartate aminotransferase increased	19.0% 8/42 • Number of events 12 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Musculoskeletal and connective tissue disorders Back pain	19.0% 8/42 • Number of events 8 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Bloating	11.9% 5/42 • Number of events 5 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Investigations Blood lactate dehydrogenase increased	7.1% 3/42 • Number of events 3 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Musculoskeletal and connective tissue disorders Bone pain	7.1% 3/42 • Number of events 4 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Injury, poisoning and procedural complications Bruising	11.9% 5/42 • Number of events 8 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Skin and subcutaneous tissue disorders Cellulitis	7.1% 3/42 • Number of events 3 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
General disorders Chills	38.1% 16/42 • Number of events 22 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Respiratory, thoracic and mediastinal disorders Congestion	19.0% 8/42 • Number of events 9 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Constipation	26.2% 11/42 • Number of events 11 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 14/42 • Number of events 18 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Infections and infestations COVID-19	9.5% 4/42 • Number of events 4 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Immune system disorders Cytokine release syndrom	42.9% 18/42 • Number of events 27 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Metabolism and nutrition disorders Anorexia	9.5% 4/42 • Number of events 4 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Diarrhea	28.6% 12/42 • Number of events 21 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Respiratory, thoracic and mediastinal disorders Dyspnea	14.3% 6/42 • Number of events 6 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
General disorders Edema	9.5% 4/42 • Number of events 4 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
General disorders Edema limbs	11.9% 5/42 • Number of events 7 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
General disorders Fatigue	64.3% 27/42 • Number of events 31 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
General disorders Fever	47.6% 20/42 • Number of events 38 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
General disorders Flu like symptoms	9.5% 4/42 • Number of events 4 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Skin and subcutaneous tissue disorders Alopecia	7.1% 3/42 • Number of events 3 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Nervous system disorders Headache	59.5% 25/42 • Number of events 37 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Infections and infestations Herpes labialis	9.5% 4/42 • Number of events 4 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Respiratory, thoracic and mediastinal disorders Hiccups	7.1% 3/42 • Number of events 3 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Metabolism and nutrition disorders Hyperglycemia	35.7% 15/42 • Number of events 18 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Vascular disorders Hypertension	11.9% 5/42 • Number of events 6 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Metabolism and nutrition disorders Hypocalcemia	26.2% 11/42 • Number of events 16 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Metabolism and nutrition disorders Hypokalemia	11.9% 5/42 • Number of events 6 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Metabolism and nutrition disorders Hyponatremia	9.5% 4/42 • Number of events 5 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Metabolism and nutrition disorders Hypophosphatemia	7.1% 3/42 • Number of events 3 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Infections and infestations Rhinovirus	7.1% 3/42 • Number of events 3 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
General disorders Injection site reaction	88.1% 37/42 • Number of events 44 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Psychiatric disorders Insomnia	47.6% 20/42 • Number of events 23 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Skin and subcutaneous tissue disorders Pruritus	35.7% 15/42 • Number of events 16 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Musculoskeletal and connective tissue disorders Muscle cramp	7.1% 3/42 • Number of events 3 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Musculoskeletal and connective tissue disorders Myalgia	21.4% 9/42 • Number of events 12 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Nausea	26.2% 11/42 • Number of events 11 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Nervous system disorders Peripheral sensory neuropathy	11.9% 5/42 • Number of events 5 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Investigations Neutrophil count decreased	21.4% 9/42 • Number of events 20 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Skin and subcutaneous tissue disorders Hyperhidrosis	11.9% 5/42 • Number of events 5 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Abdominal pain	7.1% 3/42 • Number of events 3 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
General disorders Pain	7.1% 3/42 • Number of events 3 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Investigations Platelet count decreased	26.2% 11/42 • Number of events 18 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Respiratory, thoracic and mediastinal disorders Postnasal drip	7.1% 3/42 • Number of events 3 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Skin and subcutaneous tissue disorders Rash	21.4% 9/42 • Number of events 18 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Skin and subcutaneous tissue disorders Rash acneiform	7.1% 3/42 • Number of events 3 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Skin and subcutaneous tissue disorders Rash maculo-papular	21.4% 9/42 • Number of events 10 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Infections and infestations Shingles	7.1% 3/42 • Number of events 3 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Infections and infestations Sinusitis	7.1% 3/42 • Number of events 3 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Skin and subcutaneous tissue disorders Skin sensitivity	7.1% 3/42 • Number of events 4 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Cardiac disorders Tachycardia	9.5% 4/42 • Number of events 5 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Nervous system disorders Tingling	9.5% 4/42 • Number of events 5 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Infections and infestations Upper respiratory infection	19.0% 8/42 • Number of events 8 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.
Gastrointestinal disorders Vomiting	9.5% 4/42 • Number of events 5 • Up until off study visit (Up to 11 months and 6 days) Adverse event data collection was intended to be assessed and reported as a single combined group for this study.

Additional Information

Dr. Ryan Lynch

University of Washington

Phone: 206-606-1739

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place