Trial Outcomes & Findings for Ofatumumab for Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT NCT01113632)

Last Updated: 2016-09-20

Results Overview

The Number of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

77 participants

Primary outcome timeframe

18 months

Results posted on

2016-09-20

Participant Flow

Participant milestones

Participant milestones
Measure	Ofatumumab 1000mg Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.	Ofatumumab 2000mg Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.
Overall Study STARTED	33	44
Overall Study COMPLETED	2	19
Overall Study NOT COMPLETED	31	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ofatumumab for Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ofatumumab 1000mg n=33 Participants Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.	Ofatumumab 2000mg n=44 Participants Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.	Total n=77 Participants Total of all reporting groups
Age, Continuous	75 years n=5 Participants	69 years n=7 Participants	72 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	25 Participants n=7 Participants	41 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	44 participants n=7 Participants	77 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Population: All patients who were evaluable for a response assessment

Outcome measures

Outcome measures
Measure	Ofatumumab 1000mg n=28 Participants Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg.	Ofatumumab 2000mg n=44 Participants Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.
Overall Response Rate (ORR)	15 participants	30 participants

SECONDARY outcome

Timeframe: 18 months

To assess the overall response rate of patients with previously untreated CLL or SLL receiving ofatumumab.

Outcome measures

Outcome measures
Measure	Ofatumumab 1000mg n=33 Participants Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg.	Ofatumumab 2000mg n=44 Participants Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.
Progression-free Survival (PFS)	19.8 months Interval 9.7 to Upper bound of the 95% confidence interval cannot be calculated as there is an insufficient number of events for this caluclation	32.5 months Interval 26.6 to Upper bound of the 95% confidence interval cannot be calculated as there is an insufficient number of events for this caluclation

SECONDARY outcome

Timeframe: 18 Months

Population: All patients who were evaluable for a response assessment

The Number of Patients Who Experience a Complete Response From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions

Outcome measures

Outcome measures
Measure	Ofatumumab 1000mg n=28 Participants Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg.	Ofatumumab 2000mg n=44 Participants Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.
Number of Complete Responses	2 participants	0 participants

SECONDARY outcome

Timeframe: 18 Months

Population: All patients who were evaluable for a response assessment

The Number of Patients Who Experience a Partial Response From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions

Outcome measures

Outcome measures
Measure	Ofatumumab 1000mg n=28 Participants Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg.	Ofatumumab 2000mg n=44 Participants Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.
Number of Partial Responses	13 participants	30 participants

SECONDARY outcome

Timeframe: 18 Months

Listing of all non-serious Adverse Events ocurring in 5% of patients or more

Outcome measures

Outcome measures
Measure	Ofatumumab 1000mg n=33 Participants Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg.	Ofatumumab 2000mg n=44 Participants Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.
Safety of the Treatment Regimen Platelet count decreased	13 participants	10 participants
Safety of the Treatment Regimen Rash	7 participants	16 participants
Safety of the Treatment Regimen White blood cell decreased	10 participants	9 participants
Safety of the Treatment Regimen Cough	5 participants	13 participants
Safety of the Treatment Regimen Diarrhea	8 participants	9 participants
Safety of the Treatment Regimen Neutrophil count decreased	7 participants	10 participants
Safety of the Treatment Regimen Dyspnea	6 participants	9 participants
Safety of the Treatment Regimen Peripheral sensory neuropathy	2 participants	11 participants
Safety of the Treatment Regimen Constipation	2 participants	10 participants
Safety of the Treatment Regimen Insomnia	3 participants	9 participants
Safety of the Treatment Regimen Psychiatric disorders - Other, unspecified	5 participants	7 participants
Safety of the Treatment Regimen Arthralgia	4 participants	7 participants
Safety of the Treatment Regimen Pruritus	4 participants	3 participants
Safety of the Treatment Regimen Abdominal pain	2 participants	4 participants
Safety of the Treatment Regimen Allergic rhinitis	3 participants	3 participants
Safety of the Treatment Regimen Anorexia	2 participants	4 participants
Safety of the Treatment Regimen Back pain	2 participants	4 participants
Safety of the Treatment Regimen Fever	2 participants	4 participants
Safety of the Treatment Regimen Skin and subcutaneous tissue disorders - Other	4 participants	1 participants
Safety of the Treatment Regimen Alanine aminotransferase increased	2 participants	2 participants
Safety of the Treatment Regimen Blurred vision	4 participants	0 participants
Safety of the Treatment Regimen Bruising	1 participants	3 participants
Safety of the Treatment Regimen Chills	1 participants	3 participants
Safety of the Treatment Regimen Creatinine increased	1 participants	3 participants
Safety of the Treatment Regimen Hypokalemia	1 participants	3 participants
Safety of the Treatment Regimen Infusion related reaction	1 participants	3 participants
Safety of the Treatment Regimen Urinary frequency	1 participants	3 participants
Safety of the Treatment Regimen Weight loss	2 participants	2 participants
Safety of the Treatment Regimen Fatigue	12 participants	21 participants
Safety of the Treatment Regimen Allergic reaction	14 participants	16 participants
Safety of the Treatment Regimen Anemia	14 participants	13 participants
Safety of the Treatment Regimen Pain	9 participants	14 participants
Safety of the Treatment Regimen Hyperglycemia	4 participants	11 participants
Safety of the Treatment Regimen Edema	8 participants	6 participants
Safety of the Treatment Regimen Nausea	3 participants	11 participants
Safety of the Treatment Regimen Infections and infestations - Other, unspecified	6 participants	7 participants
Safety of the Treatment Regimen Dizziness	5 participants	5 participants
Safety of the Treatment Regimen Hyperhidrosis	6 participants	4 participants
Safety of the Treatment Regimen Hypocalcemia	4 participants	5 participants
Safety of the Treatment Regimen Aspartate aminotransferase increased	6 participants	2 participants
Safety of the Treatment Regimen Blood bilirubin increased	2 participants	6 participants
Safety of the Treatment Regimen Oral pain	1 participants	7 participants
Safety of the Treatment Regimen Respiratory, thoracic and mediastinal disorders	3 participants	5 participants
Safety of the Treatment Regimen Non-cardiac chest pain	1 participants	6 participants
Safety of the Treatment Regimen Gastrointestinal disorders - Other, unknown	3 participants	3 participants
Safety of the Treatment Regimen Headache	4 participants	2 participants
Safety of the Treatment Regimen Hypertension	3 participants	3 participants
Safety of the Treatment Regimen Hyponatremia	4 participants	2 participants
Safety of the Treatment Regimen Dysgeusia	2 participants	3 participants
Safety of the Treatment Regimen Flushing	1 participants	4 participants
Safety of the Treatment Regimen Gastroesophageal reflux disease	3 participants	2 participants
Safety of the Treatment Regimen Hypoglycemia	2 participants	3 participants
Safety of the Treatment Regimen Musculoskeletal and connective tissue disorders	2 participants	3 participants
Safety of the Treatment Regimen Upper respiratory infection	0 participants	5 participants
Safety of the Treatment Regimen Vomiting	1 participants	4 participants

Adverse Events

Ofatumumab 1000mg

Serious events: 3 serious events

Other events: 32 other events

Deaths: 0 deaths

Ofatumumab 2000mg

Serious events: 2 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ofatumumab 1000mg n=33 participants at risk Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.	Ofatumumab 2000mg n=44 participants at risk Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	3.0% 1/33 • 18 Months	0.00% 0/44 • 18 Months
Blood and lymphatic system disorders Anemia	3.0% 1/33 • 18 Months	0.00% 0/44 • 18 Months
Investigations Cholesterol high	3.0% 1/33 • 18 Months	0.00% 0/44 • 18 Months
Investigations Creatinine increased	0.00% 0/33 • 18 Months	2.3% 1/44 • 18 Months
Nervous system disorders Dysgeusia	3.0% 1/33 • 18 Months	0.00% 0/44 • 18 Months
General disorders Edema	3.0% 1/33 • 18 Months	0.00% 0/44 • 18 Months
General disorders Fever	3.0% 1/33 • 18 Months	0.00% 0/44 • 18 Months
Gastrointestinal disorders Gastrointestinal disorders - Other, hernia	3.0% 1/33 • 18 Months	0.00% 0/44 • 18 Months
Gastrointestinal disorders Gastrointestinal disorders - Other, unknown	3.0% 1/33 • 18 Months	0.00% 0/44 • 18 Months
Metabolism and nutrition disorders Hypoalbuminemia	3.0% 1/33 • 18 Months	0.00% 0/44 • 18 Months
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/33 • 18 Months	2.3% 1/44 • 18 Months
Skin and subcutaneous tissue disorders Urticaria	3.0% 1/33 • 18 Months	0.00% 0/44 • 18 Months
Gastrointestinal disorders Vomiting	3.0% 1/33 • 18 Months	0.00% 0/44 • 18 Months

Other adverse events

Other adverse events
Measure	Ofatumumab 1000mg n=33 participants at risk Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.	Ofatumumab 2000mg n=44 participants at risk Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.
General disorders Fatigue	36.4% 12/33 • 18 Months	47.7% 21/44 • 18 Months
Immune system disorders Allergic reaction	42.4% 14/33 • 18 Months	36.4% 16/44 • 18 Months
Blood and lymphatic system disorders Anemia	42.4% 14/33 • 18 Months	29.5% 13/44 • 18 Months
General disorders Pain	27.3% 9/33 • 18 Months	31.8% 14/44 • 18 Months
Investigations Platelet count decreased	39.4% 13/33 • 18 Months	22.7% 10/44 • 18 Months
Skin and subcutaneous tissue disorders Rash	21.2% 7/33 • 18 Months	36.4% 16/44 • 18 Months
Investigations White blood cell decreased	30.3% 10/33 • 18 Months	20.5% 9/44 • 18 Months
Respiratory, thoracic and mediastinal disorders Cough	15.2% 5/33 • 18 Months	29.5% 13/44 • 18 Months
Gastrointestinal disorders Diarrhea	24.2% 8/33 • 18 Months	20.5% 9/44 • 18 Months
Investigations Neutrophil count decreased	21.2% 7/33 • 18 Months	22.7% 10/44 • 18 Months
Respiratory, thoracic and mediastinal disorders Dyspnea	18.2% 6/33 • 18 Months	20.5% 9/44 • 18 Months
Metabolism and nutrition disorders Hyperglycemia	12.1% 4/33 • 18 Months	25.0% 11/44 • 18 Months
General disorders Edema	24.2% 8/33 • 18 Months	13.6% 6/44 • 18 Months
Gastrointestinal disorders Nausea	9.1% 3/33 • 18 Months	25.0% 11/44 • 18 Months
Infections and infestations Infections and infestations - Other, unspecified	18.2% 6/33 • 18 Months	15.9% 7/44 • 18 Months
Nervous system disorders Peripheral sensory neuropathy	6.1% 2/33 • 18 Months	25.0% 11/44 • 18 Months
Gastrointestinal disorders Constipation	6.1% 2/33 • 18 Months	22.7% 10/44 • 18 Months
Psychiatric disorders Insomnia	9.1% 3/33 • 18 Months	20.5% 9/44 • 18 Months
Psychiatric disorders Psychiatric disorders - Other, mood alteration	15.2% 5/33 • 18 Months	15.9% 7/44 • 18 Months
Musculoskeletal and connective tissue disorders Arthralgia	12.1% 4/33 • 18 Months	15.9% 7/44 • 18 Months
Nervous system disorders Dizziness	15.2% 5/33 • 18 Months	11.4% 5/44 • 18 Months
Skin and subcutaneous tissue disorders Hyperhidrosis	18.2% 6/33 • 18 Months	9.1% 4/44 • 18 Months
Metabolism and nutrition disorders Hypocalcemia	12.1% 4/33 • 18 Months	11.4% 5/44 • 18 Months
Investigations Aspartate aminotransferase increased	18.2% 6/33 • 18 Months	4.5% 2/44 • 18 Months
Investigations Blood bilirubin increased	6.1% 2/33 • 18 Months	13.6% 6/44 • 18 Months
Gastrointestinal disorders Oral pain	3.0% 1/33 • 18 Months	15.9% 7/44 • 18 Months
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, unknown	9.1% 3/33 • 18 Months	11.4% 5/44 • 18 Months
General disorders Non-cardiac chest pain	3.0% 1/33 • 18 Months	13.6% 6/44 • 18 Months
Skin and subcutaneous tissue disorders Pruritus	12.1% 4/33 • 18 Months	6.8% 3/44 • 18 Months
Gastrointestinal disorders Abdominal pain	6.1% 2/33 • 18 Months	9.1% 4/44 • 18 Months
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	9.1% 3/33 • 18 Months	6.8% 3/44 • 18 Months
Metabolism and nutrition disorders Anorexia	6.1% 2/33 • 18 Months	9.1% 4/44 • 18 Months
Musculoskeletal and connective tissue disorders Back pain	6.1% 2/33 • 18 Months	9.1% 4/44 • 18 Months
General disorders Fever	6.1% 2/33 • 18 Months	9.1% 4/44 • 18 Months
Gastrointestinal disorders Gastrointestinal disorders - Other, unknown	9.1% 3/33 • 18 Months	6.8% 3/44 • 18 Months
Nervous system disorders Headache	12.1% 4/33 • 18 Months	4.5% 2/44 • 18 Months
Vascular disorders Hypertension	9.1% 3/33 • 18 Months	6.8% 3/44 • 18 Months
Metabolism and nutrition disorders Hyponatremia	12.1% 4/33 • 18 Months	4.5% 2/44 • 18 Months
Nervous system disorders Dysgeusia	6.1% 2/33 • 18 Months	6.8% 3/44 • 18 Months
Vascular disorders Flushing	3.0% 1/33 • 18 Months	9.1% 4/44 • 18 Months
Gastrointestinal disorders Gastroesophageal reflux disease	9.1% 3/33 • 18 Months	4.5% 2/44 • 18 Months
Metabolism and nutrition disorders Hypoglycemia	6.1% 2/33 • 18 Months	6.8% 3/44 • 18 Months
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders - Other, unknown	6.1% 2/33 • 18 Months	6.8% 3/44 • 18 Months
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	12.1% 4/33 • 18 Months	2.3% 1/44 • 18 Months
Infections and infestations Upper respiratory infection	0.00% 0/33 • 18 Months	11.4% 5/44 • 18 Months
Gastrointestinal disorders Vomiting	3.0% 1/33 • 18 Months	9.1% 4/44 • 18 Months
Investigations Alanine aminotransferase increased	6.1% 2/33 • 18 Months	4.5% 2/44 • 18 Months
Eye disorders Blurred vision	12.1% 4/33 • 18 Months	0.00% 0/44 • 18 Months
Injury, poisoning and procedural complications Bruising	3.0% 1/33 • 18 Months	6.8% 3/44 • 18 Months
General disorders Chills	3.0% 1/33 • 18 Months	6.8% 3/44 • 18 Months
Investigations Creatinine increased	3.0% 1/33 • 18 Months	6.8% 3/44 • 18 Months
Metabolism and nutrition disorders Hypokalemia	3.0% 1/33 • 18 Months	6.8% 3/44 • 18 Months
General disorders Infusion related reaction	3.0% 1/33 • 18 Months	6.8% 3/44 • 18 Months
Renal and urinary disorders Urinary frequency	3.0% 1/33 • 18 Months	6.8% 3/44 • 18 Months
Investigations Weight loss	6.1% 2/33 • 18 Months	4.5% 2/44 • 18 Months

Additional Information

John D Hainsworth, MD

Sarah Cannon Research Institute

Phone: 1-877-691-7274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
Publication restrictions are in place

Restriction type: OTHER