Trial Outcomes & Findings for A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLC (NCT NCT05144529)
NCT ID: NCT05144529
Last Updated: 2026-05-05
Results Overview
Safety is defined as the incidence of DLTs assessed in the first 6 evaluable subjects treated with nivolumab, ipilimumab, and evolocumab, including those that cross over to receive evolocumab.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Up to 30 days after first study dose
Results posted on
2026-05-05
Participant Flow
Participants were recruited from Duke University Health System and Duke Cancer Center Raleigh from March 2022 to August 2024.
Participant milestones
| Measure |
Ipilimumab/Nivolumab
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks.
Nivolumab: Nivolumab IV 240 mg
Ipilimumab: Ipilimumab IV 1 mg/kg
|
Ipilimumab/Nivolumab/Evolucumab
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks plus evolocumab 140 mg SC every 2 weeks
Nivolumab: Nivolumab IV 240 mg
Ipilimumab: Ipilimumab IV 1 mg/kg
Evolocumab: Evolocumab 14 mg subcutaneous injection
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
Reasons for withdrawal
| Measure |
Ipilimumab/Nivolumab
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks.
Nivolumab: Nivolumab IV 240 mg
Ipilimumab: Ipilimumab IV 1 mg/kg
|
Ipilimumab/Nivolumab/Evolucumab
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks plus evolocumab 140 mg SC every 2 weeks
Nivolumab: Nivolumab IV 240 mg
Ipilimumab: Ipilimumab IV 1 mg/kg
Evolocumab: Evolocumab 14 mg subcutaneous injection
|
|---|---|---|
|
Overall Study
Death
|
6
|
6
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Study Terminated Early
|
2
|
3
|
Baseline Characteristics
A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLC
Baseline characteristics by cohort
| Measure |
Ipilimumab/Nivolumab
n=9 Participants
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks.
Nivolumab: Nivolumab IV 240 mg
Ipilimumab: Ipilimumab IV 1 mg/kg
|
Ipilimumab/Nivolumab/Evolucumab
n=10 Participants
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks plus evolocumab 140 mg SC every 2 weeks
Nivolumab: Nivolumab IV 240 mg
Ipilimumab: Ipilimumab IV 1 mg/kg
Evolocumab: Evolocumab 14 mg subcutaneous injection
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.0 years
STANDARD_DEVIATION 7.7 • n=54 Participants
|
64.0 years
STANDARD_DEVIATION 8.8 • n=60 Participants
|
65.0 years
STANDARD_DEVIATION 8.1 • n=114 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
8 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
11 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=54 Participants
|
9 Participants
n=60 Participants
|
17 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
4 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
14 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after first study dosePopulation: The first 6 evaluable subjects treated with nivolumab, ipilimumab, and evolocumab, including those that cross over to receive evolocumab.
Safety is defined as the incidence of DLTs assessed in the first 6 evaluable subjects treated with nivolumab, ipilimumab, and evolocumab, including those that cross over to receive evolocumab.
Outcome measures
| Measure |
Ipilimumab/Nivolumab
n=2 Participants
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks.
Nivolumab: Nivolumab IV 240 mg
Ipilimumab: Ipilimumab IV 1 mg/kg
|
Ipilimumab/Nivolumab/Evolucumab
n=4 Participants
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks plus evolocumab 140 mg SC every 2 weeks
Nivolumab: Nivolumab IV 240 mg
Ipilimumab: Ipilimumab IV 1 mg/kg
Evolocumab: Evolocumab 14 mg subcutaneous injection
|
|---|---|---|
|
Number of Participants With DLT (Dose-limiting Toxicity)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and day 29Population: In the Ipilimumab/nivolumab arm, one participant did not have any tissue for analysis at Baseline; three did not have post treatment biopsies, and one had a biopsy but due to the poor quality of the section the CODEX machine was unable to recognize it. In the ipilimumab/nivolumab/evolucumab arm, one participant did not have a post treatment biopsy.
To characterize treatment-related changes in tumor infiltrating lymphocytes (TIL) using immunohistochemistry analysis. The mean and the standard deviation of the pre-treatment CD3+ TILs and the on-treatment CD3+ TILS as well as those of the difference of these ratios will be estimated.
Outcome measures
| Measure |
Ipilimumab/Nivolumab
n=8 Participants
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks.
Nivolumab: Nivolumab IV 240 mg
Ipilimumab: Ipilimumab IV 1 mg/kg
|
Ipilimumab/Nivolumab/Evolucumab
n=10 Participants
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks plus evolocumab 140 mg SC every 2 weeks
Nivolumab: Nivolumab IV 240 mg
Ipilimumab: Ipilimumab IV 1 mg/kg
Evolocumab: Evolocumab 14 mg subcutaneous injection
|
|---|---|---|
|
Change in CD3+ Tumor Infiltrating Lymphocytes
Baseline
|
7.132 % of total cells per participant
Standard Deviation 6.053
|
5.529 % of total cells per participant
Standard Deviation 2.81
|
|
Change in CD3+ Tumor Infiltrating Lymphocytes
Day 29
|
15.246 % of total cells per participant
Standard Deviation 27.088
|
19.1 % of total cells per participant
Standard Deviation 14.556
|
SECONDARY outcome
Timeframe: Baseline and day 29Population: Participants with sufficient amount of cells available in biopsy sample.
To assess the change in the degree of surface expression of MHC-I molecules on tumor cells within each patient comparing on-treatment versus pre-treatment biopsy specimens.
Outcome measures
| Measure |
Ipilimumab/Nivolumab
n=7 Participants
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks.
Nivolumab: Nivolumab IV 240 mg
Ipilimumab: Ipilimumab IV 1 mg/kg
|
Ipilimumab/Nivolumab/Evolucumab
n=6 Participants
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks plus evolocumab 140 mg SC every 2 weeks
Nivolumab: Nivolumab IV 240 mg
Ipilimumab: Ipilimumab IV 1 mg/kg
Evolocumab: Evolocumab 14 mg subcutaneous injection
|
|---|---|---|
|
Change in MHC-1 Expression
|
1.06 fold change
Standard Deviation 0.24
|
1.01 fold change
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: Up to 2 yearsPFS is defined as the time between initiation of treatment and initial failure (disease progression or death), whichever comes first.
Outcome measures
| Measure |
Ipilimumab/Nivolumab
n=9 Participants
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks.
Nivolumab: Nivolumab IV 240 mg
Ipilimumab: Ipilimumab IV 1 mg/kg
|
Ipilimumab/Nivolumab/Evolucumab
n=10 Participants
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks plus evolocumab 140 mg SC every 2 weeks
Nivolumab: Nivolumab IV 240 mg
Ipilimumab: Ipilimumab IV 1 mg/kg
Evolocumab: Evolocumab 14 mg subcutaneous injection
|
|---|---|---|
|
Progression-free Survival (PFS)
|
12 months
Interval 1.4 to
Not estimatable due to insufficient number of participants with events.
|
4.9 months
Interval 1.2 to 11.3
|
SECONDARY outcome
Timeframe: Up to 2 yearsOS is defined as the time from the first dose of study treatment to death.
Outcome measures
| Measure |
Ipilimumab/Nivolumab
n=9 Participants
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks.
Nivolumab: Nivolumab IV 240 mg
Ipilimumab: Ipilimumab IV 1 mg/kg
|
Ipilimumab/Nivolumab/Evolucumab
n=10 Participants
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks plus evolocumab 140 mg SC every 2 weeks
Nivolumab: Nivolumab IV 240 mg
Ipilimumab: Ipilimumab IV 1 mg/kg
Evolocumab: Evolocumab 14 mg subcutaneous injection
|
|---|---|---|
|
Overall Survival (OS)
|
27.3 months
Interval 7.6 to
Not estimatable due to insufficient number of participants with events.
|
12.7 months
Interval 1.3 to
Not estimatable due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 2 yearsResponse rate is defined as the percentage of treated subjects with a complete or partial response
Outcome measures
| Measure |
Ipilimumab/Nivolumab
n=9 Participants
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks.
Nivolumab: Nivolumab IV 240 mg
Ipilimumab: Ipilimumab IV 1 mg/kg
|
Ipilimumab/Nivolumab/Evolucumab
n=10 Participants
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks plus evolocumab 140 mg SC every 2 weeks
Nivolumab: Nivolumab IV 240 mg
Ipilimumab: Ipilimumab IV 1 mg/kg
Evolocumab: Evolocumab 14 mg subcutaneous injection
|
|---|---|---|
|
Objective Response Rate (ORR)
|
67 percentage of participants
Interval 36.0 to 97.0
|
50 percentage of participants
Interval 19.0 to 81.0
|
Adverse Events
Ipilimumab/Nivolumab
Serious events: 4 serious events
Other events: 9 other events
Deaths: 6 deaths
Ipilimumab/Nivolumab/Evolucumab
Serious events: 3 serious events
Other events: 10 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Ipilimumab/Nivolumab
n=9 participants at risk
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks.
Nivolumab: Nivolumab IV 240 mg
Ipilimumab: Ipilimumab IV 1 mg/kg
|
Ipilimumab/Nivolumab/Evolucumab
n=10 participants at risk
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks plus evolocumab 140 mg SC every 2 weeks
Nivolumab: Nivolumab IV 240 mg
Ipilimumab: Ipilimumab IV 1 mg/kg
Evolocumab: Evolocumab 14 mg subcutaneous injection
|
|---|---|---|
|
Blood and lymphatic system disorders
Acute deep vein thrombosis
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Infections and infestations
Septic shock
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Endocrine disorders
Adrenal insufficiency
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Gastrointestinal disorders
Colitis
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Gastrointestinal disorders
colitis/gastroenteritis
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea/vomiting
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Cardiac disorders
Pericardial effusion
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Cardiac disorders
Pericardial tamponade
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
Other adverse events
| Measure |
Ipilimumab/Nivolumab
n=9 participants at risk
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks.
Nivolumab: Nivolumab IV 240 mg
Ipilimumab: Ipilimumab IV 1 mg/kg
|
Ipilimumab/Nivolumab/Evolucumab
n=10 participants at risk
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks plus evolocumab 140 mg SC every 2 weeks
Nivolumab: Nivolumab IV 240 mg
Ipilimumab: Ipilimumab IV 1 mg/kg
Evolocumab: Evolocumab 14 mg subcutaneous injection
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
3/9 • Up to 2 years
|
40.0%
4/10 • Up to 2 years
|
|
Metabolism and nutrition disorders
Weight Gain 14.2% Increase From Baseline
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.1%
1/9 • Up to 2 years
|
20.0%
2/10 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Left Hip And Buttocks Radiating Down Leg.
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Left Hip Pain
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Left Shoulder And Upper Arm Pain
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Left Side Pain, Not Associated With Inhaling
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Soreness In Neck, Shoulders, Wrists, And Knees
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
11.1%
1/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
11.1%
1/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Nervous system disorders
Anosmia
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Nervous system disorders
Dizziness
|
22.2%
2/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Up to 2 years
|
20.0%
2/10 • Up to 2 years
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Nervous system disorders
Muscle Weakness Right-Sided
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Nervous system disorders
Paresthesia
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Nervous system disorders
Tremor
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Nervous system disorders
Numbness In Cheeks
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Nervous system disorders
Numbness In Legs
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Nervous system disorders
Spasms Of Pain In Right Temple
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Psychiatric disorders
Insomnia
|
22.2%
2/9 • Up to 2 years
|
20.0%
2/10 • Up to 2 years
|
|
Renal and urinary disorders
Proteinuria
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Renal and urinary disorders
Uti
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Renal and urinary disorders
Urinary Frequency
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Renal and urinary disorders
Urine Output Increased
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
2/9 • Up to 2 years
|
30.0%
3/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Covid
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
44.4%
4/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Lymphangitic Carcinomatosis
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Mild Upper Respiratory Symptoms, Sinus Congestion, Cough
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
11.1%
1/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
11.1%
1/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
11.1%
1/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.1%
1/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Immune Related Dermatitis
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
3/9 • Up to 2 years
|
50.0%
5/10 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
33.3%
3/9 • Up to 2 years
|
70.0%
7/10 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash Under Right Breast, Possible Fungal.
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin Lesion On Left Upper Abdomen
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Surgical and medical procedures
Prophylactic Treatment (Nailing) With Or Without Methylmethacrylate
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Surgical and medical procedures
Dental Surgery
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Investigations
Decreased Tsh
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Investigations
Increased Bun
|
11.1%
1/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Investigations
Lymphocyte Count Decreased
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Investigations
Neutrophil Count Decreased
|
22.2%
2/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Investigations
Platelet Count Decreased
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Investigations
Tsh Decreased
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Investigations
Thyroid Stimulating Hormone Increased
|
0.00%
0/9 • Up to 2 years
|
30.0%
3/10 • Up to 2 years
|
|
Investigations
Weight Gain
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
11.1%
1/9 • Up to 2 years
|
20.0%
2/10 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
3/9 • Up to 2 years
|
30.0%
3/10 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
6/9 • Up to 2 years
|
40.0%
4/10 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
22.2%
2/9 • Up to 2 years
|
20.0%
2/10 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.2%
2/9 • Up to 2 years
|
40.0%
4/10 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
22.2%
2/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Eye disorders
Eye Infection Hordeolum
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Eye disorders
Eye Infection, Hordeolum
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal Cramping
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
11.1%
1/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Gastrointestinal disorders
Bloating
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Up to 2 years
|
20.0%
2/10 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
3/9 • Up to 2 years
|
30.0%
3/10 • Up to 2 years
|
|
Gastrointestinal disorders
Dry Mouth
|
11.1%
1/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Gastrointestinal disorders
Hemorrhoidal Hemorrhage
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Gastrointestinal disorders
Lip Pain
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Gastrointestinal disorders
Mucositis Oral
|
33.3%
3/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
44.4%
4/9 • Up to 2 years
|
20.0%
2/10 • Up to 2 years
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Up to 2 years
|
20.0%
2/10 • Up to 2 years
|
|
Gastrointestinal disorders
Stomach Virus
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
General disorders
Chest Tightness
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
General disorders
Chills
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
General disorders
Fatigue
|
11.1%
1/9 • Up to 2 years
|
30.0%
3/10 • Up to 2 years
|
|
General disorders
Localized Edema
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
General disorders
Night Sweats
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
General disorders
Non-Cardiac Chest Pain
|
22.2%
2/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
General disorders
Pain
|
22.2%
2/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Hepatobiliary disorders
Immune Related Hepatitis
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Immune system disorders
Allergic Reaction
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Infections and infestations
Conjunctivitis Infective
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Infections and infestations
Enterocolitis Infectious
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Infections and infestations
Folliculitis
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Infections and infestations
Grade 1 Sinusitis Symptoms
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Infections and infestations
Papulopustular Rash
|
0.00%
0/9 • Up to 2 years
|
20.0%
2/10 • Up to 2 years
|
|
Infections and infestations
Sinusitis
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Infections and infestations
Skin Infection
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Infections and infestations
Thrush
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Infections and infestations
Upper Respiratory Infection
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Investigations
Alanine Aminotransferase Increased
|
33.3%
3/9 • Up to 2 years
|
30.0%
3/10 • Up to 2 years
|
|
Investigations
Alkaline Phosphatase Increased
|
44.4%
4/9 • Up to 2 years
|
30.0%
3/10 • Up to 2 years
|
|
Investigations
Aspartate Aminotransferase Increased
|
22.2%
2/9 • Up to 2 years
|
40.0%
4/10 • Up to 2 years
|
|
Investigations
Bun Increased
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Investigations
Creatinine Increased
|
0.00%
0/9 • Up to 2 years
|
30.0%
3/10 • Up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
22.2%
2/9 • Up to 2 years
|
50.0%
5/10 • Up to 2 years
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Cardiac disorders
Palpitations
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/9 • Up to 2 years
|
20.0%
2/10 • Up to 2 years
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/9 • Up to 2 years
|
20.0%
2/10 • Up to 2 years
|
|
Endocrine disorders
Low Cortisol
|
0.00%
0/9 • Up to 2 years
|
10.0%
1/10 • Up to 2 years
|
|
Eye disorders
Blurred Vision
|
11.1%
1/9 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place