Trial Outcomes & Findings for Nivolumab for Recurrent or Progressive IDH Mutant Gliomas (NCT NCT03557359)
NCT ID: NCT03557359
Last Updated: 2026-06-10
Results Overview
The overall response rate is defined as the percentage of patients with a reduction in tumor size while on treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Throughout treatment duration or until progressive disease, unacceptable toxicity, or withdrawal of consent, up to 2 years
Results posted on
2026-06-10
Participant Flow
Thirty-five patients were enrolled and 33 patients received at least one dose of nivolumab. Two patients were lost to follow up before beginning treatment. Thirty-two patients completed the full 2-year treatment and one patient discontinued after 23 months due to Grade 2 transaminitis. Thirty-three patients were included in the analysis.
Participant milestones
| Measure |
Nivolumab 240 mg
Nivolumab 240 mg will be given every 2 weeks for 8 cycles. Nivolumab will be administered as a 30-minute infusion. A finite treatment duration with immune therapies in this participant population remains an area of ongoing research; therefore the treatment duration chosen was 2 years.
Nivolumab: Nivolumab (Opdivo®) is a human monoclonal antibody (HuMAb; immunoglobulin G4 (IgG4)- S228P) that targets the PD-1 cluster of differentiation 279 (CD279) cell surface membrane receptor.
|
Nivolumab 480 mg
Beginning with Cycle 9, Nivolumab 480 mg will be given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab will be administered as a 30-minute infusion. A finite treatment duration with immune therapies in this participant population remains an area of ongoing research; therefore the treatment duration chosen was 2 years.
Nivolumab: Nivolumab (Opdivo®) is a human monoclonal antibody (HuMAb; immunoglobulin G4 (IgG4)- S228P) that targets the PD-1 cluster of differentiation 279 (CD279) cell surface membrane receptor.
|
|---|---|---|
|
Dose 1: 240 mg
STARTED
|
33
|
0
|
|
Dose 1: 240 mg
COMPLETED
|
32
|
0
|
|
Dose 1: 240 mg
NOT COMPLETED
|
1
|
0
|
|
Dose 2: 480 mg
STARTED
|
0
|
13
|
|
Dose 2: 480 mg
COMPLETED
|
0
|
13
|
|
Dose 2: 480 mg
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Nivolumab 240 mg
Nivolumab 240 mg will be given every 2 weeks for 8 cycles. Nivolumab will be administered as a 30-minute infusion. A finite treatment duration with immune therapies in this participant population remains an area of ongoing research; therefore the treatment duration chosen was 2 years.
Nivolumab: Nivolumab (Opdivo®) is a human monoclonal antibody (HuMAb; immunoglobulin G4 (IgG4)- S228P) that targets the PD-1 cluster of differentiation 279 (CD279) cell surface membrane receptor.
|
Nivolumab 480 mg
Beginning with Cycle 9, Nivolumab 480 mg will be given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab will be administered as a 30-minute infusion. A finite treatment duration with immune therapies in this participant population remains an area of ongoing research; therefore the treatment duration chosen was 2 years.
Nivolumab: Nivolumab (Opdivo®) is a human monoclonal antibody (HuMAb; immunoglobulin G4 (IgG4)- S228P) that targets the PD-1 cluster of differentiation 279 (CD279) cell surface membrane receptor.
|
|---|---|---|
|
Dose 1: 240 mg
Adverse Event
|
1
|
0
|
Baseline Characteristics
Nivolumab for Recurrent or Progressive IDH Mutant Gliomas
Baseline characteristics by cohort
| Measure |
Nivolumab
n=35 Participants
Nivolumab 240 mg will be given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg will be given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab will be administered as a 30-minute infusion. A finite treatment duration with immune therapies in this participant population remains an area of ongoing research; therefore the treatment duration chosen was 2 years.
Nivolumab: Nivolumab (Opdivo®) is a human monoclonal antibody (HuMAb; immunoglobulin G4 (IgG4)- S228P) that targets the PD-1 cluster of differentiation 279 (CD279) cell surface membrane receptor.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=9 Participants
|
|
Age, Continuous
|
44.5 Years
n=9 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=9 Participants
|
|
Recurrent or progressive IDH mutant (grades 2, 3 or 4) gliomas in subjects 18 years of age or older
|
35 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Throughout treatment duration or until progressive disease, unacceptable toxicity, or withdrawal of consent, up to 2 yearsThe overall response rate is defined as the percentage of patients with a reduction in tumor size while on treatment.
Outcome measures
| Measure |
Nivolumab
n=33 Participants
Nivolumab 240 mg will be given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg will be given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab will be administered as a 30-minute infusion. A finite treatment duration with immune therapies in this participant population remains an area of ongoing research; therefore the treatment duration chosen was 2 years.
Nivolumab: Nivolumab (Opdivo®) is a human monoclonal antibody (HuMAb; immunoglobulin G4 (IgG4)- S228P) that targets the PD-1 cluster of differentiation 279 (CD279) cell surface membrane receptor.
|
|---|---|
|
Overall Response Rate
|
9 percent
|
SECONDARY outcome
Timeframe: Until the first date that progressive disease is objectively documented or until study completion, up to 54 monthsThe duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Outcome measures
| Measure |
Nivolumab
n=33 Participants
Nivolumab 240 mg will be given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg will be given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab will be administered as a 30-minute infusion. A finite treatment duration with immune therapies in this participant population remains an area of ongoing research; therefore the treatment duration chosen was 2 years.
Nivolumab: Nivolumab (Opdivo®) is a human monoclonal antibody (HuMAb; immunoglobulin G4 (IgG4)- S228P) that targets the PD-1 cluster of differentiation 279 (CD279) cell surface membrane receptor.
|
|---|---|
|
Duration of Response
|
33 months
Interval 24.4 to 53.9
|
SECONDARY outcome
Timeframe: Until death or study completion, up to 54 monthsPFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Participants discontinuing study treatment will remain on study for documentation of progression and death.
Outcome measures
| Measure |
Nivolumab
n=33 Participants
Nivolumab 240 mg will be given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg will be given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab will be administered as a 30-minute infusion. A finite treatment duration with immune therapies in this participant population remains an area of ongoing research; therefore the treatment duration chosen was 2 years.
Nivolumab: Nivolumab (Opdivo®) is a human monoclonal antibody (HuMAb; immunoglobulin G4 (IgG4)- S228P) that targets the PD-1 cluster of differentiation 279 (CD279) cell surface membrane receptor.
|
|---|---|
|
Progression-Free Survival (PFS)
|
3.6 months
Interval 0.0 to 9.2
|
SECONDARY outcome
Timeframe: Until death or study completion, up to 54 monthsOS is defined as the time from the first dose of nivolumab to death due to any cause. All other participants will be censored at the last date known to be alive.
Outcome measures
| Measure |
Nivolumab
n=33 Participants
Nivolumab 240 mg will be given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg will be given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab will be administered as a 30-minute infusion. A finite treatment duration with immune therapies in this participant population remains an area of ongoing research; therefore the treatment duration chosen was 2 years.
Nivolumab: Nivolumab (Opdivo®) is a human monoclonal antibody (HuMAb; immunoglobulin G4 (IgG4)- S228P) that targets the PD-1 cluster of differentiation 279 (CD279) cell surface membrane receptor.
|
|---|---|
|
Overall Survival (OS)
|
29.1 months
Interval 21.5 to 36.7
|
Adverse Events
Nivolumab 240 mg
Serious events: 9 serious events
Other events: 29 other events
Deaths: 25 deaths
Nivolumab 480 mg
Serious events: 4 serious events
Other events: 13 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Nivolumab 240 mg
n=33 participants at risk
Nivolumab 240 mg will be given every 2 weeks for 8 cycles.
|
Nivolumab 480 mg
n=13 participants at risk
Beginning with Cycle 9, Nivolumab 480 mg will be given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Vascular disorders
Hypotension
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Infections and infestations
Lung Infection
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Nervous system disorders
Headache
|
3.0%
1/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - Right Side
|
3.0%
1/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Nervous system disorders
Stroke
|
0.00%
0/33 • 54 months
|
15.4%
2/13 • 54 months
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Nervous system disorders
Seizure
|
9.1%
3/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
6.1%
2/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - Left Side
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
Other adverse events
| Measure |
Nivolumab 240 mg
n=33 participants at risk
Nivolumab 240 mg will be given every 2 weeks for 8 cycles.
|
Nivolumab 480 mg
n=13 participants at risk
Beginning with Cycle 9, Nivolumab 480 mg will be given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.0%
1/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
General disorders
Edema limbs
|
3.0%
1/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Nervous system disorders
Facial muscle weakness
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Injury, poisoning and procedural complications
Fall
|
18.2%
6/33 • 54 months
|
23.1%
3/13 • 54 months
|
|
General disorders
Fatigue
|
27.3%
9/33 • 54 months
|
23.1%
3/13 • 54 months
|
|
Eye disorders
Flashing lights
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
General disorders
Gait disturbance
|
3.0%
1/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
3.0%
1/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.0%
1/33 • 54 months
|
15.4%
2/13 • 54 months
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Nervous system disorders
Headache
|
24.2%
8/33 • 54 months
|
23.1%
3/13 • 54 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Vascular disorders
Hot flashes
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Vascular disorders
Hypertension
|
6.1%
2/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.1%
2/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Psychiatric disorders
Insomnia
|
9.1%
3/33 • 54 months
|
15.4%
2/13 • 54 months
|
|
Nervous system disorders
Lethargy
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Psychiatric disorders
Libido decreased
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Gastrointestinal disorders
Lip pain
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Investigations
Lipase increased
|
3.0%
1/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Investigations
Lymphocyte count decreased
|
18.2%
6/33 • 54 months
|
15.4%
2/13 • 54 months
|
|
Nervous system disorders
Memory impairment
|
6.1%
2/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Infections and infestations
Mucosal infection
|
3.0%
1/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
12.1%
4/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
3.0%
1/33 • 54 months
|
15.4%
2/13 • 54 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/33 • 54 months
|
23.1%
3/13 • 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/33 • 54 months
|
15.4%
2/13 • 54 months
|
|
Gastrointestinal disorders
Nausea
|
9.1%
3/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
12.1%
4/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Infections and infestations
Neutrophil count decreased
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
General disorders
Pain
|
6.1%
2/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.1%
2/33 • 54 months
|
15.4%
2/13 • 54 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Nervous system disorders
Paresthesia
|
6.1%
2/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Infections and infestations
Pharyngitis
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Investigations
Platelet count decreased
|
6.1%
2/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
3/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.0%
1/33 • 54 months
|
23.1%
3/13 • 54 months
|
|
Reproductive system and breast disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
3.0%
1/33 • 54 months
|
15.4%
2/13 • 54 months
|
|
Psychiatric disorders
Restlessness
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Nervous system disorders
Seizure
|
9.1%
3/33 • 54 months
|
23.1%
3/13 • 54 months
|
|
Investigations
Serum amylase increased
|
6.1%
2/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
6.1%
2/33 • 54 months
|
15.4%
2/13 • 54 months
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Nervous system disorders
Stroke
|
0.00%
0/33 • 54 months
|
15.4%
2/13 • 54 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Ear and labyrinth disorders
Tinnitus
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Infections and infestations
Tooth infection
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Infections and infestations
Upper respiratory infection
|
6.1%
2/33 • 54 months
|
23.1%
3/13 • 54 months
|
|
Renal and urinary disorders
Urinary frequency
|
6.1%
2/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Renal and urinary disorders
Urinary incontinence
|
3.0%
1/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Infections and infestations
Urinary tract infection
|
6.1%
2/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Renal and urinary disorders
Urinary urgency
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Investigations
Weight gain
|
3.0%
1/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Investigations
Weight loss
|
0.00%
0/33 • 54 months
|
15.4%
2/13 • 54 months
|
|
Investigations
White blood cell decreased
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Cardiac disorders
Sinus tachycardia
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Gastrointestinal disorders
Dysphagia
|
6.1%
2/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Nervous system disorders
Dysphasia
|
12.1%
4/33 • 54 months
|
15.4%
2/13 • 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
3/33 • 54 months
|
15.4%
2/13 • 54 months
|
|
Psychiatric disorders
Depression
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Gastrointestinal disorders
Diarrhea
|
15.2%
5/33 • 54 months
|
15.4%
2/13 • 54 months
|
|
Nervous system disorders
Dizziness
|
12.1%
4/33 • 54 months
|
16.7%
2/12 • 54 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.0%
1/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.1%
2/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Psychiatric disorders
Agitation
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Investigations
Alanine aminotransferase increased
|
21.2%
7/33 • 54 months
|
15.4%
2/13 • 54 months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Immune system disorders
Allergic reaction
|
6.1%
2/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Alopecia
|
3.0%
1/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/33 • 54 months
|
15.4%
2/13 • 54 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/33 • 54 months
|
15.4%
2/13 • 54 months
|
|
Investigations
Aspartate aminotransferase increased
|
12.1%
4/33 • 54 months
|
23.1%
3/13 • 54 months
|
|
Immune system disorders
Autoimmune disorder
|
3.0%
1/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
3/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Investigations
Blood bilirubin increased
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Eye disorders
Blurred vision
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Injury, poisoning and procedural complications
Bruising
|
6.1%
2/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/33 • 54 months
|
7.7%
1/13 • 54 months
|
|
Cardiac disorders
Chest pain - cardiac
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Nervous system disorders
Cognitive disturbance
|
3.0%
1/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Psychiatric disorders
Confusion
|
12.1%
4/33 • 54 months
|
0.00%
0/13 • 54 months
|
|
Gastrointestinal disorders
Constipation
|
6.1%
2/33 • 54 months
|
7.7%
1/13 • 54 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place