Trial Outcomes & Findings for Durvalumab With or Without Tremelimumab in Metastatic Castration Resistant Prostate Cancer (NCT NCT02788773)
NCT ID: NCT02788773
Last Updated: 2025-05-15
Results Overview
Response evaluated using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) for target and non-target lesions and assessed by CT or MRI: Complete Response (CR), disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions, or in the case of complete remission of the target lesions, when one or more non-target lesions can still be distinguished; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
2 years
Results posted on
2025-05-15
Participant Flow
From December 15, 2016 to October 1, 2019 from cancer centers in Canada.
Participants were randomized to one of two treatment arms after assessment of eligibility.
Participant milestones
| Measure |
Arm A - Durvalumab Plus Tremelimumab
Durvalumab-IV for 60 minutes day 1 every 4 weeks Tremelimumab-IV every 60 minutes day 1, cycles 1-4
Durvalumab
Tremelimumab
|
Arm B - Durvalumab Alone
Durvalumab-IV for 60 minutes day 1 every 4 weeks
Durvalumab
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
13
|
|
Overall Study
COMPLETED
|
39
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Durvalumab With or Without Tremelimumab in Metastatic Castration Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm A - Durvalumab Plus Tremelimumab
n=39 Participants
Durvalumab-IV for 60 minutes day 1 every 4 weeks Tremelimumab-IV every 60 minutes day 1, cycles 1-4
Durvalumab
Tremelimumab
|
Arm B - Durvalumab Alone
n=13 Participants
Durvalumab-IV for 60 minutes day 1 every 4 weeks
Durvalumab
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
n=5 Participants
|
65 years
n=7 Participants
|
70 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
39 participants
n=5 Participants
|
13 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Baseline PSA (prostate-specific antigen) level
Higher than or equal to 2 ng/mL but less than 20 ng/mL
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Baseline PSA (prostate-specific antigen) level
Higher than or equal to 20 ng/mL but less than 100 ng/mL
|
18 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Baseline PSA (prostate-specific antigen) level
Higher than or equal to 100 ng/mL
|
19 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: All enrolled patients
Response evaluated using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) for target and non-target lesions and assessed by CT or MRI: Complete Response (CR), disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions, or in the case of complete remission of the target lesions, when one or more non-target lesions can still be distinguished; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm A - Durvalumab Plus Tremelimumab
n=39 Participants
Durvalumab-IV for 60 minutes day 1 every 4 weeks Tremelimumab-IV every 60 minutes day 1, cycles 1-4
Durvalumab
Tremelimumab
|
Arm B - Durvalumab Alone
n=13 Participants
Durvalumab-IV for 60 minutes day 1 every 4 weeks
Durvalumab
|
|---|---|---|
|
Objective Response Rate Measured by RECIST 1.1
|
7 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: All patients enrolled
Response evaluated using iRECIST (modified Response Evaluation Criteria in Solid Tumours 1.1 for immune-based therapeutics) for target and non-target lesions and assessed by CT or MRI: Complete Response (CR), disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions, or in the case of complete remission of the target lesions, when one or more non-target lesions can still be distinguished; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm A - Durvalumab Plus Tremelimumab
n=39 Participants
Durvalumab-IV for 60 minutes day 1 every 4 weeks Tremelimumab-IV every 60 minutes day 1, cycles 1-4
Durvalumab
Tremelimumab
|
Arm B - Durvalumab Alone
n=13 Participants
Durvalumab-IV for 60 minutes day 1 every 4 weeks
Durvalumab
|
|---|---|---|
|
Objective Response Rate by iRECIST
|
7 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All patients enrolled
A PSA response is defined as 50% fall in PSA from baseline maintained for ≥ 4 weeks, and without evidence of disease progression documented at time of confirmatory values.
Outcome measures
| Measure |
Arm A - Durvalumab Plus Tremelimumab
n=39 Participants
Durvalumab-IV for 60 minutes day 1 every 4 weeks Tremelimumab-IV every 60 minutes day 1, cycles 1-4
Durvalumab
Tremelimumab
|
Arm B - Durvalumab Alone
n=13 Participants
Durvalumab-IV for 60 minutes day 1 every 4 weeks
Durvalumab
|
|---|---|---|
|
Prostate-specific Antigen (PSA) Response Rate
|
7 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All patients enrolled
Time from randomization to objective disease progression documented based on RECIST (Response Evaluation Criteria in Solid Tumours) 1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Arm A - Durvalumab Plus Tremelimumab
n=39 Participants
Durvalumab-IV for 60 minutes day 1 every 4 weeks Tremelimumab-IV every 60 minutes day 1, cycles 1-4
Durvalumab
Tremelimumab
|
Arm B - Durvalumab Alone
n=13 Participants
Durvalumab-IV for 60 minutes day 1 every 4 weeks
Durvalumab
|
|---|---|---|
|
Time to Objective Disease Progression
|
2.79 months
Interval 2.63 to 3.19
|
2.83 months
Interval 1.97 to 2.83
|
Adverse Events
Arm A - Durvalumab Plus Tremelimumab
Serious events: 20 serious events
Other events: 38 other events
Deaths: 34 deaths
Arm B - Durvalumab Alone
Serious events: 5 serious events
Other events: 13 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Arm A - Durvalumab Plus Tremelimumab
n=39 participants at risk
Durvalumab-IV for 60 minutes day 1 every 4 weeks Tremelimumab-IV every 60 minutes day 1, cycles 1-4
Durvalumab
Tremelimumab
|
Arm B - Durvalumab Alone
n=13 participants at risk
Durvalumab-IV for 60 minutes day 1 every 4 weeks
Durvalumab
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Cardiac disorders
Cardiac arrest
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Cardiac disorders
Myocardial infarction
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Endocrine disorders
Adrenal insufficiency
|
5.1%
2/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Endocrine disorders
Hypothyroidism
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Gastrointestinal disorders
Colitis
|
5.1%
2/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
3/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
5.1%
2/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
2/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
General disorders
Edema limbs
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
General disorders
Edema trunk
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
General disorders
Fatigue
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
General disorders
Fever
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
General disorders
Infusion related reaction
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
General disorders
Malaise
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Immune system disorders
Other immune system disorders
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Infections and infestations
Lung infection
|
5.1%
2/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Infections and infestations
Skin infection
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
3/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
10.3%
4/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Investigations
Blood bilirubin increased
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Investigations
Lipase increased
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Investigations
Platelet count decreased
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Investigations
Serum amylase increased
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other neoplasms benign, malignant and unspecified
|
5.1%
2/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Nervous system disorders
Facial muscle weakness
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
5.1%
2/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Psychiatric disorders
Confusion
|
2.6%
1/39 • 2 years
|
15.4%
2/13 • 2 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.6%
1/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Vascular disorders
Lymphedema
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
Other adverse events
| Measure |
Arm A - Durvalumab Plus Tremelimumab
n=39 participants at risk
Durvalumab-IV for 60 minutes day 1 every 4 weeks Tremelimumab-IV every 60 minutes day 1, cycles 1-4
Durvalumab
Tremelimumab
|
Arm B - Durvalumab Alone
n=13 participants at risk
Durvalumab-IV for 60 minutes day 1 every 4 weeks
Durvalumab
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
1/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Ear and labyrinth disorders
Vertigo
|
2.6%
1/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Endocrine disorders
Adrenal insufficiency
|
7.7%
3/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Endocrine disorders
Cushingoid
|
2.6%
1/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Endocrine disorders
Hyperthyroidism
|
7.7%
3/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Endocrine disorders
Hypothyroidism
|
10.3%
4/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Eye disorders
Blurred vision
|
5.1%
2/39 • 2 years
|
15.4%
2/13 • 2 years
|
|
Eye disorders
Dry eye
|
2.6%
1/39 • 2 years
|
15.4%
2/13 • 2 years
|
|
Eye disorders
Watering eyes
|
5.1%
2/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Eye disorders
Other eye disorders
|
2.6%
1/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
25.6%
10/39 • 2 years
|
15.4%
2/13 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
43.6%
17/39 • 2 years
|
61.5%
8/13 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
35.9%
14/39 • 2 years
|
30.8%
4/13 • 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
3/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
2/39 • 2 years
|
15.4%
2/13 • 2 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
48.7%
19/39 • 2 years
|
38.5%
5/13 • 2 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.6%
1/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
35.9%
14/39 • 2 years
|
30.8%
4/13 • 2 years
|
|
Gastrointestinal disorders
Other gastrointestinal disorders
|
5.1%
2/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
General disorders
Chills
|
5.1%
2/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
General disorders
Edema limbs
|
46.2%
18/39 • 2 years
|
53.8%
7/13 • 2 years
|
|
General disorders
Fatigue
|
89.7%
35/39 • 2 years
|
84.6%
11/13 • 2 years
|
|
General disorders
Flu like symptoms
|
10.3%
4/39 • 2 years
|
23.1%
3/13 • 2 years
|
|
General disorders
Malaise
|
5.1%
2/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
2.6%
1/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
General disorders
Pain
|
25.6%
10/39 • 2 years
|
15.4%
2/13 • 2 years
|
|
General disorders
Other general disorders, administration site conditions
|
2.6%
1/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Infections and infestations
Lip infection
|
2.6%
1/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Infections and infestations
Lung infection
|
2.6%
1/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Infections and infestations
Skin infection
|
10.3%
4/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Infections and infestations
Upper respiratory infection
|
5.1%
2/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
10.3%
4/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Infections and infestations
Other infections and infestations
|
2.6%
1/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Injury, poisoning and procedural complications
Bruising
|
7.7%
3/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
3/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
61.5%
24/39 • 2 years
|
53.8%
7/13 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.1%
2/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.5%
8/39 • 2 years
|
15.4%
2/13 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
35.9%
14/39 • 2 years
|
46.2%
6/13 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.5%
8/39 • 2 years
|
38.5%
5/13 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.6%
1/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.1%
2/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
2.6%
1/39 • 2 years
|
15.4%
2/13 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
7.7%
3/39 • 2 years
|
15.4%
2/13 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.5%
8/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.1%
2/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.5%
8/39 • 2 years
|
46.2%
6/13 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Other musculoskeletal and connective tissue disorder
|
5.1%
2/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
10.3%
4/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Nervous system disorders
Dizziness
|
10.3%
4/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Nervous system disorders
Dysgeusia
|
7.7%
3/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Nervous system disorders
Facial muscle weakness
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Nervous system disorders
Headache
|
15.4%
6/39 • 2 years
|
15.4%
2/13 • 2 years
|
|
Nervous system disorders
Paresthesia
|
7.7%
3/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.6%
10/39 • 2 years
|
15.4%
2/13 • 2 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Nervous system disorders
Tremor
|
5.1%
2/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Psychiatric disorders
Agitation
|
5.1%
2/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Psychiatric disorders
Confusion
|
5.1%
2/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Psychiatric disorders
Insomnia
|
5.1%
2/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Renal and urinary disorders
Hematuria
|
23.1%
9/39 • 2 years
|
15.4%
2/13 • 2 years
|
|
Renal and urinary disorders
Urinary retention
|
5.1%
2/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
5.1%
2/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Renal and urinary disorders
Other renal and urinary disorders
|
7.7%
3/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Reproductive system and breast disorders
Genital edema
|
2.6%
1/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
12.8%
5/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.2%
11/39 • 2 years
|
15.4%
2/13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.8%
12/39 • 2 years
|
53.8%
7/13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
3/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
3/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.6%
1/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.1%
2/39 • 2 years
|
15.4%
2/13 • 2 years
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
5.1%
2/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.9%
7/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.6%
1/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.5%
8/39 • 2 years
|
15.4%
2/13 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Skin and subcutaneous tissue disorders
Other skin and subcutaneous tissue disorders
|
7.7%
3/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Vascular disorders
Hot flashes
|
5.1%
2/39 • 2 years
|
0.00%
0/13 • 2 years
|
|
Vascular disorders
Hypertension
|
2.6%
1/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Vascular disorders
Lymphedema
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/39 • 2 years
|
7.7%
1/13 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place