Trial Outcomes & Findings for PCI-32765 for Special Cases of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT NCT01500733)
NCT ID: NCT01500733
Last Updated: 2024-09-19
Results Overview
The primary endpoint was response after 6 cycles of therapy. Overall response rate was calculated as complete response plus partial response, based on the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2008 criteria.as follows: Complete response (CR): all group A and group B criteria are met * Group A criteria: resolution of enlarged lymph nodes, normal size spleen and liver, absolute lymphocyte count \< 4,000/uL, normocellular bone marrow with \< 30% lymphocytes without nodules * Group B criteria: improved blood count (platelet count \> 100,000/uL, hemoglobin \> 11.0 g/dL, neutrophils \> 1,500/uL) Partial response (PR): at least 2 of the group A criteria plus one of the group B criteria are met * Group A criteria: \>=50% decrease in target lymph nodes, \>=50% decrease in spleen size, \>=50% decrease in liver size, 50% reduction in marrow infiltrates * Group B criteria: platelet count \> 100,000/uL, hemoglobin \> 11.0 g/dL, neutrophils \> 1,500/uL
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
86 participants
Primary outcome timeframe
6 months
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Elderly Cohort
Chronic lymphocytic leukemia patients 65 years or older
|
TP53 Cohort
Chronic lymphocytic leukemia patients having TP53 aberration, either due to deletion of chromosome 17p or TP53 mutation
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
51
|
|
Overall Study
COMPLETED
|
33
|
48
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PCI-32765 for Special Cases of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Baseline characteristics by cohort
| Measure |
Elderly Cohort
n=35 Participants
Chronic lymphocytic leukemia patients 65 years or older
|
TP53 Cohort
n=51 Participants
Chronic lymphocytic leukemia patients having TP53 aberration, either due to deletion of chromosome 17p or TP53 mutation
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
34 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 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
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The analyses included only those subjects who received ibrutinib, and completed 6 cycles of therapy.
The primary endpoint was response after 6 cycles of therapy. Overall response rate was calculated as complete response plus partial response, based on the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2008 criteria.as follows: Complete response (CR): all group A and group B criteria are met * Group A criteria: resolution of enlarged lymph nodes, normal size spleen and liver, absolute lymphocyte count \< 4,000/uL, normocellular bone marrow with \< 30% lymphocytes without nodules * Group B criteria: improved blood count (platelet count \> 100,000/uL, hemoglobin \> 11.0 g/dL, neutrophils \> 1,500/uL) Partial response (PR): at least 2 of the group A criteria plus one of the group B criteria are met * Group A criteria: \>=50% decrease in target lymph nodes, \>=50% decrease in spleen size, \>=50% decrease in liver size, 50% reduction in marrow infiltrates * Group B criteria: platelet count \> 100,000/uL, hemoglobin \> 11.0 g/dL, neutrophils \> 1,500/uL
Outcome measures
| Measure |
Elderly Cohort
n=33 Participants
Chronic lymphocytic leukemia patients 65 years or older
|
TP53 Cohort
n=48 Participants
Chronic lymphocytic leukemia patients having TP53 aberration, either due to deletion of chromosome 17p or TP53 mutation
|
|---|---|---|
|
Overall Response Rate at 6 Months
|
93.9 percentage of participants
Interval 79.8 to 99.3
|
95.8 percentage of participants
Interval 85.7 to 99.5
|
Adverse Events
Elderly Cohort
Serious events: 25 serious events
Other events: 35 other events
Deaths: 5 deaths
TP53 Cohort
Serious events: 29 serious events
Other events: 51 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Elderly Cohort
n=35 participants at risk
Chronic lymphocytic leukemia patients 65 years or older
|
TP53 Cohort
n=51 participants at risk
Chronic lymphocytic leukemia patients having T53 aberration, either due to deletion of chromosome 17p or TP53 mutation
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.7%
2/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Cardiac disorders
Atrial fibrillation
|
8.6%
3/35 • 69 months
|
7.8%
4/51 • 69 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
2.9%
1/35 • 69 months
|
5.9%
3/51 • 69 months
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Cardiac disorders
Heart failure
|
2.9%
1/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Cardiac disorders
Stroke
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Eye disorders
Retinopathy
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Gastrointestinal disorders
Dysphagia
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Gastrointestinal disorders
Gastric ulcer
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
General disorders
Death, NOS
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
General disorders
Edema limbs
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
General disorders
Fever
|
0.00%
0/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Immune system disorders
Immune system disorders - Other, specify
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
14.3%
5/35 • 69 months
|
13.7%
7/51 • 69 months
|
|
Infections and infestations
Lung infection
|
25.7%
9/35 • 69 months
|
13.7%
7/51 • 69 months
|
|
Infections and infestations
Pleural infection
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Infections and infestations
Prostate infection
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/35 • 69 months
|
5.9%
3/51 • 69 months
|
|
Infections and infestations
Skin infection
|
2.9%
1/35 • 69 months
|
5.9%
3/51 • 69 months
|
|
Infections and infestations
Upper respiratory infection
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
31.4%
11/35 • 69 months
|
17.6%
9/51 • 69 months
|
|
Nervous system disorders
Amnesia
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Psychiatric disorders
Delirium
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
Other adverse events
| Measure |
Elderly Cohort
n=35 participants at risk
Chronic lymphocytic leukemia patients 65 years or older
|
TP53 Cohort
n=51 participants at risk
Chronic lymphocytic leukemia patients having T53 aberration, either due to deletion of chromosome 17p or TP53 mutation
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
82.9%
29/35 • 69 months
|
78.4%
40/51 • 69 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/35 • 69 months
|
15.7%
8/51 • 69 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
34.3%
12/35 • 69 months
|
39.2%
20/51 • 69 months
|
|
Blood and lymphatic system disorders
Lymph node pain
|
5.7%
2/35 • 69 months
|
15.7%
8/51 • 69 months
|
|
Cardiac disorders
Atrial fibrillation
|
20.0%
7/35 • 69 months
|
15.7%
8/51 • 69 months
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/35 • 69 months
|
5.9%
3/51 • 69 months
|
|
Cardiac disorders
Chest pain - cardiac
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Cardiac disorders
Hypertension
|
5.7%
2/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Cardiac disorders
Palpitations
|
20.0%
7/35 • 69 months
|
19.6%
10/51 • 69 months
|
|
Cardiac disorders
Pericardial effusion
|
5.7%
2/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Cardiac disorders
Sinus bradycardia
|
17.1%
6/35 • 69 months
|
17.6%
9/51 • 69 months
|
|
Cardiac disorders
Sinus tachycardia
|
5.7%
2/35 • 69 months
|
11.8%
6/51 • 69 months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
14.3%
5/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Ear and labyrinth disorders
Ear pain
|
2.9%
1/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Ear and labyrinth disorders
External ear inflammation
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
11.4%
4/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Ear and labyrinth disorders
Tinnitus
|
2.9%
1/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Ear and labyrinth disorders
Vertigo
|
8.6%
3/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
2.9%
1/35 • 69 months
|
5.9%
3/51 • 69 months
|
|
Endocrine disorders
Hypothyroidism
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Eye disorders
Blurred vision
|
8.6%
3/35 • 69 months
|
7.8%
4/51 • 69 months
|
|
Eye disorders
Cataract
|
14.3%
5/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Eye disorders
Conjunctivitis
|
2.9%
1/35 • 69 months
|
9.8%
5/51 • 69 months
|
|
Eye disorders
Dry eye
|
5.7%
2/35 • 69 months
|
9.8%
5/51 • 69 months
|
|
Eye disorders
Eye disorders - Other, specify
|
25.7%
9/35 • 69 months
|
27.5%
14/51 • 69 months
|
|
Eye disorders
Eye pain
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Eye disorders
Floaters
|
5.7%
2/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Eye disorders
Glaucoma
|
2.9%
1/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Eye disorders
Scleral disorder
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Eye disorders
Uveitis
|
0.00%
0/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Eye disorders
Watering eyes
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Gastrointestinal disorders
Abdominal distension
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
5/35 • 69 months
|
13.7%
7/51 • 69 months
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Gastrointestinal disorders
Anorexia
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Gastrointestinal disorders
Ascites
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Gastrointestinal disorders
Bloating
|
5.7%
2/35 • 69 months
|
7.8%
4/51 • 69 months
|
|
Gastrointestinal disorders
Cheilitis
|
2.9%
1/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Gastrointestinal disorders
Colitis
|
5.7%
2/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Gastrointestinal disorders
Constipation
|
17.1%
6/35 • 69 months
|
5.9%
3/51 • 69 months
|
|
Gastrointestinal disorders
Dental caries
|
2.9%
1/35 • 69 months
|
5.9%
3/51 • 69 months
|
|
Gastrointestinal disorders
Diarrhea
|
71.4%
25/35 • 69 months
|
68.6%
35/51 • 69 months
|
|
Gastrointestinal disorders
Dry mouth
|
11.4%
4/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
1/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Gastrointestinal disorders
Dysphagia
|
5.7%
2/35 • 69 months
|
7.8%
4/51 • 69 months
|
|
Gastrointestinal disorders
Flatulence
|
5.7%
2/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Gastrointestinal disorders
Gastritis
|
2.9%
1/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
20.0%
7/35 • 69 months
|
13.7%
7/51 • 69 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
31.4%
11/35 • 69 months
|
25.5%
13/51 • 69 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Gastrointestinal disorders
Mucositis oral
|
17.1%
6/35 • 69 months
|
23.5%
12/51 • 69 months
|
|
Gastrointestinal disorders
Nausea
|
17.1%
6/35 • 69 months
|
23.5%
12/51 • 69 months
|
|
Gastrointestinal disorders
Oral hemorrhage
|
8.6%
3/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Gastrointestinal disorders
Periodontal disease
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Gastrointestinal disorders
Vomiting
|
8.6%
3/35 • 69 months
|
15.7%
8/51 • 69 months
|
|
General disorders
Chills
|
22.9%
8/35 • 69 months
|
23.5%
12/51 • 69 months
|
|
General disorders
Dizziness
|
0.00%
0/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
General disorders
Edema face
|
2.9%
1/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
General disorders
Edema limbs
|
31.4%
11/35 • 69 months
|
35.3%
18/51 • 69 months
|
|
General disorders
Fatigue
|
34.3%
12/35 • 69 months
|
45.1%
23/51 • 69 months
|
|
General disorders
Fever
|
20.0%
7/35 • 69 months
|
31.4%
16/51 • 69 months
|
|
General disorders
Flu like symptoms
|
8.6%
3/35 • 69 months
|
13.7%
7/51 • 69 months
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
14.3%
5/35 • 69 months
|
13.7%
7/51 • 69 months
|
|
General disorders
Headache
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
General disorders
Infusion site extravasation
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
General disorders
Localized edema
|
0.00%
0/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
General disorders
Malaise
|
2.9%
1/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
General disorders
Neck edema
|
0.00%
0/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
General disorders
Non-cardiac chest pain
|
8.6%
3/35 • 69 months
|
7.8%
4/51 • 69 months
|
|
General disorders
Pain
|
42.9%
15/35 • 69 months
|
37.3%
19/51 • 69 months
|
|
General disorders
Weight loss
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
5.7%
2/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Immune system disorders
Allergic reaction
|
2.9%
1/35 • 69 months
|
9.8%
5/51 • 69 months
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Infections and infestations
Bronchial infection
|
11.4%
4/35 • 69 months
|
13.7%
7/51 • 69 months
|
|
Infections and infestations
Eye infection
|
2.9%
1/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Infections and infestations
Gum infection
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
40.0%
14/35 • 69 months
|
56.9%
29/51 • 69 months
|
|
Infections and infestations
Laryngitis
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Infections and infestations
Lung infection
|
22.9%
8/35 • 69 months
|
9.8%
5/51 • 69 months
|
|
Infections and infestations
Nail infection
|
5.7%
2/35 • 69 months
|
5.9%
3/51 • 69 months
|
|
Infections and infestations
Otitis externa
|
5.7%
2/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Infections and infestations
Papulopustular rash
|
17.1%
6/35 • 69 months
|
7.8%
4/51 • 69 months
|
|
Infections and infestations
Paronychia
|
2.9%
1/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Infections and infestations
Rash pustular
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Infections and infestations
Rhinitis infective
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Infections and infestations
Sinusitis
|
40.0%
14/35 • 69 months
|
27.5%
14/51 • 69 months
|
|
Infections and infestations
Skin infection
|
25.7%
9/35 • 69 months
|
19.6%
10/51 • 69 months
|
|
Infections and infestations
Upper respiratory infection
|
48.6%
17/35 • 69 months
|
35.3%
18/51 • 69 months
|
|
Infections and infestations
Urinary tract infection
|
14.3%
5/35 • 69 months
|
13.7%
7/51 • 69 months
|
|
Infections and infestations
Vaginal infection
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Infections and infestations
Vulval infection
|
2.9%
1/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Injury, poisoning and procedural complications
Bruising
|
71.4%
25/35 • 69 months
|
66.7%
34/51 • 69 months
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
7/35 • 69 months
|
17.6%
9/51 • 69 months
|
|
Injury, poisoning and procedural complications
Fracture
|
11.4%
4/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
11.4%
4/35 • 69 months
|
15.7%
8/51 • 69 months
|
|
Injury, poisoning and procedural complications
Intraoperative skin injury
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
11.4%
4/35 • 69 months
|
9.8%
5/51 • 69 months
|
|
Investigations
Alanine aminotransferase increased
|
34.3%
12/35 • 69 months
|
43.1%
22/51 • 69 months
|
|
Investigations
Alkaline phosphatase increased
|
28.6%
10/35 • 69 months
|
23.5%
12/51 • 69 months
|
|
Investigations
Aspartate aminotransferase increased
|
37.1%
13/35 • 69 months
|
29.4%
15/51 • 69 months
|
|
Investigations
Blood bilirubin increased
|
25.7%
9/35 • 69 months
|
35.3%
18/51 • 69 months
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Investigations
CPK increased
|
14.3%
5/35 • 69 months
|
11.8%
6/51 • 69 months
|
|
Investigations
Creatinine increased
|
48.6%
17/35 • 69 months
|
54.9%
28/51 • 69 months
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/35 • 69 months
|
5.9%
3/51 • 69 months
|
|
Investigations
Haptoglobin decreased
|
8.6%
3/35 • 69 months
|
7.8%
4/51 • 69 months
|
|
Investigations
Hypercalcemia
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Investigations
Hypermagnesemia
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Investigations
Hypernatremia
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Investigations
Hypoalbuminemia
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Investigations
Hyponatremia
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Investigations
INR increased
|
11.4%
4/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Investigations
Investigations - Other, specify
|
22.9%
8/35 • 69 months
|
9.8%
5/51 • 69 months
|
|
Investigations
Lipase increased
|
0.00%
0/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Investigations
Lymphocyte count decreased
|
42.9%
15/35 • 69 months
|
37.3%
19/51 • 69 months
|
|
Investigations
Lymphocyte count increased
|
91.4%
32/35 • 69 months
|
94.1%
48/51 • 69 months
|
|
Investigations
Neutrophil count decreased
|
57.1%
20/35 • 69 months
|
66.7%
34/51 • 69 months
|
|
Investigations
Platelet count decreased
|
80.0%
28/35 • 69 months
|
74.5%
38/51 • 69 months
|
|
Investigations
Weight gain
|
48.6%
17/35 • 69 months
|
54.9%
28/51 • 69 months
|
|
Investigations
Weight loss
|
20.0%
7/35 • 69 months
|
21.6%
11/51 • 69 months
|
|
Investigations
White blood cell decreased
|
31.4%
11/35 • 69 months
|
21.6%
11/51 • 69 months
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Metabolism and nutrition disorders
Anorexia
|
28.6%
10/35 • 69 months
|
15.7%
8/51 • 69 months
|
|
Metabolism and nutrition disorders
Dehydration
|
5.7%
2/35 • 69 months
|
5.9%
3/51 • 69 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.7%
2/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
5/35 • 69 months
|
19.6%
10/51 • 69 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.0%
7/35 • 69 months
|
9.8%
5/51 • 69 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
14.3%
5/35 • 69 months
|
13.7%
7/51 • 69 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
42.9%
15/35 • 69 months
|
33.3%
17/51 • 69 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
42.9%
15/35 • 69 months
|
29.4%
15/51 • 69 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
65.7%
23/35 • 69 months
|
51.0%
26/51 • 69 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
48.6%
17/35 • 69 months
|
45.1%
23/51 • 69 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.9%
1/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.1%
6/35 • 69 months
|
13.7%
7/51 • 69 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.6%
3/35 • 69 months
|
11.8%
6/51 • 69 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
22.9%
8/35 • 69 months
|
19.6%
10/51 • 69 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.7%
9/35 • 69 months
|
25.5%
13/51 • 69 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Metabolism and nutrition disorders
Obesity
|
14.3%
5/35 • 69 months
|
15.7%
8/51 • 69 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
45.7%
16/35 • 69 months
|
45.1%
23/51 • 69 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
31.4%
11/35 • 69 months
|
11.8%
6/51 • 69 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.9%
8/35 • 69 months
|
15.7%
8/51 • 69 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.6%
3/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
8.6%
3/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
11.4%
4/35 • 69 months
|
19.6%
10/51 • 69 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal deformity
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
42.9%
15/35 • 69 months
|
37.3%
19/51 • 69 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.4%
4/35 • 69 months
|
7.8%
4/51 • 69 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
5/35 • 69 months
|
39.2%
20/51 • 69 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
31.4%
11/35 • 69 months
|
15.7%
8/51 • 69 months
|
|
Nervous system disorders
Amnesia
|
2.9%
1/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Nervous system disorders
Dizziness
|
8.6%
3/35 • 69 months
|
31.4%
16/51 • 69 months
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Nervous system disorders
Headache
|
17.1%
6/35 • 69 months
|
19.6%
10/51 • 69 months
|
|
Nervous system disorders
Lethargy
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Nervous system disorders
Memory impairment
|
2.9%
1/35 • 69 months
|
5.9%
3/51 • 69 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
5.7%
2/35 • 69 months
|
5.9%
3/51 • 69 months
|
|
Nervous system disorders
Neuralgia
|
2.9%
1/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Nervous system disorders
Paresthesia
|
11.4%
4/35 • 69 months
|
5.9%
3/51 • 69 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.6%
3/35 • 69 months
|
5.9%
3/51 • 69 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Nervous system disorders
Sinus pain
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Nervous system disorders
Tremor
|
5.7%
2/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/35 • 69 months
|
5.9%
3/51 • 69 months
|
|
Psychiatric disorders
Confusion
|
2.9%
1/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Psychiatric disorders
Insomnia
|
11.4%
4/35 • 69 months
|
5.9%
3/51 • 69 months
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Renal and urinary disorders
Acute kidney injury
|
2.9%
1/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Renal and urinary disorders
Hematuria
|
17.1%
6/35 • 69 months
|
19.6%
10/51 • 69 months
|
|
Renal and urinary disorders
Hemoglobinuria
|
2.9%
1/35 • 69 months
|
7.8%
4/51 • 69 months
|
|
Renal and urinary disorders
Proteinuria
|
5.7%
2/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
11.4%
4/35 • 69 months
|
9.8%
5/51 • 69 months
|
|
Renal and urinary disorders
Renal colic
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Renal and urinary disorders
Urinary frequency
|
5.7%
2/35 • 69 months
|
5.9%
3/51 • 69 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Renal and urinary disorders
Urinary retention
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
2.9%
1/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
5.7%
2/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.7%
2/35 • 69 months
|
7.8%
4/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
42.9%
15/35 • 69 months
|
37.3%
19/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.6%
10/35 • 69 months
|
39.2%
20/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
5/35 • 69 months
|
19.6%
10/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.7%
2/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.6%
3/35 • 69 months
|
5.9%
3/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
28.6%
10/35 • 69 months
|
21.6%
11/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.7%
2/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.7%
2/35 • 69 months
|
5.9%
3/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
20.0%
7/35 • 69 months
|
13.7%
7/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
28.6%
10/35 • 69 months
|
19.6%
10/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
17.1%
6/35 • 69 months
|
13.7%
7/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
8.6%
3/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
37.1%
13/35 • 69 months
|
21.6%
11/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.9%
1/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.6%
3/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.6%
3/35 • 69 months
|
7.8%
4/51 • 69 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.9%
1/35 • 69 months
|
9.8%
5/51 • 69 months
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
2.9%
1/35 • 69 months
|
5.9%
3/51 • 69 months
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
5.7%
2/35 • 69 months
|
11.8%
6/51 • 69 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.1%
6/35 • 69 months
|
9.8%
5/51 • 69 months
|
|
Skin and subcutaneous tissue disorders
Purpura
|
14.3%
5/35 • 69 months
|
7.8%
4/51 • 69 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
8.6%
3/35 • 69 months
|
7.8%
4/51 • 69 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
51.4%
18/35 • 69 months
|
49.0%
25/51 • 69 months
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
2.9%
1/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
77.1%
27/35 • 69 months
|
78.4%
40/51 • 69 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.9%
1/35 • 69 months
|
7.8%
4/51 • 69 months
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
14.3%
5/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.7%
2/35 • 69 months
|
0.00%
0/51 • 69 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
31.4%
11/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Vascular disorders
Hematoma
|
8.6%
3/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Vascular disorders
Hot flashes
|
2.9%
1/35 • 69 months
|
13.7%
7/51 • 69 months
|
|
Vascular disorders
Hypertension
|
34.3%
12/35 • 69 months
|
45.1%
23/51 • 69 months
|
|
Vascular disorders
Hypotension
|
2.9%
1/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Vascular disorders
Lymphedema
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Vascular disorders
Phlebitis
|
0.00%
0/35 • 69 months
|
3.9%
2/51 • 69 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/35 • 69 months
|
2.0%
1/51 • 69 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/35 • 69 months
|
3.9%
2/51 • 69 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place