Trial Outcomes & Findings for Ofatumumab, Pentostatin, and Cyclophosphamide in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT NCT01024010)
NCT ID: NCT01024010
Last Updated: 2018-09-18
Results Overview
In Arm A: PCO, the primary endpoint of this trial is the percentage of complete responses. The NCI Working Group criteria was used to assess response to therapy: A Complete Response (CR) is briefly defines as the absence of lymphadenopathy, no heptomegaly nor splenomegaly, neutrophils greater than 1500/ul, platelets \> 100,000/ul, hemoglobin \>11.0 gm/dl, and peripheral blood lymphocytes \<4000uL.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
82 participants
Primary outcome timeframe
7 months
Results posted on
2018-09-18
Participant Flow
Participant milestones
| Measure |
Arm A: PCO
Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.
During cycles 1-6, patients also receive 2 mg/m\^2 pentostatin IV over 30 minutes on day 1, 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2.
|
Arm B: PCO +O
Patients receive 300 mg ofatumumab IV on day 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.
During cycles1-6, patients also receive 2 mg/m\^2 pentostatin IV over 30 minutes on day 1, 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2.
For cycles 7-12, patients receive 1000 mg ofatumumab IV on day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
34
|
|
Overall Study
COMPLETED
|
48
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ofatumumab, Pentostatin, and Cyclophosphamide in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Baseline characteristics by cohort
| Measure |
Arm A: PCO
n=48 Participants
Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.
During cycles 1-6, patients also receive 2 mg/m\^2 pentostatin IV over 30 minutes on day 1, 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2.
|
Arm B: PCO +O
n=34 Participants
Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.
During cycles1-6, patients also receive 2 mg/m\^2 pentostatin IV over 30 minutes on day 1, 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2.
For cycles 7-12, patients receive 1000 mg ofatumumab IV on day 1.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=93 Participants
|
59 years
n=4 Participants
|
63 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=93 Participants
|
34 participants
n=4 Participants
|
82 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 7 monthsPopulation: All patients that began Arm A protocol treatment were included in this analysis.
In Arm A: PCO, the primary endpoint of this trial is the percentage of complete responses. The NCI Working Group criteria was used to assess response to therapy: A Complete Response (CR) is briefly defines as the absence of lymphadenopathy, no heptomegaly nor splenomegaly, neutrophils greater than 1500/ul, platelets \> 100,000/ul, hemoglobin \>11.0 gm/dl, and peripheral blood lymphocytes \<4000uL.
Outcome measures
| Measure |
Arm A: PCO
n=48 Participants
Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.
During cycles 1-6, patients also receive 2 mg/m\^2 pentostatin IV over 30 minutes on day 1, 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2.
|
Arm B: PCO +O
Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.
During cycles1-6, patients also receive 2 mg/m\^2 pentostatin IV over 30 minutes on day 1, 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2.
For cycles 7-12, patients receive 1000 mg ofatumumab IV on day 1.
|
|---|---|---|
|
Arm A: Percentage of Complete Responses
|
46 percentage of participants
Interval 31.0 to 61.0
|
—
|
PRIMARY outcome
Timeframe: 18 monthsThe primary endpoint Arm B: PCO+O is treatment-free survival rate at 18 months. An event for treatment-free survival will be defined as initiation of subsequent therapy for CLL or death due to any cause. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for event-free survival at 18 months. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.
Outcome measures
| Measure |
Arm A: PCO
n=48 Participants
Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.
During cycles 1-6, patients also receive 2 mg/m\^2 pentostatin IV over 30 minutes on day 1, 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2.
|
Arm B: PCO +O
n=34 Participants
Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.
During cycles1-6, patients also receive 2 mg/m\^2 pentostatin IV over 30 minutes on day 1, 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2.
For cycles 7-12, patients receive 1000 mg ofatumumab IV on day 1.
|
|---|---|---|
|
Arm B: Treatment-free Survival at 18 Months
|
87.5 percentage of participants
Interval 74.3 to 94.2
|
94.1 percentage of participants
Interval 78.5 to 98.5
|
SECONDARY outcome
Timeframe: 14 monthsPopulation: All patients were evaluable for this endpoint.
The overall response rate will be estimated by the total number of complete or partial responses (CCR, CR, CRi, nPR, or PR) divided by the total number of evaluable patients. Responses will be evaluated using NCI Working Group criteria. Minimum requirements for a Partial Response (PR) requires: * 50% decrease in peripheral blood lymphocyte count from the baseline * 50% reduction in the sum of the products of the largest measured node or nodal masses on physical examination. * 50% reduction in size of liver and/or spleen * 50% improvement in neutrophils, platelets and hemoglobin
Outcome measures
| Measure |
Arm A: PCO
n=48 Participants
Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.
During cycles 1-6, patients also receive 2 mg/m\^2 pentostatin IV over 30 minutes on day 1, 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2.
|
Arm B: PCO +O
n=34 Participants
Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.
During cycles1-6, patients also receive 2 mg/m\^2 pentostatin IV over 30 minutes on day 1, 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2.
For cycles 7-12, patients receive 1000 mg ofatumumab IV on day 1.
|
|---|---|---|
|
Overall Response Rate
|
96 percentage of participants
Interval 86.0 to 99.0
|
97 percentage of participants
Interval 85.0 to 100.0
|
SECONDARY outcome
Timeframe: 14 monthsPopulation: Thirty-one out of the 34 patients registered to Arm B: PCO+O began consolidation, 28 were evaluated for response at the end of consolidation treatment (3 patients did not return for response evaluation at the end of treatment).
The proportion of patients with an improvement in depth of response with the addition of ofatumumab consolidation after PCO induction will be estimated by the number of patients with improvement in response from the time of response evaluation at the completion of PCO to the time of response evaluation at the completion of ofatumumab consolidation divided by the total number of evaluable patients. The hierarchy for depth of response will be in the following increasing order: SD, PR, nPR, CR/CRi with MRD+, CR/CRi with MRD-. An improvement in depth of response will be defined as an improvement of at least one level in the hierarchy. Exact binomial 95% confidence intervals for the true overall improvement rate will be calculated.
Outcome measures
| Measure |
Arm A: PCO
Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.
During cycles 1-6, patients also receive 2 mg/m\^2 pentostatin IV over 30 minutes on day 1, 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2.
|
Arm B: PCO +O
n=28 Participants
Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.
During cycles1-6, patients also receive 2 mg/m\^2 pentostatin IV over 30 minutes on day 1, 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2.
For cycles 7-12, patients receive 1000 mg ofatumumab IV on day 1.
|
|---|---|---|
|
Depth of Response After Ofatumumab Consolidation
|
—
|
25 percentage of participants
Interval 11.0 to 45.0
|
SECONDARY outcome
Timeframe: up to 5 years from registrationTreatment-free survial is defined as the time from registration to the date of initiation of subsequent treatment for CLL or death due to any cause. The distribution of treatment-free survival will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Arm A: PCO
n=48 Participants
Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.
During cycles 1-6, patients also receive 2 mg/m\^2 pentostatin IV over 30 minutes on day 1, 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2.
|
Arm B: PCO +O
n=34 Participants
Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.
During cycles1-6, patients also receive 2 mg/m\^2 pentostatin IV over 30 minutes on day 1, 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2.
For cycles 7-12, patients receive 1000 mg ofatumumab IV on day 1.
|
|---|---|---|
|
Treatment-free Survival
|
56.6 months
Interval 50.16 to
There have not been a sufficient number of events to calculate the upper 95% confidence limit.
|
NA months
Interval 33.8 to
There have not been a sufficient number of events to calculate the median and upper 95% confidence limit.
|
Adverse Events
Arm A: PCO
Serious events: 10 serious events
Other events: 48 other events
Deaths: 0 deaths
Arm B: PCO +O
Serious events: 6 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: PCO
n=48 participants at risk
Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.
During cycles 1-6, patients also receive 2 mg/m\^2 pentostatin IV over 30 minutes on day 1, 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2.
|
Arm B: PCO +O
n=34 participants at risk
Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.
During cycles1-6, patients also receive 2 mg/m\^2 pentostatin IV over 30 minutes on day 1, 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2.
For cycles 7-12, patients receive 1000 mg ofatumumab IV on day 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Blood and lymphatic system disorders
Hemolysis
|
4.2%
2/48 • Number of events 2
|
0.00%
0/34
|
|
Cardiac disorders
Mobitz (type) II atrioventricular block
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
1/48 • Number of events 2
|
0.00%
0/34
|
|
Gastrointestinal disorders
Nausea
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
General disorders
Death NOS
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
General disorders
Fatigue
|
2.1%
1/48 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/48
|
2.9%
1/34 • Number of events 1
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/48
|
2.9%
1/34 • Number of events 1
|
|
Infections and infestations
Infections and infestations - Other, specify
|
4.2%
2/48 • Number of events 2
|
0.00%
0/34
|
|
Infections and infestations
Lung infection
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Infections and infestations
Sepsis
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Infections and infestations
Skin infection
|
0.00%
0/48
|
2.9%
1/34 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Investigations
Platelet count decreased
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Investigations
White blood cell decreased
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/48
|
2.9%
1/34 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/48
|
2.9%
1/34 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Nervous system disorders
Headache
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Nervous system disorders
Syncope
|
0.00%
0/48
|
2.9%
1/34 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/48
|
2.9%
1/34 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Vascular disorders
Hypotension
|
0.00%
0/48
|
2.9%
1/34 • Number of events 1
|
Other adverse events
| Measure |
Arm A: PCO
n=48 participants at risk
Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.
During cycles 1-6, patients also receive 2 mg/m\^2 pentostatin IV over 30 minutes on day 1, 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2.
|
Arm B: PCO +O
n=34 participants at risk
Patients receive 300 mg ofatumumab IV on days 1, cycle 1 and 1000 mg ofatumumab IV on day 2 of cycle 1 and on day 1 of cycles 2-6.
During cycles1-6, patients also receive 2 mg/m\^2 pentostatin IV over 30 minutes on day 1, 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1, and 6 mg pegfilgrastim subcutaneously on day 2.
For cycles 7-12, patients receive 1000 mg ofatumumab IV on day 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
83.3%
40/48 • Number of events 179
|
94.1%
32/34 • Number of events 183
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/48
|
5.9%
2/34 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/48
|
2.9%
1/34 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/48
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
Bloating
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Gastrointestinal disorders
Constipation
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Gastrointestinal disorders
Diarrhea
|
2.1%
1/48 • Number of events 1
|
2.9%
1/34 • Number of events 2
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Gastrointestinal disorders
Nausea
|
37.5%
18/48 • Number of events 29
|
14.7%
5/34 • Number of events 10
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
6/48 • Number of events 10
|
5.9%
2/34 • Number of events 6
|
|
General disorders
Chills
|
6.2%
3/48 • Number of events 4
|
2.9%
1/34 • Number of events 1
|
|
General disorders
Fatigue
|
27.1%
13/48 • Number of events 25
|
17.6%
6/34 • Number of events 13
|
|
General disorders
Fever
|
27.1%
13/48 • Number of events 16
|
35.3%
12/34 • Number of events 15
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
General disorders
Infusion related reaction
|
2.1%
1/48 • Number of events 1
|
8.8%
3/34 • Number of events 3
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/48
|
8.8%
3/34 • Number of events 7
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/48
|
2.9%
1/34 • Number of events 2
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/48
|
5.9%
2/34 • Number of events 2
|
|
Infections and infestations
Lung infection
|
14.6%
7/48 • Number of events 9
|
23.5%
8/34 • Number of events 12
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/48
|
2.9%
1/34 • Number of events 1
|
|
Infections and infestations
Peripheral nerve infection
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Infections and infestations
Sepsis
|
0.00%
0/48
|
2.9%
1/34 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
2.1%
1/48 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
Infections and infestations
Skin infection
|
4.2%
2/48 • Number of events 2
|
5.9%
2/34 • Number of events 2
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
16/48 • Number of events 23
|
55.9%
19/34 • Number of events 40
|
|
Infections and infestations
Urinary tract infection
|
4.2%
2/48 • Number of events 2
|
0.00%
0/34
|
|
Investigations
Alanine aminotransferase increased
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Investigations
Creatinine increased
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Investigations
INR increased
|
0.00%
0/48
|
2.9%
1/34 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/48
|
52.9%
18/34 • Number of events 118
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/48
|
2.9%
1/34 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
47.9%
23/48 • Number of events 55
|
76.5%
26/34 • Number of events 96
|
|
Investigations
Platelet count decreased
|
68.8%
33/48 • Number of events 205
|
88.2%
30/34 • Number of events 248
|
|
Investigations
Weight loss
|
4.2%
2/48 • Number of events 2
|
0.00%
0/34
|
|
Investigations
White blood cell decreased
|
56.2%
27/48 • Number of events 70
|
82.4%
28/34 • Number of events 150
|
|
Metabolism and nutrition disorders
Anorexia
|
4.2%
2/48 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/48
|
2.9%
1/34 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
1/48 • Number of events 2
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.2%
2/48 • Number of events 2
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Nervous system disorders
Dysgeusia
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Nervous system disorders
Headache
|
4.2%
2/48 • Number of events 2
|
0.00%
0/34
|
|
Psychiatric disorders
Confusion
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Psychiatric disorders
Depression
|
0.00%
0/48
|
2.9%
1/34 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
4.2%
2/48 • Number of events 2
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
4.2%
2/48 • Number of events 3
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
2/48 • Number of events 2
|
5.9%
2/34 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.2%
2/48 • Number of events 3
|
2.9%
1/34 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/48
|
5.9%
2/34 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/48
|
2.9%
1/34 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
3/48 • Number of events 4
|
2.9%
1/34 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/48
|
2.9%
1/34 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.6%
7/48 • Number of events 8
|
11.8%
4/34 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.4%
5/48 • Number of events 6
|
5.9%
2/34 • Number of events 2
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/48
|
2.9%
1/34 • Number of events 1
|
|
Vascular disorders
Hypertension
|
2.1%
1/48 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
Vascular disorders
Lymphedema
|
2.1%
1/48 • Number of events 1
|
0.00%
0/34
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place