Trial Outcomes & Findings for Ibrutinib, Fludarabine, and Pembrolizumab in High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (NCT NCT03204188)
NCT ID: NCT03204188
Last Updated: 2026-01-30
Results Overview
Rate of complete response with combination ibrutinib, fludarabine, and pembrolizumab in patients with high-risk and/or relapsed/refractory chronic lymphocytic leukemia and small lymphocytic leukemia. Response assessments defined by IWCLL 2008 guidelines incorporating the 2012 and 2013 clarifications for patients treated with kinase inhibitors. Complete response defined as: Lymphadenopathy is none \> 1.5 cm; No Splenomegaly or Hepatomegaly; Blood Lymphocytes \<4000/uL; Bone Marrow is normocellular, \<30% lymphocytes, no B-lymphoid nodules; Platelet count \>100,000/uL; Hemoglobin \> 11.0 g/dL and Neutrophils \>1500/uL. Partial response is defined by meeting 2 criteria: Lymphadenopathy decrease \> or = 50%; Splenomegaly or Hepatomegaly decrease \> or = 50%; Blood Lymphocytes decrease \> or = 50% from baseline; Platelet is \> 100,000/uL or increase \> or = 50% over baseline; Hemoglobin is \> 11.0 g/dL or increase \> or = 50% over baseline; Neutrophils is \> 1500/uL or increase \> or = 50% over baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
1 year
Results posted on
2026-01-30
Participant Flow
Participant milestones
| Measure |
Ibrutinib, Fludarabine, and Pembrolizumab in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Ibrutinib, Fludarabine, and Pembrolizumab combination therapy will be administered in participants with High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL). Ibrutinib will be administered daily by mouth starting cycle -3 at 420 mg until end study or disease progression or intolerable side effects occur. Fludarabine will be administered intravenously only on cycle -2 at 25mg/m\^2 x5 days. Pembrolizumab will be administered intravenously every 3 weeks at 200 mg starting from cycle 1 through cycle 17 or 1 year of immunotherapy phase.
|
|---|---|
|
Conditioning Phase (12 Weeks)
STARTED
|
15
|
|
Conditioning Phase (12 Weeks)
COMPLETED
|
15
|
|
Conditioning Phase (12 Weeks)
NOT COMPLETED
|
0
|
|
Immunotherapy Phase (1 Year)
STARTED
|
15
|
|
Immunotherapy Phase (1 Year)
COMPLETED
|
10
|
|
Immunotherapy Phase (1 Year)
NOT COMPLETED
|
5
|
|
Follow-up Phase (Extension Study)
STARTED
|
10
|
|
Follow-up Phase (Extension Study)
COMPLETED
|
4
|
|
Follow-up Phase (Extension Study)
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Ibrutinib, Fludarabine, and Pembrolizumab in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Ibrutinib, Fludarabine, and Pembrolizumab combination therapy will be administered in participants with High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL). Ibrutinib will be administered daily by mouth starting cycle -3 at 420 mg until end study or disease progression or intolerable side effects occur. Fludarabine will be administered intravenously only on cycle -2 at 25mg/m\^2 x5 days. Pembrolizumab will be administered intravenously every 3 weeks at 200 mg starting from cycle 1 through cycle 17 or 1 year of immunotherapy phase.
|
|---|---|
|
Immunotherapy Phase (1 Year)
Adverse Event
|
4
|
|
Immunotherapy Phase (1 Year)
Death
|
1
|
|
Follow-up Phase (Extension Study)
Progression of Disease
|
4
|
|
Follow-up Phase (Extension Study)
Adverse Event
|
2
|
Baseline Characteristics
Ibrutinib, Fludarabine, and Pembrolizumab in High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Baseline characteristics by cohort
| Measure |
Ibrutinib, Fludarabine, and Pembrolizumab in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
n=15 Participants
Ibrutinib, Fludarabine, and Pembrolizumab combination therapy will be administered in participants with High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL). Ibrutinib will be administered daily by mouth starting cycle -3 at 420 mg until end study or disease progression or intolerable side effects occur. Fludarabine will be administered intravenously only on cycle -2 at 25mg/m\^2 x5 days. Pembrolizumab will be administered intravenously every 3 weeks at 200 mg starting from cycle 1 through cycle 17 or 1 year of immunotherapy phase.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Includes all participants that completed the 1 year evaluation
Rate of complete response with combination ibrutinib, fludarabine, and pembrolizumab in patients with high-risk and/or relapsed/refractory chronic lymphocytic leukemia and small lymphocytic leukemia. Response assessments defined by IWCLL 2008 guidelines incorporating the 2012 and 2013 clarifications for patients treated with kinase inhibitors. Complete response defined as: Lymphadenopathy is none \> 1.5 cm; No Splenomegaly or Hepatomegaly; Blood Lymphocytes \<4000/uL; Bone Marrow is normocellular, \<30% lymphocytes, no B-lymphoid nodules; Platelet count \>100,000/uL; Hemoglobin \> 11.0 g/dL and Neutrophils \>1500/uL. Partial response is defined by meeting 2 criteria: Lymphadenopathy decrease \> or = 50%; Splenomegaly or Hepatomegaly decrease \> or = 50%; Blood Lymphocytes decrease \> or = 50% from baseline; Platelet is \> 100,000/uL or increase \> or = 50% over baseline; Hemoglobin is \> 11.0 g/dL or increase \> or = 50% over baseline; Neutrophils is \> 1500/uL or increase \> or = 50% over baseline.
Outcome measures
| Measure |
Ibrutinib, Fludarabine, and Pembrolizumab in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
n=10 Participants
Ibrutinib, Fludarabine, and Pembrolizumab combination therapy will be administered in participants with High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL). Ibrutinib will be administered daily by mouth starting cycle -3 at 420 mg until end study or disease progression or intolerable side effects occur. Fludarabine will be administered intravenously only on cycle -2 at 25mg/m\^2 x5 days. Pembrolizumab will be administered intravenously every 3 weeks at 200 mg starting from cycle 1 through cycle 17 or 1 year of immunotherapy phase.
|
|---|---|
|
Number of Participants With Complete Response of the Combination of Ibrutinib, Fludarabine, and Pembrolizumab in Patients With High-risk and/or Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Leukemia
Complete Response
|
1 Participants
|
|
Number of Participants With Complete Response of the Combination of Ibrutinib, Fludarabine, and Pembrolizumab in Patients With High-risk and/or Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Leukemia
Partial Response
|
9 Participants
|
SECONDARY outcome
Timeframe: 2 yearsTolerability of the combination regimen, Overall response rate (ORR), Duration of response (DOR), Best response, Minimal residual disease (MRD) status, Progression-free survival (PFS), Overall survival (OS), To explore the biologic effects on B- and T-cell subsets and function, To identify predictors of clinical response.
Outcome measures
Outcome data not reported
Adverse Events
Ibrutinib, Fludarabine, and Pembrolizumab in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Serious events: 11 serious events
Other events: 15 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Ibrutinib, Fludarabine, and Pembrolizumab in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
n=15 participants at risk
Ibrutinib, Fludarabine, and Pembrolizumab combination therapy will be administered in participants with High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL). Ibrutinib will be administered daily by mouth starting cycle -3 at 420 mg until end study or disease progression or intolerable side effects occur. Fludarabine will be administered intravenously only on cycle -2 at 25mg/m\^2 x5 days. Pembrolizumab will be administered intravenously every 3 weeks at 200 mg starting from cycle 1 through cycle 17 or 1 year of immunotherapy phase.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.7%
1/15 • Number of events 2 • 5 year
|
|
General disorders
Malaise
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
General disorders
Multi-organ failure
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Immune system disorders
Allergic reaction
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Infections and infestations
Appendicitis
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Infections and infestations
Lung infection
|
13.3%
2/15 • Number of events 6 • 5 year
|
|
Infections and infestations
Sepsis
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Infections and infestations
Urinary tract infection
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenocarcinoma
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Renal and urinary disorders
Acute kidney injury
|
13.3%
2/15 • Number of events 4 • 5 year
|
|
Renal and urinary disorders
Kidney infection
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Vascular disorders
Thromboembolic event
|
6.7%
1/15 • Number of events 1 • 5 year
|
Other adverse events
| Measure |
Ibrutinib, Fludarabine, and Pembrolizumab in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
n=15 participants at risk
Ibrutinib, Fludarabine, and Pembrolizumab combination therapy will be administered in participants with High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL). Ibrutinib will be administered daily by mouth starting cycle -3 at 420 mg until end study or disease progression or intolerable side effects occur. Fludarabine will be administered intravenously only on cycle -2 at 25mg/m\^2 x5 days. Pembrolizumab will be administered intravenously every 3 weeks at 200 mg starting from cycle 1 through cycle 17 or 1 year of immunotherapy phase.
|
|---|---|
|
Investigations
Neutrophil count decreased
|
73.3%
11/15 • Number of events 39 • 5 year
|
|
Investigations
Platelet count decreased
|
60.0%
9/15 • Number of events 44 • 5 year
|
|
Investigations
Weight gain
|
80.0%
12/15 • Number of events 20 • 5 year
|
|
Investigations
Weight loss
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Investigations
White blood cell decreased
|
33.3%
5/15 • Number of events 20 • 5 year
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Metabolism and nutrition disorders
Anorexia
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
46.7%
7/15 • Number of events 16 • 5 year
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Metabolism and nutrition disorders
Hypernatremia
|
6.7%
1/15 • Number of events 3 • 5 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.7%
1/15 • Number of events 2 • 5 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
26.7%
4/15 • Number of events 4 • 5 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.0%
3/15 • Number of events 3 • 5 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
5/15 • Number of events 11 • 5 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.0%
3/15 • Number of events 5 • 5 year
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Metabolism and nutrition disorders
Iron deficiency
|
6.7%
1/15 • Number of events 3 • 5 year
|
|
Metabolism and nutrition disorders
Polydipsia
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
13.3%
2/15 • Number of events 3 • 5 year
|
|
Metabolism and nutrition disorders
Obesity
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
66.7%
10/15 • Number of events 22 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
26.7%
4/15 • Number of events 4 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
3/15 • Number of events 3 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Left Shin nodules
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rhematica
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Restless leg syndrome
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Right Maxilla tenderness
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Right Shin nodules
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Right three proximal interphalangeal mild synovitis/tenosynovitis
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Degenerative joint disease of neck
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
46.7%
7/15 • Number of events 8 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
1/15 • Number of events 2 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Pain
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
3/15 • Number of events 3 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angioma and melanocytic nevus
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma of skin
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Left shoulder lipoma
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sessile polyps
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Left maxillary mucous retention cyst or polyp
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Left neck nodule
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Nervous system disorders
Ataxia
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Nervous system disorders
Cognitive disturbance
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Nervous system disorders
Concentration impairment
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Nervous system disorders
Depressed level of consciousness
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Nervous system disorders
Dizziness
|
40.0%
6/15 • Number of events 8 • 5 year
|
|
Nervous system disorders
Headache
|
53.3%
8/15 • Number of events 15 • 5 year
|
|
Nervous system disorders
Memory impairment
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Nervous system disorders
Anisocoria
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Nervous system disorders
Sciatic pain
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Nervous system disorders
Paresthesia
|
20.0%
3/15 • Number of events 3 • 5 year
|
|
Nervous system disorders
Peripheral motor neuropathy
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Nervous system disorders
Presyncope
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Nervous system disorders
Tremor
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Psychiatric disorders
Delirium
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Psychiatric disorders
Depression
|
20.0%
3/15 • Number of events 3 • 5 year
|
|
Psychiatric disorders
Insomnia
|
20.0%
3/15 • Number of events 3 • 5 year
|
|
Psychiatric disorders
Suicidal ideation
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Renal and urinary disorders
Acute kidney injury
|
20.0%
3/15 • Number of events 6 • 5 year
|
|
Renal and urinary disorders
Hematoma
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Renal and urinary disorders
Hematuria
|
26.7%
4/15 • Number of events 6 • 5 year
|
|
Renal and urinary disorders
Proteinuria
|
20.0%
3/15 • Number of events 3 • 5 year
|
|
Renal and urinary disorders
Decreased urine output
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Renal and urinary disorders
Renal lesion
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Renal and urinary disorders
Urinary frequency
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Renal and urinary disorders
Urinary incontinence
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Reproductive system and breast disorders
Testicular swelling (hydrocele)
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
26.7%
4/15 • Number of events 4 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
3/15 • Number of events 6 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
20.0%
3/15 • Number of events 4 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal/ hilar adenopathy developing
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Mosaic attenuation ground-glass pattern in both lungs
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary nodules
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
5/15 • Number of events 5 • 5 year
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
20.0%
3/15 • Number of events 3 • 5 year
|
|
Skin and subcutaneous tissue disorders
Paronychia
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
5/15 • Number of events 5 • 5 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
5/15 • Number of events 7 • 5 year
|
|
Skin and subcutaneous tissue disorders
Abrasion
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Skin and subcutaneous tissue disorders
Basal cell carcinoma
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Brittle nails
|
26.7%
4/15 • Number of events 4 • 5 year
|
|
Skin and subcutaneous tissue disorders
Insect bite
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Laceration
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Laceration on finger
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Lesion
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Mosquito bites
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Multiple skin lesions
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Nodule
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Nodule-insect bite
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Non-healing lesion
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Skin and subcutaneous tissue disorders
Palpable lesion on hand
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Skin lesions
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Facial bleeding (right ala of nose)
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Papule
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
26.7%
4/15 • Number of events 4 • 5 year
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Vascular disorders
Hypertension
|
53.3%
8/15 • Number of events 16 • 5 year
|
|
Vascular disorders
Hypotension
|
33.3%
5/15 • Number of events 5 • 5 year
|
|
Renal and urinary disorders
Prostractic obstruction
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
5/15 • Number of events 6 • 5 year
|
|
Gastrointestinal disorders
Anorexia
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Ascites
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Bloating
|
20.0%
3/15 • Number of events 3 • 5 year
|
|
Gastrointestinal disorders
Cheilitis
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 2 • 5 year
|
|
Gastrointestinal disorders
Dental caries
|
6.7%
1/15 • Number of events 2 • 5 year
|
|
Gastrointestinal disorders
Diarrhea
|
60.0%
9/15 • Number of events 15 • 5 year
|
|
Gastrointestinal disorders
Dry mouth
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Gastrointestinal disorders
Dyspepsia
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Gastrointestinal disorders
Dysphagia
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Gastritis
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
20.0%
3/15 • Number of events 3 • 5 year
|
|
Gastrointestinal disorders
Aphthous ulcers
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Esophageal spasm
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Hiatal hernia
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Hyperactive bowel sounds
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Lower lip macular lesion
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Oral ulcers
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Right inguinal hernia
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Hematochezia
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Early satiety
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Nausea
|
46.7%
7/15 • Number of events 17 • 5 year
|
|
Gastrointestinal disorders
Oral hemorrhage
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Stomach pain
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Toothache
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
5/15 • Number of events 9 • 5 year
|
|
General disorders
Chills
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
General disorders
Edema limbs
|
60.0%
9/15 • Number of events 15 • 5 year
|
|
General disorders
Fatigue
|
66.7%
10/15 • Number of events 11 • 5 year
|
|
General disorders
Fever
|
20.0%
3/15 • Number of events 3 • 5 year
|
|
General disorders
Flu like symptoms
|
53.3%
8/15 • Number of events 9 • 5 year
|
|
General disorders
Gait disturbance
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
General disorders
Cold intolerance
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
General disorders
Rhinorrhea
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
General disorders
Infusion site extravasation
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
General disorders
Localized edema
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
General disorders
Non-cardiac chest pain
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
General disorders
Pain
|
66.7%
10/15 • Number of events 15 • 5 year
|
|
General disorders
Sinus bradycardia
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Hepatobiliary disorders
Gallstones
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Hepatobiliary disorders
Hypocalcemia
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Immune system disorders
Allergic reaction
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Infections and infestations
Anorectal infection
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Infections and infestations
Bronchial infection
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Infections and infestations
COVID-19 infection
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Infections and infestations
COVID-19 positive (Aptima SARS-CoV-2 assay)
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Infections and infestations
COVID-19 positive PCR
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Infections and infestations
HSV-1 positive oral ulcer
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Infections and infestations
Shingles
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Infections and infestations
Lung infection
|
20.0%
3/15 • Number of events 4 • 5 year
|
|
Infections and infestations
Mucosal infection
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Infections and infestations
Nail infection
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Infections and infestations
Platelet count decreased
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Infections and infestations
Sinusitis
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Infections and infestations
Skin infection
|
20.0%
3/15 • Number of events 4 • 5 year
|
|
Infections and infestations
Soft tissue infection
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Infections and infestations
Upper respiratory infection
|
20.0%
3/15 • Number of events 3 • 5 year
|
|
Infections and infestations
Urinary tract infection
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Infections and infestations
Weight gain
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Injury, poisoning and procedural complications
Bruising
|
60.0%
9/15 • Number of events 11 • 5 year
|
|
Injury, poisoning and procedural complications
Burn
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
5/15 • Number of events 8 • 5 year
|
|
Injury, poisoning and procedural complications
Fracture
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Injury, poisoning and procedural complications
Splinter in Right thumb
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
5/15 • Number of events 27 • 5 year
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
5/15 • Number of events 5 • 5 year
|
|
Investigations
Aspartate aminotransferase increased
|
46.7%
7/15 • Number of events 15 • 5 year
|
|
Investigations
Blood bilirubin increased
|
40.0%
6/15 • Number of events 14 • 5 year
|
|
Investigations
CD4 lymphocytes decreased
|
20.0%
3/15 • Number of events 3 • 5 year
|
|
Investigations
CPK increased
|
13.3%
2/15 • Number of events 3 • 5 year
|
|
Investigations
Cardiac troponin T increased
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Creatinine increased
|
33.3%
5/15 • Number of events 7 • 5 year
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
GGT increased
|
6.7%
1/15 • Number of events 4 • 5 year
|
|
Investigations
Haptoglobin decreased
|
6.7%
1/15 • Number of events 2 • 5 year
|
|
Investigations
Hyperglycemia
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Hypophosphatemia
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
INR increased
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Ammonia level elevated
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Amylase decreased
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Blood lactate dehydrogenase decreased
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Blood lactate dehydrogenase increased
|
20.0%
3/15 • Number of events 5 • 5 year
|
|
Investigations
CRP increased
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Investigations
Colonoscopy
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Creatine kinase decreased
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Creatinine decreased
|
6.7%
1/15 • Number of events 2 • 5 year
|
|
Investigations
D-dimer increased
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
HDL decreased
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Hyperphosphatemia
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Hypochloremia
|
13.3%
2/15 • Number of events 4 • 5 year
|
|
Investigations
Hypogammaglobulinemia
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Hypouricemia
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Infarct in the left cerebellar vermis
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Interstitial markings bilateral lungs on CXR
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Iron deficiency
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Iron deficiency anemia
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Lactic acid increase
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Lipase decreased
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Neutrophil count increased
|
53.3%
8/15 • Number of events 19 • 5 year
|
|
Investigations
Nodule in right thyroid gland
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Prostate Specific Antigen (PSA) elevated
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Serum Iron decreased
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
TSH increased
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Urea nitrogen increased
|
20.0%
3/15 • Number of events 3 • 5 year
|
|
Investigations
Urinalysis abnormal
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
White Blood Cell increased
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Investigations
Triiodothyronine decreased
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Lymphocyte count decreased
|
46.7%
7/15 • Number of events 52 • 5 year
|
|
Cardiac disorders
Ventricular tachycardia
|
20.0%
3/15 • Number of events 3 • 5 year
|
|
Ear and labyrinth disorders
Aural fullness in left ear
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Ear and labyrinth disorders
Left ear pressure
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Ear and labyrinth disorders
Ear bleeding
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Ear and labyrinth disorders
Left Mastoid Effusion
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Ear and labyrinth disorders
Right posterior tympanic membrane hemorrhage
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Ear and labyrinth disorders
Ear pain
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Ear and labyrinth disorders
Hearing impaired
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Ear and labyrinth disorders
Vertigo
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Ear and labyrinth disorders
Vestibular disorder
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Endocrine disorders
Triiodothyronine decreased
|
20.0%
3/15 • Number of events 4 • 5 year
|
|
Endocrine disorders
Hyperthyroidism
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Endocrine disorders
Hypothyroidism
|
26.7%
4/15 • Number of events 5 • 5 year
|
|
Eye disorders
Blurred vision
|
33.3%
5/15 • Number of events 5 • 5 year
|
|
Eye disorders
Conjunctivitis
|
20.0%
3/15 • Number of events 5 • 5 year
|
|
Eye disorders
Dry eye
|
13.3%
2/15 • Number of events 2 • 5 year
|
|
Eye disorders
Bilateral posterior ocular capsule scarring
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Eye disorders
Blepharitis
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Eye disorders
Diplopia
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Eye disorders
Dry macular degeneration bilaterally
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Investigations
Lymphocyte count increased
|
40.0%
6/15 • Number of events 8 • 5 year
|
|
Eye disorders
Eye hemorrhage (hyphema, subconjunctival hemorrhage and retinal hemorrhage)
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Eye disorders
Injected conjunctiva
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Eye disorders
Left eye stye
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Eye disorders
Lower eyelid droop
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Eye disorders
Retinal hemorrhage
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Eye disorders
Vision impairment (glasses)
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Eye disorders
Left sided subconjunctival hemorrhage
|
6.7%
1/15 • Number of events 2 • 5 year
|
|
Eye disorders
Retinal detachment
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Blood and lymphatic system disorders
Anemia
|
46.7%
7/15 • Number of events 13 • 5 year
|
|
Blood and lymphatic system disorders
Hepatosplenomegaly
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
6.7%
1/15 • Number of events 2 • 5 year
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
6.7%
1/15 • Number of events 4 • 5 year
|
|
Blood and lymphatic system disorders
Fullness above his left collar bone
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.7%
1/15 • Number of events 2 • 5 year
|
|
Blood and lymphatic system disorders
Lymph node pain
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Cardiac disorders
Atrial fibrillation
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Cardiac disorders
AV nodal disease
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Cardiac disorders
Abnormal R-wave progression, early transition of QRS
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Cardiac disorders
Coronary artery disease
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Cardiac disorders
Non-specific T wave abnormalities
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Cardiac disorders
Premature ventricular complex (PVC)
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Cardiac disorders
Heart murmur
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Cardiac disorders
Premature ventricular contractions
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Cardiac disorders
Myocardial infarction
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Cardiac disorders
Palpitations
|
20.0%
3/15 • Number of events 5 • 5 year
|
|
Cardiac disorders
Pericardial effusion
|
6.7%
1/15 • Number of events 1 • 5 year
|
|
Cardiac disorders
Sinus bradycardia
|
20.0%
3/15 • Number of events 6 • 5 year
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
5/15 • Number of events 6 • 5 year
|
|
Cardiac disorders
Supraventricular tachycardia
|
13.3%
2/15 • Number of events 2 • 5 year
|
Additional Information
Adrian Wiestner, M.D., Ph.D., Principal Investigator
National Institutes of Health (NIH) National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-594-6855
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place