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PCI-32765 for Special Cases of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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ClinicalTrials.gov Identifier: NCT01500733
Recruitment Status : Active, not recruiting
First Posted : December 28, 2011
Results First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Leukemia, Lymphocytyc
CLL (Chronic Lymphocytic Leukemia)
SLL (Small Lymphocytic Lymphoma)
Intervention Drug: PCI 32765
Enrollment 86
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Elderly Cohort TP53 Cohort
Hide Arm/Group Description Chronic lymphocytic leukemia patients 65 years or older Chronic lymphocytic leukemia patients having TP53 aberration, either due to deletion of chromosome 17p or TP53 mutation
Period Title: Overall Study
Started 35 51
Completed 33 48
Not Completed 2 3
Arm/Group Title Elderly Cohort TP53 Cohort Total
Hide Arm/Group Description Chronic lymphocytic leukemia patients 65 years or older Chronic lymphocytic leukemia patients having TP53 aberration, either due to deletion of chromosome 17p or TP53 mutation Total of all reporting groups
Overall Number of Baseline Participants 35 51 86
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 51 participants 86 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
   2.9%
30
  58.8%
31
  36.0%
>=65 years
34
  97.1%
21
  41.2%
55
  64.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 51 participants 86 participants
Female
16
  45.7%
20
  39.2%
36
  41.9%
Male
19
  54.3%
31
  60.8%
50
  58.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 51 participants 86 participants
Hispanic or Latino
0
   0.0%
3
   5.9%
3
   3.5%
Not Hispanic or Latino
35
 100.0%
48
  94.1%
83
  96.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 51 participants 86 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
2
   3.9%
2
   2.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   5.7%
4
   7.8%
6
   7.0%
White
33
  94.3%
44
  86.3%
77
  89.5%
More than one race
0
   0.0%
1
   2.0%
1
   1.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Overall Response Rate at 6 Months
Hide Description

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
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who received ibrutinib, and completed 6 cycles of therapy.
Arm/Group Title Elderly Cohort TP53 Cohort
Hide Arm/Group Description:
Chronic lymphocytic leukemia patients 65 years or older
Chronic lymphocytic leukemia patients having TP53 aberration, either due to deletion of chromosome 17p or TP53 mutation
Overall Number of Participants Analyzed 33 48
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
93.9
(79.8 to 99.3)
95.8
(85.7 to 99.5)
Time Frame 69 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Elderly Cohort TP53 Cohort
Hide Arm/Group Description Chronic lymphocytic leukemia patients 65 years or older Chronic lymphocytic leukemia patients having T53 aberration, either due to deletion of chromosome 17p or TP53 mutation
All-Cause Mortality
Elderly Cohort TP53 Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   5/35 (14.29%)   13/51 (25.49%) 
Show Serious Adverse Events Hide Serious Adverse Events
Elderly Cohort TP53 Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   25/35 (71.43%)   29/51 (56.86%) 
Blood and lymphatic system disorders     
Anemia   2/35 (5.71%)  0/51 (0.00%) 
Cardiac disorders     
Atrial fibrillation   3/35 (8.57%)  4/51 (7.84%) 
Cardiac disorders - Other, specify   1/35 (2.86%)  3/51 (5.88%) 
Chest pain - cardiac   0/35 (0.00%)  1/51 (1.96%) 
Heart failure   1/35 (2.86%)  1/51 (1.96%) 
Stroke   0/35 (0.00%)  1/51 (1.96%) 
Eye disorders     
Retinopathy   0/35 (0.00%)  1/51 (1.96%) 
Gastrointestinal disorders     
Dysphagia   1/35 (2.86%)  0/51 (0.00%) 
Gastric ulcer   1/35 (2.86%)  0/51 (0.00%) 
Lower gastrointestinal hemorrhage   0/35 (0.00%)  1/51 (1.96%) 
General disorders     
Death, NOS   1/35 (2.86%)  0/51 (0.00%) 
Edema limbs   1/35 (2.86%)  0/51 (0.00%) 
Fever   0/35 (0.00%)  2/51 (3.92%) 
General disorders and administration site conditions - Other, specify   1/35 (2.86%)  0/51 (0.00%) 
Immune system disorders     
Immune system disorders - Other, specify   0/35 (0.00%)  1/51 (1.96%) 
Infections and infestations     
Abdominal infection   0/35 (0.00%)  1/51 (1.96%) 
Infections and infestations - Other, specify   5/35 (14.29%)  7/51 (13.73%) 
Lung infection   9/35 (25.71%)  7/51 (13.73%) 
Pleural infection   0/35 (0.00%)  1/51 (1.96%) 
Prostate infection   1/35 (2.86%)  0/51 (0.00%) 
Sepsis   0/35 (0.00%)  3/51 (5.88%) 
Skin infection   1/35 (2.86%)  3/51 (5.88%) 
Upper respiratory infection   1/35 (2.86%)  0/51 (0.00%) 
Injury, poisoning and procedural complications     
Fracture   0/35 (0.00%)  1/51 (1.96%) 
Investigations     
Neutrophil count decreased   0/35 (0.00%)  1/51 (1.96%) 
Metabolism and nutrition disorders     
Hypoglycemia   1/35 (2.86%)  0/51 (0.00%) 
Hyponatremia   1/35 (2.86%)  0/51 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia   0/35 (0.00%)  1/51 (1.96%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify   11/35 (31.43%)  9/51 (17.65%) 
Nervous system disorders     
Amnesia   0/35 (0.00%)  1/51 (1.96%) 
Nervous system disorders - Other, specify   1/35 (2.86%)  0/51 (0.00%) 
Presyncope   0/35 (0.00%)  1/51 (1.96%) 
Syncope   0/35 (0.00%)  1/51 (1.96%) 
Psychiatric disorders     
Delirium   0/35 (0.00%)  1/51 (1.96%) 
Renal and urinary disorders     
Acute kidney injury   0/35 (0.00%)  1/51 (1.96%) 
Hematuria   0/35 (0.00%)  2/51 (3.92%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea   0/35 (0.00%)  1/51 (1.96%) 
Respiratory, thoracic and mediastinal disorders - Other, specify   0/35 (0.00%)  2/51 (3.92%) 
Skin and subcutaneous tissue disorders     
Skin and subcutaneous tissue disorders - Other, specify   1/35 (2.86%)  0/51 (0.00%) 
Surgical and medical procedures     
Surgical and medical procedures - Other, specify   0/35 (0.00%)  1/51 (1.96%) 
Vascular disorders     
Hypotension   0/35 (0.00%)  1/51 (1.96%) 
Vascular disorders - Other, specify   0/35 (0.00%)  1/51 (1.96%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Elderly Cohort TP53 Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   35/35 (100.00%)   51/51 (100.00%) 
Blood and lymphatic system disorders     
Anemia   29/35 (82.86%)  40/51 (78.43%) 
Blood and lymphatic system disorders - Other, specify   0/35 (0.00%)  8/51 (15.69%) 
Leukocytosis   12/35 (34.29%)  20/51 (39.22%) 
Lymph node pain   2/35 (5.71%)  8/51 (15.69%) 
Cardiac disorders     
Atrial fibrillation   7/35 (20.00%)  8/51 (15.69%) 
Atrioventricular block first degree   0/35 (0.00%)  2/51 (3.92%) 
Cardiac disorders - Other, specify   0/35 (0.00%)  3/51 (5.88%) 
Chest pain - cardiac   1/35 (2.86%)  0/51 (0.00%) 
Hypertension   2/35 (5.71%)  0/51 (0.00%) 
Palpitations   7/35 (20.00%)  10/51 (19.61%) 
Pericardial effusion   2/35 (5.71%)  0/51 (0.00%) 
Sinus bradycardia   6/35 (17.14%)  9/51 (17.65%) 
Sinus tachycardia   2/35 (5.71%)  6/51 (11.76%) 
Ear and labyrinth disorders     
Ear and labyrinth disorders - Other, specify   5/35 (14.29%)  2/51 (3.92%) 
Ear pain   1/35 (2.86%)  2/51 (3.92%) 
External ear inflammation   1/35 (2.86%)  0/51 (0.00%) 
Hearing impaired   4/35 (11.43%)  1/51 (1.96%) 
Tinnitus   1/35 (2.86%)  1/51 (1.96%) 
Vertigo   3/35 (8.57%)  1/51 (1.96%) 
Endocrine disorders     
Endocrine disorders - Other, specify   1/35 (2.86%)  3/51 (5.88%) 
Hypothyroidism   1/35 (2.86%)  0/51 (0.00%) 
Eye disorders     
Blurred vision   3/35 (8.57%)  4/51 (7.84%) 
Cataract   5/35 (14.29%)  1/51 (1.96%) 
Conjunctivitis   1/35 (2.86%)  5/51 (9.80%) 
Dry eye   2/35 (5.71%)  5/51 (9.80%) 
Eye disorders - Other, specify   9/35 (25.71%)  14/51 (27.45%) 
Eye pain   1/35 (2.86%)  0/51 (0.00%) 
Floaters   2/35 (5.71%)  1/51 (1.96%) 
Glaucoma   1/35 (2.86%)  1/51 (1.96%) 
Scleral disorder   1/35 (2.86%)  0/51 (0.00%) 
Uveitis   0/35 (0.00%)  2/51 (3.92%) 
Watering eyes   1/35 (2.86%)  0/51 (0.00%) 
Gastrointestinal disorders     
Abdominal distension   1/35 (2.86%)  0/51 (0.00%) 
Abdominal pain   5/35 (14.29%)  7/51 (13.73%) 
Anal fistula   0/35 (0.00%)  1/51 (1.96%) 
Anorexia   1/35 (2.86%)  0/51 (0.00%) 
Ascites   1/35 (2.86%)  0/51 (0.00%) 
Bloating   2/35 (5.71%)  4/51 (7.84%) 
Cheilitis   1/35 (2.86%)  1/51 (1.96%) 
Colitis   2/35 (5.71%)  1/51 (1.96%) 
Constipation   6/35 (17.14%)  3/51 (5.88%) 
Dental caries   1/35 (2.86%)  3/51 (5.88%) 
Diarrhea   25/35 (71.43%)  35/51 (68.63%) 
Dry mouth   4/35 (11.43%)  1/51 (1.96%) 
Dyspepsia   1/35 (2.86%)  1/51 (1.96%) 
Dysphagia   2/35 (5.71%)  4/51 (7.84%) 
Flatulence   2/35 (5.71%)  2/51 (3.92%) 
Gastritis   1/35 (2.86%)  1/51 (1.96%) 
Gastroesophageal reflux disease   7/35 (20.00%)  7/51 (13.73%) 
Gastrointestinal disorders - Other, specify   11/35 (31.43%)  13/51 (25.49%) 
Gastrointestinal pain   1/35 (2.86%)  0/51 (0.00%) 
Hemorrhoidal hemorrhage   0/35 (0.00%)  1/51 (1.96%) 
Hemorrhoids   0/35 (0.00%)  1/51 (1.96%) 
Lower gastrointestinal hemorrhage   0/35 (0.00%)  2/51 (3.92%) 
Mucositis oral   6/35 (17.14%)  12/51 (23.53%) 
Nausea   6/35 (17.14%)  12/51 (23.53%) 
Oral hemorrhage   3/35 (8.57%)  2/51 (3.92%) 
Oral pain   0/35 (0.00%)  1/51 (1.96%) 
Periodontal disease   1/35 (2.86%)  0/51 (0.00%) 
Stomach pain   0/35 (0.00%)  1/51 (1.96%) 
Toothache   0/35 (0.00%)  1/51 (1.96%) 
Vomiting   3/35 (8.57%)  8/51 (15.69%) 
General disorders     
Chills   8/35 (22.86%)  12/51 (23.53%) 
Dizziness   0/35 (0.00%)  2/51 (3.92%) 
Edema face   1/35 (2.86%)  1/51 (1.96%) 
Edema limbs   11/35 (31.43%)  18/51 (35.29%) 
Fatigue   12/35 (34.29%)  23/51 (45.10%) 
Fever   7/35 (20.00%)  16/51 (31.37%) 
Flu like symptoms   3/35 (8.57%)  7/51 (13.73%) 
General disorders and administration site conditions - Other, specify   5/35 (14.29%)  7/51 (13.73%) 
Headache   0/35 (0.00%)  1/51 (1.96%) 
Infusion site extravasation   0/35 (0.00%)  1/51 (1.96%) 
Localized edema   0/35 (0.00%)  2/51 (3.92%) 
Malaise   1/35 (2.86%)  2/51 (3.92%) 
Neck edema   0/35 (0.00%)  2/51 (3.92%) 
Non-cardiac chest pain   3/35 (8.57%)  4/51 (7.84%) 
Pain   15/35 (42.86%)  19/51 (37.25%) 
Weight loss   1/35 (2.86%)  0/51 (0.00%) 
Hepatobiliary disorders     
Hepatobiliary disorders - Other, specify   2/35 (5.71%)  0/51 (0.00%) 
Immune system disorders     
Allergic reaction   1/35 (2.86%)  5/51 (9.80%) 
Infections and infestations     
Anorectal infection   0/35 (0.00%)  1/51 (1.96%) 
Bronchial infection   4/35 (11.43%)  7/51 (13.73%) 
Eye infection   1/35 (2.86%)  2/51 (3.92%) 
Gum infection   1/35 (2.86%)  0/51 (0.00%) 
Infections and infestations - Other, specify   14/35 (40.00%)  29/51 (56.86%) 
Laryngitis   0/35 (0.00%)  1/51 (1.96%) 
Lung infection   8/35 (22.86%)  5/51 (9.80%) 
Nail infection   2/35 (5.71%)  3/51 (5.88%) 
Otitis externa   2/35 (5.71%)  0/51 (0.00%) 
Papulopustular rash   6/35 (17.14%)  4/51 (7.84%) 
Paronychia   1/35 (2.86%)  2/51 (3.92%) 
Pharyngitis   0/35 (0.00%)  1/51 (1.96%) 
Rash pustular   0/35 (0.00%)  1/51 (1.96%) 
Rhinitis infective   1/35 (2.86%)  0/51 (0.00%) 
Sinusitis   14/35 (40.00%)  14/51 (27.45%) 
Skin infection   9/35 (25.71%)  10/51 (19.61%) 
Upper respiratory infection   17/35 (48.57%)  18/51 (35.29%) 
Urinary tract infection   5/35 (14.29%)  7/51 (13.73%) 
Vaginal infection   1/35 (2.86%)  0/51 (0.00%) 
Vulval infection   1/35 (2.86%)  1/51 (1.96%) 
Injury, poisoning and procedural complications     
Bruising   25/35 (71.43%)  34/51 (66.67%) 
Fall   7/35 (20.00%)  9/51 (17.65%) 
Fracture   4/35 (11.43%)  2/51 (3.92%) 
Injury, poisoning and procedural complications - Other, specify   4/35 (11.43%)  8/51 (15.69%) 
Intraoperative skin injury   1/35 (2.86%)  0/51 (0.00%) 
Investigations     
Activated partial thromboplastin time prolonged   4/35 (11.43%)  5/51 (9.80%) 
Alanine aminotransferase increased   12/35 (34.29%)  22/51 (43.14%) 
Alkaline phosphatase increased   10/35 (28.57%)  12/51 (23.53%) 
Aspartate aminotransferase increased   13/35 (37.14%)  15/51 (29.41%) 
Blood bilirubin increased   9/35 (25.71%)  18/51 (35.29%) 
Cardiac troponin I increased   0/35 (0.00%)  1/51 (1.96%) 
CPK increased   5/35 (14.29%)  6/51 (11.76%) 
Creatinine increased   17/35 (48.57%)  28/51 (54.90%) 
Electrocardiogram QT corrected interval prolonged   0/35 (0.00%)  3/51 (5.88%) 
Haptoglobin decreased   3/35 (8.57%)  4/51 (7.84%) 
Hypercalcemia   1/35 (2.86%)  0/51 (0.00%) 
Hypermagnesemia   0/35 (0.00%)  1/51 (1.96%) 
Hypernatremia   0/35 (0.00%)  1/51 (1.96%) 
Hypoalbuminemia   0/35 (0.00%)  1/51 (1.96%) 
Hyponatremia   1/35 (2.86%)  0/51 (0.00%) 
INR increased   4/35 (11.43%)  2/51 (3.92%) 
Investigations - Other, specify   8/35 (22.86%)  5/51 (9.80%) 
Lipase increased   0/35 (0.00%)  2/51 (3.92%) 
Lymphocyte count decreased   15/35 (42.86%)  19/51 (37.25%) 
Lymphocyte count increased   32/35 (91.43%)  48/51 (94.12%) 
Neutrophil count decreased   20/35 (57.14%)  34/51 (66.67%) 
Platelet count decreased   28/35 (80.00%)  38/51 (74.51%) 
Weight gain   17/35 (48.57%)  28/51 (54.90%) 
Weight loss   7/35 (20.00%)  11/51 (21.57%) 
White blood cell decreased   11/35 (31.43%)  11/51 (21.57%) 
Metabolism and nutrition disorders     
Alkalosis   0/35 (0.00%)  1/51 (1.96%) 
Anorexia   10/35 (28.57%)  8/51 (15.69%) 
Dehydration   2/35 (5.71%)  3/51 (5.88%) 
Hypercalcemia   2/35 (5.71%)  0/51 (0.00%) 
Hyperglycemia   5/35 (14.29%)  10/51 (19.61%) 
Hyperkalemia   7/35 (20.00%)  5/51 (9.80%) 
Hypermagnesemia   5/35 (14.29%)  7/51 (13.73%) 
Hypernatremia   15/35 (42.86%)  17/51 (33.33%) 
Hyperuricemia   15/35 (42.86%)  15/51 (29.41%) 
Hypoalbuminemia   23/35 (65.71%)  26/51 (50.98%) 
Hypocalcemia   17/35 (48.57%)  23/51 (45.10%) 
Hypoglycemia   1/35 (2.86%)  1/51 (1.96%) 
Hypokalemia   6/35 (17.14%)  7/51 (13.73%) 
Hypomagnesemia   3/35 (8.57%)  6/51 (11.76%) 
Hyponatremia   8/35 (22.86%)  10/51 (19.61%) 
Hypophosphatemia   9/35 (25.71%)  13/51 (25.49%) 
Metabolism and nutrition disorders - Other, specify   0/35 (0.00%)  2/51 (3.92%) 
Obesity   5/35 (14.29%)  8/51 (15.69%) 
Musculoskeletal and connective tissue disorders     
Arthralgia   16/35 (45.71%)  23/51 (45.10%) 
Arthritis   11/35 (31.43%)  6/51 (11.76%) 
Back pain   8/35 (22.86%)  8/51 (15.69%) 
Bone pain   3/35 (8.57%)  2/51 (3.92%) 
Flank pain   3/35 (8.57%)  1/51 (1.96%) 
Generalized muscle weakness   0/35 (0.00%)  2/51 (3.92%) 
Joint range of motion decreased   0/35 (0.00%)  1/51 (1.96%) 
Muscle weakness lower limb   0/35 (0.00%)  1/51 (1.96%) 
Muscle weakness upper limb   0/35 (0.00%)  1/51 (1.96%) 
Musculoskeletal and connective tissue disorder - Other, specify   4/35 (11.43%)  10/51 (19.61%) 
Musculoskeletal deformity   1/35 (2.86%)  0/51 (0.00%) 
Myalgia   15/35 (42.86%)  19/51 (37.25%) 
Neck pain   4/35 (11.43%)  4/51 (7.84%) 
Osteoporosis   0/35 (0.00%)  2/51 (3.92%) 
Pain in extremity   5/35 (14.29%)  20/51 (39.22%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify   11/35 (31.43%)  8/51 (15.69%) 
Nervous system disorders     
Amnesia   1/35 (2.86%)  1/51 (1.96%) 
Dizziness   3/35 (8.57%)  16/51 (31.37%) 
Dysarthria   0/35 (0.00%)  1/51 (1.96%) 
Dysgeusia   0/35 (0.00%)  1/51 (1.96%) 
Headache   6/35 (17.14%)  10/51 (19.61%) 
Lethargy   0/35 (0.00%)  1/51 (1.96%) 
Memory impairment   1/35 (2.86%)  3/51 (5.88%) 
Nervous system disorders - Other, specify   2/35 (5.71%)  3/51 (5.88%) 
Neuralgia   1/35 (2.86%)  1/51 (1.96%) 
Paresthesia   4/35 (11.43%)  3/51 (5.88%) 
Peripheral motor neuropathy   1/35 (2.86%)  0/51 (0.00%) 
Peripheral sensory neuropathy   3/35 (8.57%)  3/51 (5.88%) 
Presyncope   0/35 (0.00%)  1/51 (1.96%) 
Seizure   0/35 (0.00%)  1/51 (1.96%) 
Sinus pain   1/35 (2.86%)  0/51 (0.00%) 
Syncope   0/35 (0.00%)  1/51 (1.96%) 
Transient ischemic attacks   0/35 (0.00%)  1/51 (1.96%) 
Tremor   2/35 (5.71%)  1/51 (1.96%) 
Vasovagal reaction   0/35 (0.00%)  2/51 (3.92%) 
Psychiatric disorders     
Anxiety   0/35 (0.00%)  3/51 (5.88%) 
Confusion   1/35 (2.86%)  1/51 (1.96%) 
Depression   0/35 (0.00%)  1/51 (1.96%) 
Insomnia   4/35 (11.43%)  3/51 (5.88%) 
Psychiatric disorders - Other, specify   0/35 (0.00%)  1/51 (1.96%) 
Renal and urinary disorders     
Acute kidney injury   1/35 (2.86%)  1/51 (1.96%) 
Bladder spasm   0/35 (0.00%)  1/51 (1.96%) 
Chronic kidney disease   1/35 (2.86%)  0/51 (0.00%) 
Hematuria   6/35 (17.14%)  10/51 (19.61%) 
Hemoglobinuria   1/35 (2.86%)  4/51 (7.84%) 
Proteinuria   2/35 (5.71%)  2/51 (3.92%) 
Renal and urinary disorders - Other, specify   4/35 (11.43%)  5/51 (9.80%) 
Renal colic   1/35 (2.86%)  0/51 (0.00%) 
Urinary frequency   2/35 (5.71%)  3/51 (5.88%) 
Urinary incontinence   0/35 (0.00%)  1/51 (1.96%) 
Urinary retention   1/35 (2.86%)  0/51 (0.00%) 
Urine discoloration   0/35 (0.00%)  1/51 (1.96%) 
Reproductive system and breast disorders     
Ejaculation disorder   1/35 (2.86%)  1/51 (1.96%) 
Erectile dysfunction   1/35 (2.86%)  0/51 (0.00%) 
Perineal pain   0/35 (0.00%)  1/51 (1.96%) 
Reproductive system and breast disorders - Other, specify   2/35 (5.71%)  1/51 (1.96%) 
Vaginal pain   0/35 (0.00%)  1/51 (1.96%) 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis   2/35 (5.71%)  4/51 (7.84%) 
Atelectasis   0/35 (0.00%)  2/51 (3.92%) 
Cough   15/35 (42.86%)  19/51 (37.25%) 
Dyspnea   10/35 (28.57%)  20/51 (39.22%) 
Epistaxis   5/35 (14.29%)  10/51 (19.61%) 
Hoarseness   2/35 (5.71%)  2/51 (3.92%) 
Hypoxia   3/35 (8.57%)  3/51 (5.88%) 
Laryngeal hemorrhage   1/35 (2.86%)  0/51 (0.00%) 
Nasal congestion   10/35 (28.57%)  11/51 (21.57%) 
Pleural effusion   2/35 (5.71%)  2/51 (3.92%) 
Pneumonitis   2/35 (5.71%)  3/51 (5.88%) 
Pneumothorax   0/35 (0.00%)  2/51 (3.92%) 
Postnasal drip   7/35 (20.00%)  7/51 (13.73%) 
Productive cough   10/35 (28.57%)  10/51 (19.61%) 
Pulmonary fibrosis   1/35 (2.86%)  0/51 (0.00%) 
Respiratory failure   1/35 (2.86%)  0/51 (0.00%) 
Respiratory, thoracic and mediastinal disorders - Other, specify   6/35 (17.14%)  7/51 (13.73%) 
Sleep apnea   3/35 (8.57%)  0/51 (0.00%) 
Sneezing   0/35 (0.00%)  1/51 (1.96%) 
Sore throat   13/35 (37.14%)  11/51 (21.57%) 
Voice alteration   1/35 (2.86%)  0/51 (0.00%) 
Wheezing   1/35 (2.86%)  1/51 (1.96%) 
Skin and subcutaneous tissue disorders     
Alopecia   3/35 (8.57%)  2/51 (3.92%) 
Bullous dermatitis   1/35 (2.86%)  0/51 (0.00%) 
Dry skin   3/35 (8.57%)  4/51 (7.84%) 
Erythema multiforme   1/35 (2.86%)  5/51 (9.80%) 
Nail discoloration   1/35 (2.86%)  3/51 (5.88%) 
Nail loss   0/35 (0.00%)  1/51 (1.96%) 
Nail ridging   2/35 (5.71%)  6/51 (11.76%) 
Palmar-plantar erythrodysesthesia syndrome   0/35 (0.00%)  1/51 (1.96%) 
Pruritus   6/35 (17.14%)  5/51 (9.80%) 
Purpura   5/35 (14.29%)  4/51 (7.84%) 
Rash acneiform   3/35 (8.57%)  4/51 (7.84%) 
Rash maculo-papular   18/35 (51.43%)  25/51 (49.02%) 
Scalp pain   1/35 (2.86%)  0/51 (0.00%) 
Skin and subcutaneous tissue disorders - Other, specify   27/35 (77.14%)  40/51 (78.43%) 
Skin hyperpigmentation   1/35 (2.86%)  4/51 (7.84%) 
Skin hypopigmentation   0/35 (0.00%)  1/51 (1.96%) 
Skin ulceration   5/35 (14.29%)  0/51 (0.00%) 
Urticaria   2/35 (5.71%)  0/51 (0.00%) 
Surgical and medical procedures     
Surgical and medical procedures - Other, specify   11/35 (31.43%)  2/51 (3.92%) 
Vascular disorders     
Hematoma   3/35 (8.57%)  2/51 (3.92%) 
Hot flashes   1/35 (2.86%)  7/51 (13.73%) 
Hypertension   12/35 (34.29%)  23/51 (45.10%) 
Hypotension   1/35 (2.86%)  2/51 (3.92%) 
Lymphedema   0/35 (0.00%)  1/51 (1.96%) 
Phlebitis   0/35 (0.00%)  2/51 (3.92%) 
Thromboembolic event   0/35 (0.00%)  1/51 (1.96%) 
Vascular disorders - Other, specify   0/35 (0.00%)  2/51 (3.92%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Ahn, Inhye
Organization: National Heart Lung and Blood Institute
Phone: +1 301 827 1203
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT01500733     History of Changes
Other Study ID Numbers: 120035
12-H-0035
First Submitted: December 22, 2011
First Posted: December 28, 2011
Results First Submitted: May 10, 2018
Results First Posted: July 11, 2018
Last Update Posted: July 11, 2018