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Trial record 1 of 1 for:    NCT01236391
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Safety and Efficacy of PCI-32765 in Participants With Relapsed/Refractory Mantle Cell Lymphoma (MCL) (PCYC-1104-CA)

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ClinicalTrials.gov Identifier: NCT01236391
Recruitment Status : Completed
First Posted : November 8, 2010
Results First Posted : March 13, 2015
Last Update Posted : August 28, 2015
Sponsor:
Collaborator:
Janssen Pharmaceuticals
Information provided by (Responsible Party):
Pharmacyclics LLC.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Mantle Cell Lymphoma
Intervention Drug: PCI-32765
Enrollment 115
Recruitment Details  
Pre-assignment Details One hundred fifteen subjects were enrolled and 111 subjects received at least 1 dose of ibrutinib and constitute the all treated population and the safety analysis set.
Arm/Group Title PCI-32765
Hide Arm/Group Description Participants received 560 mg daily
Period Title: Overall Study
Started 111 [1]
Completed 95 [2]
Not Completed 16
[1]
Participants who received study treatment
[2]
Participants who were on treatment or discontinued treatment due to disease progression or death
Arm/Group Title PCI-32765
Hide Arm/Group Description PCI-32765: 560 mg daily
Overall Number of Baseline Participants 111
Hide Baseline Analysis Population Description
One hundred fifteen subjects were enrolled and 111 subjects received at least 1 dose of ibrutinib and constitute the all treated population and the safety analysis set.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
<=18 years
0
   0.0%
Between 18 and 65 years
41
  36.9%
>=65 years
70
  63.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 111 participants
67.1  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
Female
26
  23.4%
Male
85
  76.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 111 participants
United States 78
Poland 10
Germany 3
United Kingdom 20
1.Primary Outcome
Title Percentage of Participants Achieving Response
Hide Description The primary endpoint of the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR), according to the revised International Working Group Criteria for non-Hodgkin’s lymphoma (Cheson et al, 2007), as assessed by the investigator. CR is a complete disappearance of all disease, no new lesions, lymph nodes must have regressed and be PET negative, spleen and liver should not be palpable and without nodules, and bone marrow must be negative. PR is a >/= 50% decrease in the sum of the product of diameters of the target lesions, and >/= 50% decrease of splenic and hepatic nodules from baseline, no new lesions and no increase in the size of liver, spleen or non-target lesions.
Time Frame The median follow-up time on study for all treated participants is 15.3 (range 1.9 - 22.3) months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of PCI-32765 and constitute the all treated population
Arm/Group Title PCI-32765
Hide Arm/Group Description:
PCI-32765: 560 mg daily
Overall Number of Participants Analyzed 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants with response
67.6
(58.9 to 76.3)
2.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (AEs)
Hide Description Number of participants who had experienced at least one treatment emergent AE
Time Frame From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PCI-32765
Hide Arm/Group Description:
PCI-32765: 560 mg daily
Overall Number of Participants Analyzed 111
Measure Type: Number
Unit of Measure: participants
111
3.Secondary Outcome
Title PCI-32765 and Its Metabolite (PCI-45227) AUC0-24h After Repeat Dosing of PCI-32765
Hide Description Area under the plasma concentration-time curve using data collected at 0, 1, 2, 4, 6-8, and 24 hours post dose (AUC0-24h)
Time Frame Performed During the First Month of Receiving PCI-32765
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK samples were collected in a subset of participants (n=48) in this trial (n=111). PK parameters reported here reflects those that were PK evaluable from the 48 participants.
Arm/Group Title PCI-32765 - Day 8 PCI-45227 (Metabolite)- Day 8
Hide Arm/Group Description:
PCI-32765: 560 mg daily
PCI-32765: 560 mg daily
Overall Number of Participants Analyzed 43 44
Mean (Standard Deviation)
Unit of Measure: AUC0-24h (ng*h/mL)
953  (705) 1263  (707)
4.Secondary Outcome
Title Mean Change From Baseline to Cycle 5 in EORTC QLQ-C30 Global Health Status Score
Hide Description Mean change from baseline to Cycle 5 in the European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) Global Health Status Score according to EORTC QLQ-C30 Scoring Manual (3rd Edition, 2001). For global health status, positive changes indicated better health status or functioning, and negative changes indicated worsening of health status or functioning. Scale scores range from 0 to 100. A change in 5 to 10 points in either direction represents a small change; 10 to 20 points represents a moderate change and greater than 20 points represents a large change.
Time Frame From Baseline to Cycle 5 (Week 20)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EORTC QLQ-C30
Hide Arm/Group Description:
Participants received PCI-32765 560 mg daily and completed the EORTC QLQ-C30 questionnaire at Pre-Dose and at Cycle 5
Overall Number of Participants Analyzed 69
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.6  (22.4)
Time Frame From first dose of PCI-32765 to within 30 days of last dose
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PCI-32765
Hide Arm/Group Description PCI-32765: 560 mg daily
All-Cause Mortality
PCI-32765
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PCI-32765
Affected / at Risk (%)
Total   62/111 (55.86%) 
Blood and lymphatic system disorders   
Febrile neutropenia * 1  3/111 (2.70%) 
Anaemia * 1  2/111 (1.80%) 
Neutropenia * 1  1/111 (0.90%) 
Pancytopenia * 1  1/111 (0.90%) 
Retroperitoneal lymphadenopathy * 1  1/111 (0.90%) 
Thrombocytopenia * 1  1/111 (0.90%) 
Cardiac disorders   
Atrial fibrillation * 1  5/111 (4.50%) 
Atrial flutter * 1  1/111 (0.90%) 
Cardiac arrest * 1  1/111 (0.90%) 
Cardiac failure * 1  1/111 (0.90%) 
Coronary artery occlusion * 1  1/111 (0.90%) 
Gastrointestinal disorders   
Abdominal pain * 1  3/111 (2.70%) 
Ileus paralytic * 1  2/111 (1.80%) 
Diarrhoea * 1  1/111 (0.90%) 
Ileus * 1  1/111 (0.90%) 
Small intestinal obstruction * 1  1/111 (0.90%) 
General disorders   
Oedema peripheral * 1  3/111 (2.70%) 
Pyrexia * 1  3/111 (2.70%) 
Non-cardiac chest pain * 1  2/111 (1.80%) 
Chills * 1  1/111 (0.90%) 
Device leakage * 1  1/111 (0.90%) 
General physical health deterioration * 1  1/111 (0.90%) 
Infections and infestations   
Pneumonia * 1  6/111 (5.41%) 
Urinary tract infection * 1  4/111 (3.60%) 
Bronchitis * 1  2/111 (1.80%) 
Cellulitis * 1  2/111 (1.80%) 
Sepsis * 1  2/111 (1.80%) 
Anal abscess * 1  1/111 (0.90%) 
Cellulitis orbital * 1  1/111 (0.90%) 
Clostridium difficile colitis * 1  1/111 (0.90%) 
Enterocolitis infectious * 1  1/111 (0.90%) 
Gastroenteritis * 1  1/111 (0.90%) 
Herpes zoster ophthalmic * 1  1/111 (0.90%) 
Lower respiratory tract infection * 1  1/111 (0.90%) 
Pneumocystis jiroveci pneumonia * 1  1/111 (0.90%) 
Pneumonia bacterial * 1  1/111 (0.90%) 
Pneumonia klebsiella * 1  1/111 (0.90%) 
Respiratory tract infection * 1  1/111 (0.90%) 
Staphylococcal bacteraemia * 1  1/111 (0.90%) 
Streptococcal infection * 1  1/111 (0.90%) 
Wound infection * 1  1/111 (0.90%) 
Injury, poisoning and procedural complications   
Subdural haematoma * 1  3/111 (2.70%) 
Spinal compression fracture * 1  2/111 (1.80%) 
Metabolism and nutrition disorders   
Dehydration * 1  2/111 (1.80%) 
Musculoskeletal and connective tissue disorders   
Flank pain * 1  2/111 (1.80%) 
Arthralgia * 1  1/111 (0.90%) 
Groin pain * 1  1/111 (0.90%) 
Neck mass * 1  1/111 (0.90%) 
Osteoarthritis * 1  1/111 (0.90%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Mantle cell lymphoma * 1  8/111 (7.21%) 
Bladder cancer * 1  1/111 (0.90%) 
Malignant pleural effusion * 1  1/111 (0.90%) 
Metastatic neoplasm * 1  1/111 (0.90%) 
Nervous system disorders   
Headache * 1  1/111 (0.90%) 
Transient global amnesia * 1  1/111 (0.90%) 
Psychiatric disorders   
Confusional state * 1  2/111 (1.80%) 
Renal and urinary disorders   
Renal failure acute * 1  3/111 (2.70%) 
Haematuria * 1  2/111 (1.80%) 
Renal failure * 1  1/111 (0.90%) 
Urinary tract obstruction * 1  1/111 (0.90%) 
Reproductive system and breast disorders   
Uterovaginal prolapse * 1  1/111 (0.90%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  2/111 (1.80%) 
Respiratory failure * 1  2/111 (1.80%) 
Chronic obstructive pulmonary disease * 1  1/111 (0.90%) 
Hypoxia * 1  1/111 (0.90%) 
Skin and subcutaneous tissue disorders   
Decubitus ulcer * 1  1/111 (0.90%) 
Vascular disorders   
Hypotension * 1  1/111 (0.90%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PCI-32765
Affected / at Risk (%)
Total   111/111 (100.00%) 
Blood and lymphatic system disorders   
Neutropenia * 1  20/111 (18.02%) 
Thrombocytopenia * 1  20/111 (18.02%) 
Anaemia * 1  14/111 (12.61%) 
Leukopenia * 1  7/111 (6.31%) 
Leukocytosis * 1  3/111 (2.70%) 
Febrile neutropenia * 1  1/111 (0.90%) 
Iron deficiency anaemia * 1  1/111 (0.90%) 
Lymphadenopathy * 1  1/111 (0.90%) 
Lymphocytosis * 1  1/111 (0.90%) 
Lymphopenia * 1  1/111 (0.90%) 
Splenomegaly * 1  1/111 (0.90%) 
Cardiac disorders   
Atrial fibrillation * 1  7/111 (6.31%) 
Sinus tachycardia * 1  5/111 (4.50%) 
Sinus bradycardia * 1  2/111 (1.80%) 
Atrioventricular block first degree * 1  1/111 (0.90%) 
Cardiac failure * 1  1/111 (0.90%) 
Mitral valve incompetence * 1  1/111 (0.90%) 
Myocardial infarction * 1  1/111 (0.90%) 
Palpitations * 1  1/111 (0.90%) 
Supraventricular tachycardia * 1  1/111 (0.90%) 
Torsade de pointes * 1  1/111 (0.90%) 
Ventricular tachycardia * 1  1/111 (0.90%) 
Ear and labyrinth disorders   
Ear pain * 1  2/111 (1.80%) 
Hyperacusis * 1  1/111 (0.90%) 
Hypoacusis * 1  1/111 (0.90%) 
Tinnitus * 1  1/111 (0.90%) 
Vertigo * 1  1/111 (0.90%) 
Endocrine disorders   
Hypothyroidism * 1  2/111 (1.80%) 
Eye disorders   
Lacrimation increased * 1  8/111 (7.21%) 
Cataract * 1  6/111 (5.41%) 
Conjunctivitis * 1  6/111 (5.41%) 
Dry eye * 1  5/111 (4.50%) 
Ocular hyperaemia * 1  2/111 (1.80%) 
Vision blurred * 1  2/111 (1.80%) 
Visual acuity reduced * 1  2/111 (1.80%) 
Vitreous floaters * 1  2/111 (1.80%) 
Conjunctival haemorrhage * 1  1/111 (0.90%) 
Diabetic retinopathy * 1  1/111 (0.90%) 
Eye inflammation * 1  1/111 (0.90%) 
Eyelid ptosis * 1  1/111 (0.90%) 
Periorbital oedema * 1  1/111 (0.90%) 
Photophobia * 1  1/111 (0.90%) 
Retinal detachment * 1  1/111 (0.90%) 
Scleral haemorrhage * 1  1/111 (0.90%) 
Gastrointestinal disorders   
Diarrhoea * 1  55/111 (49.55%) 
Nausea * 1  34/111 (30.63%) 
Constipation * 1  28/111 (25.23%) 
Vomiting * 1  25/111 (22.52%) 
Abdominal pain * 1  17/111 (15.32%) 
Stomatitis * 1  13/111 (11.71%) 
Dyspepsia * 1  12/111 (10.81%) 
Abdominal pain upper * 1  6/111 (5.41%) 
Dry mouth * 1  6/111 (5.41%) 
Flatulence * 1  5/111 (4.50%) 
Gastritis * 1  5/111 (4.50%) 
Abdominal distension * 1  4/111 (3.60%) 
Gastrooesophageal reflux disease * 1  4/111 (3.60%) 
Oral pain * 1  4/111 (3.60%) 
Abdominal discomfort * 1  3/111 (2.70%) 
Dysphagia * 1  3/111 (2.70%) 
Epigastric discomfort * 1  3/111 (2.70%) 
Gingival oedema * 1  2/111 (1.80%) 
Mouth ulceration * 1  2/111 (1.80%) 
Proctalgia * 1  2/111 (1.80%) 
Tongue ulceration * 1  2/111 (1.80%) 
Barrett's oesophagus * 1  1/111 (0.90%) 
Cheilitis * 1  1/111 (0.90%) 
Eructation * 1  1/111 (0.90%) 
Faecal incontinence * 1  1/111 (0.90%) 
Frequent bowel movements * 1  1/111 (0.90%) 
Gastric antral vascular ectasia * 1  1/111 (0.90%) 
Glossodynia * 1  1/111 (0.90%) 
Haematochezia * 1  1/111 (0.90%) 
Haemorrhoids * 1  1/111 (0.90%) 
Irritable bowel syndrome * 1  1/111 (0.90%) 
Lip blister * 1  1/111 (0.90%) 
Lip swelling * 1  1/111 (0.90%) 
Lip ulceration * 1  1/111 (0.90%) 
Lower gastrointestinal haemorrhage * 1  1/111 (0.90%) 
Mouth haemorrhage * 1  1/111 (0.90%) 
Odynophagia * 1  1/111 (0.90%) 
Palatal disorder * 1  1/111 (0.90%) 
Pancreatitis chronic * 1  1/111 (0.90%) 
Periodontal disease * 1  1/111 (0.90%) 
Proctitis * 1  1/111 (0.90%) 
Rectal fissure * 1  1/111 (0.90%) 
Rectal haemorrhage * 1  1/111 (0.90%) 
General disorders   
Fatigue * 1  46/111 (41.44%) 
Oedema peripheral * 1  30/111 (27.03%) 
Pyrexia * 1  18/111 (16.22%) 
Asthenia * 1  12/111 (10.81%) 
Influenza like illness * 1  8/111 (7.21%) 
Chills * 1  6/111 (5.41%) 
Chest pain * 1  4/111 (3.60%) 
Mucosal inflammation * 1  4/111 (3.60%) 
Non-cardiac chest pain * 1  3/111 (2.70%) 
Pain * 1  3/111 (2.70%) 
Local swelling * 1  2/111 (1.80%) 
Axillary pain * 1  1/111 (0.90%) 
Chest discomfort * 1  1/111 (0.90%) 
Crepitations * 1  1/111 (0.90%) 
Device leakage * 1  1/111 (0.90%) 
Feeling abnormal * 1  1/111 (0.90%) 
Generalised oedema * 1  1/111 (0.90%) 
Gravitational oedema * 1  1/111 (0.90%) 
Induration * 1  1/111 (0.90%) 
Injection site erythema * 1  1/111 (0.90%) 
Injection site extravasation * 1  1/111 (0.90%) 
Injection site haematoma * 1  1/111 (0.90%) 
Injection site pain * 1  1/111 (0.90%) 
Injection site reaction * 1  1/111 (0.90%) 
Malaise * 1  1/111 (0.90%) 
Oedema * 1  1/111 (0.90%) 
Performance status decreased * 1  1/111 (0.90%) 
Xerosis * 1  1/111 (0.90%) 
Hepatobiliary disorders   
Hyperbilirubinaemia * 1  2/111 (1.80%) 
Hepatic function abnormal * 1  1/111 (0.90%) 
Immune system disorders   
Seasonal allergy * 1  3/111 (2.70%) 
Hypersensitivity * 1  2/111 (1.80%) 
Allergy to arthropod bite * 1  1/111 (0.90%) 
Drug hypersensitivity * 1  1/111 (0.90%) 
Infections and infestations   
Upper respiratory tract infection * 1  26/111 (23.42%) 
Sinusitis * 1  14/111 (12.61%) 
Urinary tract infection * 1  14/111 (12.61%) 
Pneumonia * 1  10/111 (9.01%) 
Nasopharyngitis * 1  9/111 (8.11%) 
Bronchitis * 1  8/111 (7.21%) 
Cellulitis * 1  8/111 (7.21%) 
Folliculitis * 1  5/111 (4.50%) 
Herpes zoster * 1  5/111 (4.50%) 
Rhinitis * 1  5/111 (4.50%) 
Oral herpes * 1  4/111 (3.60%) 
Skin infection * 1  4/111 (3.60%) 
Clostridium difficile colitis * 1  3/111 (2.70%) 
Gastroenteritis * 1  3/111 (2.70%) 
Lower respiratory tract infection * 1  3/111 (2.70%) 
Paronychia * 1  3/111 (2.70%) 
Staphylococcal infection * 1  3/111 (2.70%) 
Tooth infection * 1  3/111 (2.70%) 
Bacteraemia * 1  2/111 (1.80%) 
Clostridial infection * 1  2/111 (1.80%) 
Diverticulitis * 1  2/111 (1.80%) 
Eye infection * 1  2/111 (1.80%) 
Herpes simplex * 1  2/111 (1.80%) 
Infection * 1  2/111 (1.80%) 
Localised infection * 1  2/111 (1.80%) 
Otitis media * 1  2/111 (1.80%) 
Respiratory tract infection * 1  2/111 (1.80%) 
Viral infection * 1  2/111 (1.80%) 
Wound infection * 1  2/111 (1.80%) 
Bronchiolitis * 1  1/111 (0.90%) 
Citrobacter infection * 1  1/111 (0.90%) 
Conjunctivitis infective * 1  1/111 (0.90%) 
Cryptococcosis * 1  1/111 (0.90%) 
Eye infection bacterial * 1  1/111 (0.90%) 
Gastroenteritis viral * 1  1/111 (0.90%) 
Genital infection fungal * 1  1/111 (0.90%) 
Haemophilus infection * 1  1/111 (0.90%) 
Herpes virus infection * 1  1/111 (0.90%) 
Herpes zoster ophthalmic * 1  1/111 (0.90%) 
Histoplasmosis * 1  1/111 (0.90%) 
Implant site infection * 1  1/111 (0.90%) 
Incision site infection * 1  1/111 (0.90%) 
Influenza * 1  1/111 (0.90%) 
Klebsiella infection * 1  1/111 (0.90%) 
Lip infection * 1  1/111 (0.90%) 
Lower respiratory tract infection bacterial * 1  1/111 (0.90%) 
Nail infection * 1  1/111 (0.90%) 
Onychomycosis * 1  1/111 (0.90%) 
Oral candidiasis * 1  1/111 (0.90%) 
Papilloma viral infection * 1  1/111 (0.90%) 
Pharyngitis streptococcal * 1  1/111 (0.90%) 
Pneumonia bacterial * 1  1/111 (0.90%) 
Rash pustular * 1  1/111 (0.90%) 
Rectal abscess * 1  1/111 (0.90%) 
Streptococcal infection * 1  1/111 (0.90%) 
Tinea pedis * 1  1/111 (0.90%) 
Urinary tract infection pseudomonal * 1  1/111 (0.90%) 
Viral upper respiratory tract infection * 1  1/111 (0.90%) 
Injury, poisoning and procedural complications   
Contusion * 1  19/111 (17.12%) 
Fall * 1  8/111 (7.21%) 
Laceration * 1  3/111 (2.70%) 
Excoriation * 1  2/111 (1.80%) 
Traumatic haematoma * 1  2/111 (1.80%) 
Arthropod bite * 1  1/111 (0.90%) 
Eye injury * 1  1/111 (0.90%) 
Head injury * 1  1/111 (0.90%) 
Ligament sprain * 1  1/111 (0.90%) 
Open wound * 1  1/111 (0.90%) 
Post procedural constipation * 1  1/111 (0.90%) 
Post-traumatic pain * 1  1/111 (0.90%) 
Procedural pain * 1  1/111 (0.90%) 
Skeletal injury * 1  1/111 (0.90%) 
Skin wound * 1  1/111 (0.90%) 
Subdural haematoma * 1  1/111 (0.90%) 
Thermal burn * 1  1/111 (0.90%) 
Urinary retention postoperative * 1  1/111 (0.90%) 
Wound * 1  1/111 (0.90%) 
Investigations   
Blood creatinine increased * 1  6/111 (5.41%) 
Alanine aminotransferase increased * 1  3/111 (2.70%) 
Aspartate aminotransferase increased * 1  3/111 (2.70%) 
Weight decreased * 1  3/111 (2.70%) 
Weight increased * 1  3/111 (2.70%) 
Blood bilirubin increased * 1  2/111 (1.80%) 
Cardiac murmur * 1  2/111 (1.80%) 
Glomerular filtration rate decreased * 1  2/111 (1.80%) 
International normalised ratio increased * 1  2/111 (1.80%) 
Activated partial thromboplastin time prolonged * 1  1/111 (0.90%) 
Aspergillus test positive * 1  1/111 (0.90%) 
Blood alkaline phosphatase increased * 1  1/111 (0.90%) 
Blood bilirubin abnormal * 1  1/111 (0.90%) 
Blood cholesterol increased * 1  1/111 (0.90%) 
Blood immunoglobulin G decreased * 1  1/111 (0.90%) 
Blood iron decreased * 1  1/111 (0.90%) 
Blood phosphorus decreased * 1  1/111 (0.90%) 
Breath sounds abnormal * 1  1/111 (0.90%) 
C-reactive protein increased * 1  1/111 (0.90%) 
Haemophilus test positive * 1  1/111 (0.90%) 
Heart rate irregular * 1  1/111 (0.90%) 
Liver function test abnormal * 1  1/111 (0.90%) 
Macular reflex abnormal * 1  1/111 (0.90%) 
Mean cell volume increased * 1  1/111 (0.90%) 
Platelet count decreased * 1  1/111 (0.90%) 
Urine output decreased * 1  1/111 (0.90%) 
White blood cell count increased * 1  1/111 (0.90%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  24/111 (21.62%) 
Hyperuricaemia * 1  15/111 (13.51%) 
Dehydration * 1  12/111 (10.81%) 
Hypokalaemia * 1  9/111 (8.11%) 
Hyponatraemia * 1  6/111 (5.41%) 
Hyperglycaemia * 1  4/111 (3.60%) 
Hypomagnesaemia * 1  4/111 (3.60%) 
Enzyme abnormality * 1  2/111 (1.80%) 
Hypocalcaemia * 1  2/111 (1.80%) 
Hypoglycaemia * 1  2/111 (1.80%) 
Alcohol intolerance * 1  1/111 (0.90%) 
Fluid overload * 1  1/111 (0.90%) 
Gout * 1  1/111 (0.90%) 
Hypercholesterolaemia * 1  1/111 (0.90%) 
Hyperkalaemia * 1  1/111 (0.90%) 
Hyperphosphataemia * 1  1/111 (0.90%) 
Hypoalbuminaemia * 1  1/111 (0.90%) 
Hypophosphataemia * 1  1/111 (0.90%) 
Musculoskeletal and connective tissue disorders   
Muscle spasms * 1  16/111 (14.41%) 
Back pain * 1  14/111 (12.61%) 
Myalgia * 1  14/111 (12.61%) 
Pain in extremity * 1  12/111 (10.81%) 
Arthralgia * 1  11/111 (9.91%) 
Musculoskeletal pain * 1  6/111 (5.41%) 
Muscular weakness * 1  5/111 (4.50%) 
Flank pain * 1  2/111 (1.80%) 
Groin pain * 1  2/111 (1.80%) 
Joint stiffness * 1  2/111 (1.80%) 
Mobility decreased * 1  2/111 (1.80%) 
Musculoskeletal chest pain * 1  2/111 (1.80%) 
Musculoskeletal stiffness * 1  2/111 (1.80%) 
Neck pain * 1  2/111 (1.80%) 
Bone pain * 1  1/111 (0.90%) 
Intervertebral disc degeneration * 1  1/111 (0.90%) 
Joint contracture * 1  1/111 (0.90%) 
Musculoskeletal discomfort * 1  1/111 (0.90%) 
Myopathy * 1  1/111 (0.90%) 
Osteoporosis * 1  1/111 (0.90%) 
Soft tissue disorder * 1  1/111 (0.90%) 
Synovial cyst * 1  1/111 (0.90%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma * 1  1/111 (0.90%) 
Oral papilloma * 1  1/111 (0.90%) 
Skin cancer * 1  1/111 (0.90%) 
Skin papilloma * 1  1/111 (0.90%) 
Squamous cell carcinoma * 1  1/111 (0.90%) 
Squamous cell carcinoma of skin * 1  1/111 (0.90%) 
Nervous system disorders   
Dizziness * 1  16/111 (14.41%) 
Headache * 1  12/111 (10.81%) 
Peripheral sensory neuropathy * 1  6/111 (5.41%) 
Paraesthesia * 1  4/111 (3.60%) 
Memory impairment * 1  3/111 (2.70%) 
Amnesia * 1  2/111 (1.80%) 
Lethargy * 1  2/111 (1.80%) 
Somnolence * 1  2/111 (1.80%) 
Balance disorder * 1  1/111 (0.90%) 
Dizziness postural * 1  1/111 (0.90%) 
Head discomfort * 1  1/111 (0.90%) 
Hypersomnia * 1  1/111 (0.90%) 
Hypoaesthesia * 1  1/111 (0.90%) 
Migraine * 1  1/111 (0.90%) 
Migraine with aura * 1  1/111 (0.90%) 
Neuralgia * 1  1/111 (0.90%) 
Neuropathy peripheral * 1  1/111 (0.90%) 
Nystagmus * 1  1/111 (0.90%) 
Peroneal nerve palsy * 1  1/111 (0.90%) 
Presyncope * 1  1/111 (0.90%) 
Sciatica * 1  1/111 (0.90%) 
Sensory disturbance * 1  1/111 (0.90%) 
Tension headache * 1  1/111 (0.90%) 
Tremor * 1  1/111 (0.90%) 
Psychiatric disorders   
Insomnia * 1  11/111 (9.91%) 
Anxiety * 1  6/111 (5.41%) 
Depression * 1  6/111 (5.41%) 
Agitation * 1  3/111 (2.70%) 
Confusional state * 1  3/111 (2.70%) 
Abnormal behaviour * 1  1/111 (0.90%) 
Euphoric mood * 1  1/111 (0.90%) 
Libido decreased * 1  1/111 (0.90%) 
Mania * 1  1/111 (0.90%) 
Panic attack * 1  1/111 (0.90%) 
Renal and urinary disorders   
Haematuria * 1  5/111 (4.50%) 
Renal failure acute * 1  4/111 (3.60%) 
Pollakiuria * 1  3/111 (2.70%) 
Dysuria * 1  2/111 (1.80%) 
Renal impairment * 1  2/111 (1.80%) 
Urinary incontinence * 1  2/111 (1.80%) 
Azotaemia * 1  1/111 (0.90%) 
Hydronephrosis * 1  1/111 (0.90%) 
Micturition urgency * 1  1/111 (0.90%) 
Nocturia * 1  1/111 (0.90%) 
Obstructive uropathy * 1  1/111 (0.90%) 
Urinary tract obstruction * 1  1/111 (0.90%) 
Urinary tract pain * 1  1/111 (0.90%) 
Reproductive system and breast disorders   
Haematospermia * 1  2/111 (1.80%) 
Oedema genital * 1  2/111 (1.80%) 
Breast pain * 1  1/111 (0.90%) 
Penile pain * 1  1/111 (0.90%) 
Vaginal haemorrhage * 1  1/111 (0.90%) 
Vulvovaginal pain * 1  1/111 (0.90%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  29/111 (26.13%) 
Cough * 1  20/111 (18.02%) 
Epistaxis * 1  12/111 (10.81%) 
Oropharyngeal pain * 1  10/111 (9.01%) 
Pleural effusion * 1  6/111 (5.41%) 
Rhinitis allergic * 1  4/111 (3.60%) 
Dysphonia * 1  3/111 (2.70%) 
Sinus congestion * 1  3/111 (2.70%) 
Lung consolidation * 1  2/111 (1.80%) 
Productive cough * 1  2/111 (1.80%) 
Haemoptysis * 1  1/111 (0.90%) 
Hiccups * 1  1/111 (0.90%) 
Increased upper airway secretion * 1  1/111 (0.90%) 
Lung infiltration * 1  1/111 (0.90%) 
Nasal congestion * 1  1/111 (0.90%) 
Nasal inflammation * 1  1/111 (0.90%) 
Paranasal sinus hypersecretion * 1  1/111 (0.90%) 
Pulmonary embolism * 1  1/111 (0.90%) 
Rales * 1  1/111 (0.90%) 
Respiratory tract congestion * 1  1/111 (0.90%) 
Restrictive pulmonary disease * 1  1/111 (0.90%) 
Rhinorrhoea * 1  1/111 (0.90%) 
Sinus disorder * 1  1/111 (0.90%) 
Skin and subcutaneous tissue disorders   
Rash * 1  17/111 (15.32%) 
Petechiae * 1  10/111 (9.01%) 
Pruritus * 1  8/111 (7.21%) 
Rash maculo-papular * 1  8/111 (7.21%) 
Skin lesion * 1  8/111 (7.21%) 
Dry skin * 1  6/111 (5.41%) 
Ecchymosis * 1  6/111 (5.41%) 
Alopecia * 1  5/111 (4.50%) 
Increased tendency to bruise * 1  5/111 (4.50%) 
Night sweats * 1  5/111 (4.50%) 
Rash macular * 1  4/111 (3.60%) 
Erythema * 1  3/111 (2.70%) 
Onychoclasis * 1  3/111 (2.70%) 
Purpura * 1  3/111 (2.70%) 
Rash erythematous * 1  3/111 (2.70%) 
Blister * 1  2/111 (1.80%) 
Dermatitis acneiform * 1  2/111 (1.80%) 
Ingrowing nail * 1  2/111 (1.80%) 
Skin discolouration * 1  2/111 (1.80%) 
Acne * 1  1/111 (0.90%) 
Decubitus ulcer * 1  1/111 (0.90%) 
Dermatitis * 1  1/111 (0.90%) 
Dermatitis allergic * 1  1/111 (0.90%) 
Dermatitis contact * 1  1/111 (0.90%) 
Haemorrhage subcutaneous * 1  1/111 (0.90%) 
Hyperhidrosis * 1  1/111 (0.90%) 
Intertrigo * 1  1/111 (0.90%) 
Nail disorder * 1  1/111 (0.90%) 
Nail ridging * 1  1/111 (0.90%) 
Skin fissures * 1  1/111 (0.90%) 
Skin hyperpigmentation * 1  1/111 (0.90%) 
Skin hypopigmentation * 1  1/111 (0.90%) 
Skin ulcer * 1  1/111 (0.90%) 
Sunburn * 1  1/111 (0.90%) 
Urticaria * 1  1/111 (0.90%) 
Vascular disorders   
Hypertension * 1  11/111 (9.91%) 
Hypotension * 1  6/111 (5.41%) 
Orthostatic hypotension * 1  2/111 (1.80%) 
Blood pressure fluctuation * 1  1/111 (0.90%) 
Flushing * 1  1/111 (0.90%) 
Varicose vein * 1  1/111 (0.90%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Darrin Beaupre
Organization: Pharmacyclics, Inc.
Phone: 855-427-8846
Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT01236391     History of Changes
Other Study ID Numbers: PCYC-1104-CA
PCI-32765 ( Other Identifier: Pharmacyclics )
First Submitted: October 18, 2010
First Posted: November 8, 2010
Results First Submitted: February 12, 2015
Results First Posted: March 13, 2015
Last Update Posted: August 28, 2015