Trial Outcomes & Findings for A Multicenter Phase 2 Study of Ibrutinib in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) With 17p Deletion (NCT NCT01744691)
NCT ID: NCT01744691
Last Updated: 2017-02-27
Results Overview
The primary objective of this study is to evaluate the efficacy of ibrutinib in terms of ORR according to an Independent Review Committee (IRC). ORR based upon IRC assessment is the proportion of responders in the all treated population. Responders were subjects who achieved partial response (PR) or better, ie, complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR, per IWCLL 2008 criteria with the clarification for treatment-related lymphocytosis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
145 participants
Primary outcome timeframe
The median time on study for all treated participants is 33.3 (range 0.5 - 40.1) months
Results posted on
2017-02-27
Participant Flow
One hundred forty-five subjects were enrolled and 144 subjects received at least 1 dose of PCI-32765 and constitute the all treated population and the safety analysis set.
Participant milestones
| Measure |
Ibrutinib
All subjects received ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.
Ibrutinib: All subjects received ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.
|
|---|---|
|
Overall Study
STARTED
|
144
|
|
Overall Study
COMPLETED
|
101
|
|
Overall Study
NOT COMPLETED
|
43
|
Reasons for withdrawal
| Measure |
Ibrutinib
All subjects received ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.
Ibrutinib: All subjects received ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.
|
|---|---|
|
Overall Study
Progressive Disease
|
18
|
|
Overall Study
Unacceptable toxicity, AE or death
|
18
|
|
Overall Study
Withdrawal of consent for treatment
|
3
|
|
Overall Study
Physician Decision
|
4
|
Baseline Characteristics
A Multicenter Phase 2 Study of Ibrutinib in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) With 17p Deletion
Baseline characteristics by cohort
| Measure |
PCI-32765
n=144 Participants
All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.
PCI-32765: All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
69 Participants
n=5 Participants
|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Gender
Female
|
48 Participants
n=5 Participants
|
|
Gender
Male
|
96 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The median time on study for all treated participants is 33.3 (range 0.5 - 40.1) monthsPopulation: Efficacy analyses were performed on all 144 treated subjects. The primary analysis (PA) used IRC assessment of efficacy endpoints. In the PA, there were no differences between the IRC and investigator responses. IRC assessment was no longer performed after the PA and the final analysis result report investigator-assessed efficacy outcomes.
The primary objective of this study is to evaluate the efficacy of ibrutinib in terms of ORR according to an Independent Review Committee (IRC). ORR based upon IRC assessment is the proportion of responders in the all treated population. Responders were subjects who achieved partial response (PR) or better, ie, complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR, per IWCLL 2008 criteria with the clarification for treatment-related lymphocytosis.
Outcome measures
| Measure |
Ibrutinib
n=144 Participants
All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.
ibrutinib: All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.
|
|---|---|
|
Overall Response Rate
|
77.8 % of participants with response by PI
Interval 70.3 to 83.8
|
SECONDARY outcome
Timeframe: From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closurePopulation: Participants who received at least 1 dose of PCI-32765 and constitute the all treated population.
Number of participants who had experienced at least one treatment emergent AE
Outcome measures
| Measure |
Ibrutinib
n=144 Participants
All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.
ibrutinib: All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs)
|
144 participants
|
Adverse Events
PCI-32765
Serious events: 76 serious events
Other events: 144 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PCI-32765
n=144 participants at risk
All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.
PCI-32765: All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.8%
4/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
2/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
8/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Acute myocardial infarction
|
1.4%
2/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Pericarditis
|
1.4%
2/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Cardiac failure
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Myocardial infarction
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Pericardial effusion
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Sinus node dysfunction
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Eye disorders
Iritis
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Colitis
|
1.4%
2/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
2/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Gastritis
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Stomatitis
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Vomiting
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Pyrexia
|
2.1%
3/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Fatigue
|
1.4%
2/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Asthenia
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
General physical health deterioration
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Localised oedema
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Oedema peripheral
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Hepatobiliary disorders
Cholecystitis
|
1.4%
2/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Pneumonia
|
14.6%
21/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Urinary tract infection
|
3.5%
5/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Cellulitis
|
2.8%
4/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Bronchitis
|
1.4%
2/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Pyelonephritis
|
1.4%
2/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Sepsis
|
1.4%
2/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Septic shock
|
1.4%
2/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Appendicitis
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Aspergillus infection
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Atypical pneumonia
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Bacteraemia
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Cystitis
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Empyema
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Epiglottitis
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Groin abscess
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Herpes simplex
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Influenza
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Lung infection
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Lymphadenitis bacterial
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Sinusitis fungal
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Staphylococcal sepsis
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Subcutaneous abscess
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Varicella zoster virus infection
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
2.1%
3/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.4%
2/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
2/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.4%
2/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Chondromalacia
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Dactylitis
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Richter's syndrome
|
4.2%
6/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
3.5%
5/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.4%
2/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
1.4%
2/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell small lymphocytic lymphoma
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma transformation
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer stage 0
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Syncope
|
1.4%
2/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Cerebrovascular accident
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Critical illness polyneuropathy
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Encephalopathy
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Psychiatric disorders
Psychotic disorder
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
2/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Renal and urinary disorders
Renal failure
|
1.4%
2/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Renal and urinary disorders
Renal infarct
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.1%
3/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis allergic
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Livedo reticularis
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Trichodysplasia spinulosa
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Vascular disorders
Arterial haemorrhage
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Vascular disorders
Hypertension
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Vascular disorders
Orthostatic hypotension
|
0.69%
1/144 • From first dose of PCI-32765 to within 30 days of last dose
|
Other adverse events
| Measure |
PCI-32765
n=144 participants at risk
All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.
PCI-32765: All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
22.9%
33/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.1%
29/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
16.0%
23/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.6%
21/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
5.6%
8/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Atrial fibrillation
|
11.1%
16/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Eye disorders
Vision blurred
|
11.1%
16/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Eye disorders
Visual acuity reduced
|
8.3%
12/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Eye disorders
Dry eye
|
7.6%
11/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Eye disorders
Lacrimation increased
|
7.6%
11/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Eye disorders
Eye irritation
|
5.6%
8/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Diarrhoea
|
43.8%
63/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Nausea
|
23.6%
34/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Constipation
|
14.6%
21/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
18/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
17/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Abdominal pain
|
9.7%
14/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Stomatitis
|
7.6%
11/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
8/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.6%
8/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Fatigue
|
37.5%
54/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Pyrexia
|
21.5%
31/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Oedema peripheral
|
19.4%
28/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Chills
|
6.2%
9/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Peripheral swelling
|
6.2%
9/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Upper respiratory tract infection
|
20.8%
30/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Urinary tract infection
|
20.8%
30/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Pneumonia
|
19.4%
28/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
18/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Sinusitis
|
11.1%
16/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Bronchitis
|
9.7%
14/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Cellulitis
|
6.2%
9/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Contusion
|
6.9%
10/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
8/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Weight increased
|
13.9%
20/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Weight decreased
|
11.1%
16/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.4%
28/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
12.5%
18/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.6%
11/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.2%
9/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.6%
8/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.6%
8/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
28.5%
41/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
19.4%
28/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.0%
23/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.8%
17/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.4%
15/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.6%
8/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
9.0%
13/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Headache
|
12.5%
18/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Dizziness
|
9.7%
14/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.3%
12/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Psychiatric disorders
Insomnia
|
8.3%
12/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Psychiatric disorders
Depression
|
6.9%
10/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Psychiatric disorders
Anxiety
|
5.6%
8/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Renal and urinary disorders
Haematuria
|
6.2%
9/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.9%
46/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
18/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.0%
13/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
12/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.9%
10/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.9%
10/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.6%
8/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
16.0%
23/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.0%
13/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
8.3%
12/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.6%
11/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
7.6%
11/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
9/144 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Vascular disorders
Hypertension
|
27.1%
39/144 • From first dose of PCI-32765 to within 30 days of last dose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place