Trial Outcomes & Findings for Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma (NCT NCT01980628)
NCT ID: NCT01980628
Last Updated: 2019-10-16
Results Overview
ORR is defined as the proportion of subjects who achieved complete response (CR), partial response (PR). Response criteria are as outlined in the International Working Group Criteria for NHL, Cheson (2007), with disease assessments performed by an independent review committee (IRC). Per Cheson: CR is defined as disappearance of all evidence of disease. PR is defined as regression of measurable disease and no new sites.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
Analysis was conducted with the cutoff date of 02 Nov 2017, with a median follow-up time of 33.1 months.
Results posted on
2019-10-16
Participant Flow
Participant milestones
| Measure |
Ibrutinib
Subjects receive daily dose of 560 mg of ibrutinib capsules.
|
|---|---|
|
Overall Study
STARTED
|
63
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
63
|
Reasons for withdrawal
| Measure |
Ibrutinib
Subjects receive daily dose of 560 mg of ibrutinib capsules.
|
|---|---|
|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Physician Decision
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
PD, Subj non-Compliant,Study Terminated
|
42
|
Baseline Characteristics
Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma
Baseline characteristics by cohort
| Measure |
Ibrutinib
n=63 Participants
Subjects receive a daily dose of 560 mg of ibrutinib capsules
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Analysis was conducted with the cutoff date of 02 Nov 2017, with a median follow-up time of 33.1 months.ORR is defined as the proportion of subjects who achieved complete response (CR), partial response (PR). Response criteria are as outlined in the International Working Group Criteria for NHL, Cheson (2007), with disease assessments performed by an independent review committee (IRC). Per Cheson: CR is defined as disappearance of all evidence of disease. PR is defined as regression of measurable disease and no new sites.
Outcome measures
| Measure |
Single Arm, Intent to Treat Population
n=63 Participants
|
|---|---|
|
ORR (Overall Response Rate)
|
46 Percentage of Participants
Interval 33.5 to 59.3
|
SECONDARY outcome
Timeframe: Analysis was conducted with the cutoff date of 02 Nov 2017, with a median follow-up time of 33.1 months.The DOR analyses is performed on the subset of subjects that achieve CR or PR as determined by IRC. DOR is calculated as the duration of time from the date of first response to the date of progression or death due to any cause.
Outcome measures
| Measure |
Single Arm, Intent to Treat Population
n=63 Participants
|
|---|---|
|
DOR (Duration of Response)
|
NA Months
Interval 16.7 to
Per IRC assessment, the median DOR was not reached
|
Adverse Events
Ibrutinib
Serious events: 29 serious events
Other events: 63 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Ibrutinib
n=63 participants at risk
ibrutinib capsules: 560 mg once daily
|
|---|---|
|
Blood and lymphatic system disorders
Autoimmune Haemolytic Anaemia
|
3.2%
2/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Blood and lymphatic system disorders
Haemolytic Anaemia
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Cardiac disorders
Atrial Fibrillation
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Cardiac disorders
Pericardial Effusion
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Gastrointestinal disorders
Pancreatitis
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Gastrointestinal disorders
Stomatitis
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
General disorders
Asthenia
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
General disorders
Non-Cardiac Chest Pain
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
General disorders
Pyrexia
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Infections and infestations
Pneumonia
|
7.9%
5/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Infections and infestations
Cellulitis
|
3.2%
2/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Infections and infestations
Sepsis
|
3.2%
2/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Infections and infestations
Escherichia Sepsis
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Infections and infestations
Infection
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Infections and infestations
Influenza
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Infections and infestations
Listeria Sepsis
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Infections and infestations
Lung Infection
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Infections and infestations
Parainfluenzae Virus Infection
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Metabolism and nutrition disorders
Fluid Overload
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Marginal Zone Lymphoma
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Nervous system disorders
Cerebral Haemorrhage
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Nervous system disorders
Cervical Radiculopathy
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Nervous system disorders
Transient Ischaemic Attack
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic Pneumonia
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Vascular disorders
Hypotension
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Injury, poisoning and procedural complications
Bronchial Injury
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Respiratory, thoracic and mediastinal disorders
Organising Pneumonia
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Vascular disorders
Embolism
|
1.6%
1/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
Other adverse events
| Measure |
Ibrutinib
n=63 participants at risk
ibrutinib capsules: 560 mg once daily
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
36.5%
23/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
23.8%
15/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Blood and lymphatic system disorders
Increased Tendency To Bruise
|
19.0%
12/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Cardiac disorders
Atrial Fibrillation
|
7.9%
5/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Eye disorders
Vision Blurred
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Gastrointestinal disorders
Diarrhoea
|
47.6%
30/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Gastrointestinal disorders
Nausea
|
31.7%
20/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Gastrointestinal disorders
Dyspepsia
|
19.0%
12/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Gastrointestinal disorders
Abdominal Pain
|
15.9%
10/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Gastrointestinal disorders
Constipation
|
15.9%
10/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
11.1%
7/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Gastrointestinal disorders
Stomatitis
|
12.7%
8/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
7/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Gastrointestinal disorders
Abdominal Distension
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
General disorders
Fatigue
|
46.0%
29/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
General disorders
Oedema Peripheral
|
23.8%
15/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
General disorders
Pyrexia
|
19.0%
12/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
General disorders
Asthenia
|
9.5%
6/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
25.4%
16/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Infections and infestations
Sinusitis
|
20.6%
13/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Infections and infestations
Bronchitis
|
11.1%
7/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Infections and infestations
Urinary Tract Infection
|
14.3%
9/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Infections and infestations
Oral Herpes
|
7.9%
5/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Infections and infestations
Conjunctivitis
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Infections and infestations
Cystitis
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Injury, poisoning and procedural complications
Fall
|
15.9%
10/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Injury, poisoning and procedural complications
Contusion
|
11.1%
7/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
9.5%
6/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Investigations
Weight Decreased
|
14.3%
9/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
7.9%
5/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Investigations
Blood Creatinine Increased
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
17.5%
11/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
15.9%
10/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
15.9%
10/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
17.5%
11/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.3%
9/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.1%
7/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.9%
5/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.8%
15/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
20.6%
13/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
15.9%
10/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.1%
7/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
7.9%
5/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Nervous system disorders
Dizziness
|
22.2%
14/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Nervous system disorders
Headache
|
20.6%
13/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Psychiatric disorders
Anxiety
|
17.5%
11/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Psychiatric disorders
Depression
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Renal and urinary disorders
Haematuria
|
11.1%
7/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.4%
16/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.6%
13/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.7%
8/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
9.5%
6/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
17.5%
11/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
9/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
9.5%
6/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
9.5%
6/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.9%
5/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Vascular disorders
Hypertension
|
15.9%
10/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Eye disorders
Dry Eye
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
General disorders
Pain
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Infections and infestations
Cellulitis
|
11.1%
7/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Infections and infestations
Pneumonia
|
9.5%
6/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Infections and infestations
Ear Infection
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Infections and infestations
Viral Upper Respiratory tract
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Metabolism and nutrition disorders
Dehydration
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Renal and urinary disorders
Dysuria
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
4.8%
3/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
7.9%
5/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
|
Vascular disorders
Hypotension
|
6.3%
4/63 • From the time of first ibrutinib dose until 30 days following the last dose of study drug
For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS
|
Additional Information
Isaiah Dimery, MD, Senior Medical Director
Pharmacyclics, LLC
Phone: 408-215-3579
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Agreement restrictions can vary and typically include (but are not limited to): Required submission of all material for sponsor review at least thirty days prior to the proposed date of any presentation or submission. Materials must remove Proprietary Information, excluding Data /Study results. All Sponsor's comments are required to be included. Sponsor may delay the presentation/submission upon Sponsor review of materials that are being proposed for presentation/submission.
- Publication restrictions are in place
Restriction type: OTHER