Trial Outcomes & Findings for Ibrutinib (PCI-32765) in Waldenstrom's Macroglobulinemia (NCT NCT01614821)
NCT ID: NCT01614821
Last Updated: 2020-01-21
Results Overview
To assess the overall response rate (\>25% reduction in serum IgM from baseline).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
4 years
Results posted on
2020-01-21
Participant Flow
Participant milestones
| Measure |
Treatment Arm
PCI-32765; ibrutinib
PCI-32765: Taken orally, once daily in the morning
|
|---|---|
|
Overall Study
STARTED
|
63
|
|
Overall Study
COMPLETED
|
63
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=63 Participants
PCI-32765; ibrutinib
PCI-32765: Taken orally, once daily in the morning
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=63 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=63 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=63 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 10.6 • n=63 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=63 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=63 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=63 Participants
|
PRIMARY outcome
Timeframe: 4 yearsTo assess the overall response rate (\>25% reduction in serum IgM from baseline).
Outcome measures
| Measure |
Treatment Arm
n=63 Participants
PCI-32765; ibrutinib
PCI-32765: Taken orally, once daily in the morning
|
|---|---|
|
Overall Response Rate
|
57 Participants
|
SECONDARY outcome
Timeframe: 4 yearsTo assess the safety and tolerability of PCI-32765 in symptomatic WM patients with relapsed/refractory disease. Grade \> or = 2 Adverse Events determined to be associated with PCI-32765 and subsequent outcomes will constitute the safety profile of PCI-32765 in WM. Percent of participants who experienced at least 1 grade 2 or higher treatment emergent adverse event.
Outcome measures
| Measure |
Treatment Arm
n=63 Participants
PCI-32765; ibrutinib
PCI-32765: Taken orally, once daily in the morning
|
|---|---|
|
Safety and Tolerability of PCI-32765
|
62 Participants
|
SECONDARY outcome
Timeframe: 6 yearsTo determine Progression Free Survival (PFS in symptomatic WM patients with relapsed/refractory disease. Participants were treated for 40 cycles and then followed for 2 years or until next therapy or death. 40 participants were censored prior to disease progression.
Outcome measures
| Measure |
Treatment Arm
n=63 Participants
PCI-32765; ibrutinib
PCI-32765: Taken orally, once daily in the morning
|
|---|---|
|
Determine Progression Free Survival
|
39 months
Interval 0.0 to 67.0
|
SECONDARY outcome
Timeframe: 6 yearsTime to Next Therapy is the duration of time from of starting ibrutinib until next therapy. Participants were treated for 40 cycles and then followed for 2 years or until next therapy or death. Participants had the option to continue ibrutinib commercially. 40 participants were censored while still on commercial ibrutinib therapy.
Outcome measures
| Measure |
Treatment Arm
n=63 Participants
PCI-32765; ibrutinib
PCI-32765: Taken orally, once daily in the morning
|
|---|---|
|
To Determine Time to Next Therapy (TTNT) of PCI-32765 in Symptomatic WM Patients With Relapsed/Refractory Disease
|
49 months
Interval 1.0 to 67.0
|
SECONDARY outcome
Timeframe: 4 yearsTo assess the major response rate (\>50% reduction in serum IgM from baseline)
Outcome measures
| Measure |
Treatment Arm
n=63 Participants
PCI-32765; ibrutinib
PCI-32765: Taken orally, once daily in the morning
|
|---|---|
|
Major Response Rates
|
49 Participants
|
SECONDARY outcome
Timeframe: 4 yearsTo assess the very good partial response rate (\>90% reduction in serum IgM from baseline)
Outcome measures
| Measure |
Treatment Arm
n=63 Participants
PCI-32765; ibrutinib
PCI-32765: Taken orally, once daily in the morning
|
|---|---|
|
Very Good Partial Response Rate
|
17 Participants
|
Adverse Events
Treatment Arm
Serious events: 30 serious events
Other events: 62 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment Arm
n=63 participants at risk
PCI-32765; ibrutinib
PCI-32765: Taken orally, once daily in the morning
|
|---|---|
|
General disorders
Fever and Tachycardia
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Flu
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Cardiac disorders
Atrial Fibrillation
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Blood and lymphatic system disorders
Neutropenic Fever and Chills
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Cellulitis
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
General disorders
Malaise
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Pneumonia
|
17.5%
11/63 • Number of events 11 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Endocarditis
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Herpes Zoster
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Nervous system disorders
Syncope
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Vascular disorders
Hematoma
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
General disorders
Fever
|
4.8%
3/63 • Number of events 3 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease Transformation DLBCL
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Blood and lymphatic system disorders
Anemia
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Upper Respiratory Infection
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Group A Streptococcus
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Investigations
Platelet Count Decreased
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Investigations
Neutrophil count Decreased
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the rectum
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Psychiatric disorders
Depression and Suicidal Ideation
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Cardiac disorders
Pericarditis
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Foot Infection
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Kidney Infection
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
Other adverse events
| Measure |
Treatment Arm
n=63 participants at risk
PCI-32765; ibrutinib
PCI-32765: Taken orally, once daily in the morning
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
11.1%
7/63 • Number of events 7 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Investigations
Alkaline phosphatase increased
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Blood and lymphatic system disorders
Anemia
|
63.5%
40/63 • Number of events 40 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Psychiatric disorders
Anxiety
|
9.5%
6/63 • Number of events 6 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
27.0%
17/63 • Number of events 17 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Investigations
Aspartate aminotransferase increased
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Cardiac disorders
Atrial Fibrillation
|
14.3%
9/63 • Number of events 9 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.9%
5/63 • Number of events 5 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Bladder Infection
|
4.8%
3/63 • Number of events 3 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Gastrointestinal disorders
Bloating
|
4.8%
3/63 • Number of events 3 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Investigations
Blood bilirubin increased
|
6.3%
4/63 • Number of events 4 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Eye disorders
Blurred vision
|
11.1%
7/63 • Number of events 7 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.8%
3/63 • Number of events 3 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Bronchial infection
|
11.1%
7/63 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Injury, poisoning and procedural complications
Bruising
|
12.7%
8/63 • Number of events 8 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Eye disorders
Cataract
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
General disorders
Chills
|
4.8%
3/63 • Number of events 3 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Eye disorders
Conjunctivitis
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Gastrointestinal disorders
Constipation
|
12.7%
8/63 • Number of events 8 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.5%
11/63 • Number of events 11 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Investigations
Creatinine increased
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.3%
4/63 • Number of events 4 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Psychiatric disorders
Depression
|
6.3%
4/63 • Number of events 4 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Gastrointestinal disorders
Diarrhea
|
31.7%
20/63 • Number of events 20 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Nervous system disorders
Dizziness
|
17.5%
11/63 • Number of events 11 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Skin and subcutaneous tissue disorders
Dry eye
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Nervous system disorders
Dysgeusia
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Gastrointestinal disorders
Dysphagia
|
4.8%
3/63 • Number of events 3 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.5%
6/63 • Number of events 6 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
General disorders
Facial edema
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
General disorders
Edema limbs
|
14.3%
9/63 • Number of events 9 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.7%
8/63 • Number of events 8 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Eye infection
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Eye disorders
Eye pain
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Injury, poisoning and procedural complications
Fall
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
General disorders
Fatigue
|
52.4%
33/63 • Number of events 33 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
General disorders
Fever
|
20.6%
13/63 • Number of events 13 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
General disorders
Fly-like symptoms
|
6.3%
4/63 • Number of events 4 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Injury, poisoning and procedural complications
Fracture
|
6.3%
4/63 • Number of events 4 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
19.0%
12/63 • Number of events 12 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Gum infection
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Nervous system disorders
Headache
|
17.5%
11/63 • Number of events 11 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Ear and labyrinth disorders
Hearing impaired
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Vascular disorders
Hematoma
|
7.9%
5/63 • Number of events 5 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Renal and urinary disorders
Hematuria
|
6.3%
4/63 • Number of events 4 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Gastrointestinal disorders
Hemorrhoidal hemmorhage
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Vascular disorders
Hot flashes
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Vascular disorders
Hypertension
|
14.3%
9/63 • Number of events 9 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.9%
5/63 • Number of events 5 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.3%
4/63 • Number of events 4 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Vascular disorders
Hypotension
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Endocrine disorders
Hypothyroidism
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Psychiatric disorders
Insomnia
|
7.9%
5/63 • Number of events 5 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Reproductive system and breast disorders
Irregular menstruation
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Lip infection
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Investigations
Lipase increased
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Lung infection
|
22.2%
14/63 • Number of events 14 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Vascular disorders
Lymphedema
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
General disorders
Malaise
|
9.5%
6/63 • Number of events 6 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Mucosal infection
|
4.8%
3/63 • Number of events 3 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Gastrointestinal disorders
Oral Mucositis
|
12.7%
8/63 • Number of events 8 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
22.2%
14/63 • Number of events 14 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Nail infection
|
4.8%
3/63 • Number of events 3 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
11.1%
7/63 • Number of events 7 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.8%
3/63 • Number of events 3 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
9/63 • Number of events 9 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Investigations
Neutrophil count decreased
|
41.3%
26/63 • Number of events 26 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
General disorders
Non-cardiac chest pain
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
6.3%
4/63 • Number of events 4 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Otitis media
|
4.8%
3/63 • Number of events 3 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
General disorders
Pain
|
11.1%
7/63 • Number of events 7 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Cardiac disorders
Palpiatations
|
4.8%
3/63 • Number of events 3 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Nervous system disorders
Paresthesia
|
11.1%
7/63 • Number of events 7 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Penile Infection
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
14.3%
9/63 • Number of events 9 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
19.0%
12/63 • Number of events 12 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Pharyngitis
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Investigations
Platelet count decreased
|
46.0%
29/63 • Number of events 29 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
15.9%
10/63 • Number of events 10 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Gastrointestinal disorders
Proctitis
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
7.9%
5/63 • Number of events 5 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.8%
3/63 • Number of events 3 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.1%
7/63 • Number of events 7 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Gastrointestinal disorders
Rectal perforation
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Renal and urinary disorders
Renal calculi
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Eye disorders
Retinal detachment
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Eye disorders
Retinal tear
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Skin and subcutaneous tissue disorders
scalp pain
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Cardiac disorders
Sick sinus syndrome
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Cardiac disorders
Sinus bradycardia
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Cardiac disorders
Sinus tachycardia
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Sinusitis
|
33.3%
21/63 • Number of events 21 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Skin infection
|
17.5%
11/63 • Number of events 11 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Soft tissue infection
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Nervous system disorders
Stroke
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Nervous system disorders
Syncope
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Ear and labyrinth disorders
Tinnitis
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Tooth infection
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Gastrointestinal disorders
Toothache
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Upper respiratory infection
|
30.2%
19/63 • Number of events 19 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
9/63 • Number of events 9 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Renal and urinary disorders
urinary tract obstruction
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Renal and urinary disorders
Urinary tract pain
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Renal and urinary disorders
Urinary urgency
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Vaginal infection
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Cardiac disorders
Ventricular arrhythmia
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
7/63 • Number of events 7 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Eye disorders
Watering eyes
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Investigations
Weight gain
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Investigations
Weight loss
|
6.3%
4/63 • Number of events 4 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Investigations
White blood cell decreased
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Injury, poisoning and procedural complications
Wound complication
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
|
Infections and infestations
Wound infection
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from Cycle 1 Day 1 through 30 days after discontinuing protocol ibrutinib therapy, an average of 3 years.
Grade 2 and above treatment emergent adverse events were collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place