Trial Outcomes & Findings for Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom's Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing (NCT NCT02604511)
NCT ID: NCT02604511
Last Updated: 2022-12-07
Results Overview
To asses the percentage of participants with a Partial Response (PR) (50% reduction or more in serum IgM) or better.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
4 years
Results posted on
2022-12-07
Participant Flow
Participant milestones
| Measure |
Ibrutinib
This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated Waldenstrom's macroglobulinemia (WM) patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration.
Ibrutinib
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Ibrutinib
This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated Waldenstrom's macroglobulinemia (WM) patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration.
Ibrutinib
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Disease Progression
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Participant ineligible
|
1
|
|
Overall Study
Intercurrent illness
|
1
|
Baseline Characteristics
Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom's Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing
Baseline characteristics by cohort
| Measure |
Ibrutinib
n=31 Participants
This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration.
Ibrutinib
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 yearsPopulation: All participants except one participant determined to be ineligible
To asses the percentage of participants with a Partial Response (PR) (50% reduction or more in serum IgM) or better.
Outcome measures
| Measure |
Ibrutinib
n=30 Participants
This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration.
Ibrutinib
|
|---|---|
|
Major Response Rate
|
26 Participants
|
PRIMARY outcome
Timeframe: 4 yearsPopulation: All participants except one participant determined to be ineligible
To asses the percentage of participants with an Minor Response (MR) (25% reduction or more in serum IgM) or better.
Outcome measures
| Measure |
Ibrutinib
n=30 Participants
This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration.
Ibrutinib
|
|---|---|
|
Best Overall Response Rate
|
30 Participants
|
SECONDARY outcome
Timeframe: 6 yearsPopulation: All participants except one determined to be ineligible
The amount of time between attainment of at least a minor response and disease progression.
Outcome measures
| Measure |
Ibrutinib
n=30 Participants
This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration.
Ibrutinib
|
|---|---|
|
Duration of Response
|
46 months
Interval 1.0 to 55.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 yearsPopulation: All participants except one determined to be ineligible
The amount of time between starting treatment and attaining at least a minor response to therapy
Outcome measures
| Measure |
Ibrutinib
n=30 Participants
This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration.
Ibrutinib
|
|---|---|
|
Time to Response
|
0.9 months
Interval 0.9 to 1.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 yearsPopulation: All participants except for one determined to be ineligible
The number of participants who have not experienced disease progression 6 years after therapy initiation
Outcome measures
| Measure |
Ibrutinib
n=30 Participants
This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration.
Ibrutinib
|
|---|---|
|
Progression Free Survival
|
24 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 yearsPopulation: All participants except one who was determined to be ineligible
The number of participants who are still living 6 years after initiation of ibrutinib
Outcome measures
| Measure |
Ibrutinib
n=30 Participants
This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration.
Ibrutinib
|
|---|---|
|
Overall Survival
|
30 Participants
|
Adverse Events
Ibrutinib
Serious events: 15 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ibrutinib
n=31 participants at risk
This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration.
Ibrutinib
|
|---|---|
|
Injury, poisoning and procedural complications
Head trauma
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Psychiatric disorders
Mania
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Cardiac disorders
Atrial fibrillation
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Non-Cardiac Chest pain
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Renal and urinary disorders
Kidney infection
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Fever
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Investigations
AST elevation
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Investigations
ALT elevation
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Drug-induced hepatitis
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Rectal bleeding
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Infections and infestations
Colitis
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Vascular disorders
Hematoma
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Cardiac disorders
Ventricular fibrillation
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Esophageal cancer
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Renal and urinary disorders
Kidney dysfunction
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Nervous system disorders
Stroke
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Infections and infestations
Pneumonia
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Infections and infestations
Prostatitis
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
Other adverse events
| Measure |
Ibrutinib
n=31 participants at risk
This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration.
Ibrutinib
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
22.6%
7/31 • Number of events 7 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Blood and lymphatic system disorders
Ecchymosis
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Cardiac disorders
Atrial fibrillation
|
16.1%
5/31 • Number of events 5 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Cardiac disorders
Bradycardia
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Cardiac disorders
Palpitations
|
16.1%
5/31 • Number of events 5 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Cardiac disorders
Pericarditis
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Cardiac disorders
Sinus bradycardia
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Cardiac disorders
Sinus tachycardia
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Ear and labyrinth disorders
Hearing impaired
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Ear and labyrinth disorders
Vertigo
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Endocrine disorders
Hypothyroidism
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Eye disorders
Blurred vision
|
9.7%
3/31 • Number of events 3 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Eye disorders
Cataract
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Eye disorders
Conjunctivitis
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Eye disorders
Dry eye
|
9.7%
3/31 • Number of events 3 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Eye disorders
Eye pain
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Eye disorders
Floaters
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Eye disorders
Watering eyes
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Bloating
|
9.7%
3/31 • Number of events 3 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Constipation
|
22.6%
7/31 • Number of events 7 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Diarrhea
|
77.4%
24/31 • Number of events 24 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Dry mouth
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Dysphagia
|
16.1%
5/31 • Number of events 5 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Eructation
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Flatulence
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
25.8%
8/31 • Number of events 8 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Melena
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
35.5%
11/31 • Number of events 11 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Nausea
|
35.5%
11/31 • Number of events 11 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
9.7%
3/31 • Number of events 3 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Oral pain
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Stomach flu
|
9.7%
3/31 • Number of events 3 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Vomiting
|
22.6%
7/31 • Number of events 7 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Gastrointestinal disorders
Diverticulitis
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Blood blister
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Brain bleed
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Chills
|
32.3%
10/31 • Number of events 10 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Dental implant
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Edema face
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Edema limbs
|
29.0%
9/31 • Number of events 9 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Esophageal spasm
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Fatigue
|
71.0%
22/31 • Number of events 22 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Fever
|
22.6%
7/31 • Number of events 7 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Flu-like symptoms
|
9.7%
3/31 • Number of events 3 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Hernia
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Irritability
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Localized edema
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Malaise
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Non-cardiac chest pain
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Pain
|
12.9%
4/31 • Number of events 4 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Poison ivy
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Sunburn
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Teeth grinding
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
General disorders
Varicose veins
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Immune system disorders
Allergic reaction
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Infections and infestations
Bronchial infection
|
9.7%
3/31 • Number of events 3 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Infections and infestations
Herpes zoster
|
12.9%
4/31 • Number of events 4 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Infections and infestations
Influenza
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Infections and infestations
Lung infection
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Infections and infestations
Lyme disease
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Infections and infestations
Mucosal infection
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Infections and infestations
Otitis media
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Infections and infestations
Papulopustular rash
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Infections and infestations
Paronychia
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Infections and infestations
Rectum fungus
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Infections and infestations
Sinusitis
|
22.6%
7/31 • Number of events 7 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Infections and infestations
Skin infection
|
29.0%
9/31 • Number of events 9 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Infections and infestations
Soft tissue infection
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Infections and infestations
Tooth infection
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Infections and infestations
Upper respiratory infection
|
48.4%
15/31 • Number of events 15 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Infections and infestations
Urinary tract infection
|
12.9%
4/31 • Number of events 4 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Injury, poisoning and procedural complications
Bone marrow procedure hemorrhage
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Injury, poisoning and procedural complications
Bruising
|
41.9%
13/31 • Number of events 13 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Injury, poisoning and procedural complications
Calf injury
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Injury, poisoning and procedural complications
Concussion
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Injury, poisoning and procedural complications
Fall
|
19.4%
6/31 • Number of events 6 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Injury, poisoning and procedural complications
Foot laceration
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Injury, poisoning and procedural complications
Fracture
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Injury, poisoning and procedural complications
Knee injury
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Investigations
Alanine aminotransferase increased
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Investigations
Blood bilirubin increased
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Investigations
Creatinine increased
|
16.1%
5/31 • Number of events 5 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Investigations
Lymphocyte count decreased
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Investigations
Neutrophil count decreased
|
9.7%
3/31 • Number of events 3 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Investigations
Platelet count decreased
|
22.6%
7/31 • Number of events 7 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Investigations
Urine output decreased
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Investigations
Weight loss
|
12.9%
4/31 • Number of events 4 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Investigations
White blood cell decreased
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.7%
3/31 • Number of events 3 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
38.7%
12/31 • Number of events 12 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
32.3%
10/31 • Number of events 10 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
12.9%
4/31 • Number of events 4 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Musculoskeletal and connective tissue disorders
Knee joint hyperflexion
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
61.3%
19/31 • Number of events 19 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
19.4%
6/31 • Number of events 6 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mucoid cyst
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sebaceous cyst
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Nervous system disorders
Ataxia
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Nervous system disorders
Carpal tunnel
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Nervous system disorders
Dizziness
|
16.1%
5/31 • Number of events 5 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Nervous system disorders
Headache
|
32.3%
10/31 • Number of events 10 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Nervous system disorders
Lethargy
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Nervous system disorders
Memory impairment
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Nervous system disorders
Paresthesia
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
19.4%
6/31 • Number of events 6 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Nervous system disorders
Presyncope
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Nervous system disorders
Syncope
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Nervous system disorders
Transient ischemic attack
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Nervous system disorders
Tremor
|
9.7%
3/31 • Number of events 3 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Nervous system disorders
Vasovagal reaction
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Psychiatric disorders
Anxiety
|
9.7%
3/31 • Number of events 3 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Psychiatric disorders
Confusion
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Psychiatric disorders
Insomnia
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Renal and urinary disorders
Hematuria
|
12.9%
4/31 • Number of events 4 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Renal and urinary disorders
Renal calculi
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Renal and urinary disorders
Urinary frequency
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Renal and urinary disorders
Urinary tract pain
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Reproductive system and breast disorders
Irregular menstruation
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.6%
7/31 • Number of events 7 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.1%
5/31 • Number of events 5 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.8%
8/31 • Number of events 8 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.1%
5/31 • Number of events 5 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Bee sting
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Eczematous Rash
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
25.8%
8/31 • Number of events 8 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
16.1%
5/31 • Number of events 5 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Onychoschizia
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.7%
3/31 • Number of events 3 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.1%
5/31 • Number of events 5 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Rash not otherwise specified
|
29.0%
9/31 • Number of events 9 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Seborrheic dermatitis
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Skin bleeding
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
9.7%
3/31 • Number of events 3 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Wart
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Vascular disorders
Hematoma
|
25.8%
8/31 • Number of events 8 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Vascular disorders
Hypertension
|
19.4%
6/31 • Number of events 6 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Vascular disorders
Phlebitis
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Vascular disorders
Vasculitis
|
3.2%
1/31 • Number of events 1 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
|
Surgical and medical procedures
Tooth extraction
|
6.5%
2/31 • Number of events 2 • Adverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months maximum). Deaths were assessed for up to 6 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place