RESONATE™: A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Sponsor
Pharmacyclics LLC. (Industry)
Overall Status
Completed
CT.gov ID
NCT01578707
Collaborator
Janssen Research & Development, LLC (Industry)
391
76
2
76.8
5.1
0.1
Study Details
Study Description
Brief Summary
The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
Study PCYC-1112-CA is a randomized, multicenter, open-label, phase 3 study of the Bruton's Tyrosine Kinase (BTK) inhibitor Ibrutinib (PCI-32765) versus Ofatumumab in patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.
Patients randomized to the ofatumumab arm may be considered to receive next subsequent therapy with ibrutinib.
Study Design
Study Type:
Interventional
Actual Enrollment
:
391 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Actual Study Start Date
:
Jun 1, 2012
Actual Primary Completion Date
:
Nov 1, 2013
Actual Study Completion Date
:
Oct 25, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Ofatumumab (Arm A) An anti-CD20 monoclonal antibody |
Drug: ofatumumab
The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.
Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)
|
| Experimental: ibrutinib (Arm B) A Bruton Tyrosine Kinase Inhibitor |
Drug: ibrutinib
ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity
|
Outcome Measures
Primary Outcome Measures
- PFS (Progression Free Survival) by Independent Review Committee (IRC), Limited to the Time of Primary Analysis 06 November 2013 [Analysis was conducted after observing approximately 117 PFS events, which occurred about 18 months after the first subject was enrolled.]
The primary objective of this study was to evaluate the efficacy of ibrutinib compared to ofatumumab based on independent review committee (IRC) assessment of progression-free survival (PFS) according to 2008 IWCLL guidelines.
Secondary Outcome Measures
- Overall Response Rate (ORR) by Independent Review Committee (IRC) [About 18 months after the first subject was enrolled]
Overall Response Rate per the IWCLL 2008 criteria as assessed by IRC, limited to the time of primary analysis 06 November 2013
- OS (Overall Survival) [OS analysis was conducted at the time of study closure, including up to 6 years of study follow-up]
OS analysis was conducted at the time of study closure, with no adjustment for crossover from the ofatumumab arm to the ibrutinib arm
- Rate of Sustained Hemoglobin and Platelet Improvement [From study initiation to study closure, including up to 6 years of study follow-up]
Proportion of subjects with hemoglobin (HgB) increase >=20 g/L and platelet (PLT) increase >=50% over baseline continuously for >=56 days without blood transfusions or growth factors.
Other Outcome Measures
- Progression Free Survival (PFS) by Investigator With up to 6 Years of Study Follow-up [From study initiation to study closure, including up to 6 years of study follow-up]
Long-Term Progression Free Survival as assessed by the investigator with up to 6 years of study follow-up
- Overall Response Rate (ORR) by Investigator [From study initiation to study closure, including up to 6 years of study follow-up]
Overall response per the IWCLL 2008 criteria as assessed by Investigator with up to 6 years of study follow-up
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
ECOG performance status of 0-1.
-
Diagnosis of CLL or SLL that meets IWCLL 2008 criteria.
-
Active disease meeting at least 1 of the IWCLL 2008 criteria for requiring treatment.
-
Must have received at least one prior therapy for CLL/SLL.
-
Considered not appropriate for treatment or retreatment with purine analog based therapy.
-
Measurable nodal disease by CT.
-
Patients must be able to receive outpatient treatment and laboratory monitoring at the institution that administers study drug for the entire study.
Exclusion Criteria:
-
Known CNS lymphoma or leukemia.
-
No documentation of cytogenetic and/or FISH in patient records prior to first dose of study drug.
-
Any history of Richter's transformation or prolymphocytic leukemia.
-
Uncontrolled Autoimmune Hemolytic Anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP).
-
Prior exposure to ofatumumab or to ibrutinib.
-
Prior autologous transplant within 6 months prior to first dose of study drug.
-
Prior allogeneic stem cell transplant within 6 months or with any evidence of active graft versus host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug.
-
History of prior malignancy, with the exception of certain skin cancers and malignancies treated with curative intent and with no evidence of active disease for more than 3 years.
-
Serologic status reflecting active hepatitis B or C infection.
-
Unable to swallow capsules or disease significantly affecting gastrointestinal function.
-
Uncontrolled active systemic fungal, bacterial, viral, or other infection.
-
History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug.
-
Requires anticoagulation with warfarin.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site #408 | La Jolla | California | United States | 92093-0698 |
| 2 | Site #377 | Los Angeles | California | United States | 90095 |
| 3 | Site #403 | Santa Maria | California | United States | 93454 |
| 4 | Site #038 | Stanford | California | United States | 94035 |
| 5 | Site #411 | Norwalk | Connecticut | United States | 06856 |
| 6 | Site #107 | Marietta | Georgia | United States | 30060 |
| 7 | Site # 379 | Evansville | Indiana | United States | 47713 |
| 8 | Site # 390 | Boston | Massachusetts | United States | 02114 |
| 9 | Site # 391 | Boston | Massachusetts | United States | 02115 |
| 10 | Site # 349 | Boston | Massachusetts | United States | 02215 |
| 11 | Site # 130 | Detroit | Michigan | United States | 48201 |
| 12 | Site # 406 | Rochester | Minnesota | United States | 55901 |
| 13 | Site # 059 | New Brunswick | New Jersey | United States | 08903 |
| 14 | Site # 350 | New Hyde Park | New York | United States | 11042 |
| 15 | Site # 200 | New York | New York | United States | 10065 |
| 16 | Site # 127 | Rochester | New York | United States | 14642-0001 |
| 17 | Site # 197 | Cincinnati | Ohio | United States | 45291 |
| 18 | Site # 217 | Columbus | Ohio | United States | 43210 |
| 19 | Site # 402 | Philadelphia | Pennsylvania | United States | 19104 |
| 20 | Site # 396 | Greenville | South Carolina | United States | 29601 |
| 21 | Site # 410 | Nashville | Tennessee | United States | 37232-5505 |
| 22 | Site # 032 | Houston | Texas | United States | 77030 |
| 23 | Site # 381 | Laredo | Texas | United States | 78041 |
| 24 | Site # 210 | Charlottesville | Virginia | United States | 22908 |
| 25 | Site # 404 | Seattle | Washington | United States | 98109 |
| 26 | Site # 500 | St. Leonards | New South Wales | Australia | 2065 |
| 27 | Site # 503 | Brisbane | Queensland | Australia | 4102 |
| 28 | Site # 199 | East Melbourne | Victoria | Australia | 3002 |
| 29 | Site # 501 | Fitzroy | Victoria | Australia | 3109 |
| 30 | Site # 502 | Nedlands | Western Australia | Australia | 6009 |
| 31 | Site # 509 | Graz | Austria | 8036 | |
| 32 | Site # 508 | Linz | Austria | 4010 | |
| 33 | Site # 504 | Salzburg | Austria | 5020 | |
| 34 | Site # 505 | Vienna | Austria | A-1090 | |
| 35 | Site # 506 | Wein | Austria | 1160 | |
| 36 | Site # 507 | Wels | Austria | A-4600 | |
| 37 | Site # 393 | Antwerpen | Belgium | 2060 | |
| 38 | Site # 519 | Argenteuil | France | 95107 | |
| 39 | Site # 511 | Bobigny | France | 93009 | |
| 40 | Site # 515 | Bordeaux | France | 33076 | |
| 41 | Site # 516 | Caen | France | 14033 | |
| 42 | Site # 513 | Clermont Ferrand | France | 63100 | |
| 43 | Site # 510 | Marseille | France | 13273 | |
| 44 | Site # 520 | Nantes | France | 44000 | |
| 45 | Site # 518 | Rennes | France | 35033 | |
| 46 | Site # 517 | Vandœuvre-lès-Nancy | France | 54511 | |
| 47 | Site # 570 | Dublin | Ireland | 8 | |
| 48 | Site # 528 | Dublin | Ireland | 9 | |
| 49 | Site # 096 | Galway | Ireland | ||
| 50 | Site # 522 | Milano | Italy | 20089 | |
| 51 | Site # 523 | Milano | Italy | 20132 | |
| 52 | Site # 526 | Milano | Italy | 20162 | |
| 53 | Site # 524 | Modena | Italy | 41124 | |
| 54 | Site # 527 | Padova | Italy | 35128 | |
| 55 | Site # 529 | Gdansk | Poland | 80-952 | |
| 56 | Site # 531 | Lodz | Poland | 93-510 | |
| 57 | Site # 535 | Barcelona | Spain | 08025 | |
| 58 | Site # 534 | Barcelona | Spain | 08035 | |
| 59 | Site # 533 | Barcelona | Spain | 08036 | |
| 60 | Site # 539 | Coruna | Spain | 15006A | |
| 61 | Site # 540 | Madrid | Spain | 28033 | |
| 62 | Site # 537 | Madrid | Spain | 28050 | |
| 63 | Site # 536 | Madrid | Spain | 28222 | |
| 64 | Site # 538 | Pamplona | Spain | 31008 | |
| 65 | Site # 549 | Colchester | Essex | United Kingdom | CO4 5JL |
| 66 | Site # 543 | Sutton | Surrey | United Kingdom | SM2 5PT |
| 67 | Site # 551 | Bournemouth | United Kingdom | BH7 7DW | |
| 68 | Site # 553 | Canterbury | United Kingdom | CT1 3NG | |
| 69 | Site # 546 | Cardiff | United Kingdom | CF14 4XW | |
| 70 | Site # 554 | Headington | United Kingdom | OX3 7LJ | |
| 71 | Site # 550 | Leeds | United Kingdom | LS9 7TF | |
| 72 | Site # 552 | Liverpool | United Kingdom | L7 8XP | |
| 73 | Site # 544 | London | United Kingdom | SE5 9RS | |
| 74 | Site # 548 | Nottingham | United Kingdom | NG5 1PB | |
| 75 | Site # 545 | Southampton | United Kingdom | SO16 6YD | |
| 76 | Site # 541 | Withington | United Kingdom | M20 4BX |
Sponsors and Collaborators
- Pharmacyclics LLC.
- Janssen Research & Development, LLC
Investigators
- Study Director: Anita Szoke, MD, Pharmacyclics LLC.
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Pharmacyclics LLC.
ClinicalTrials.gov Identifier:
NCT01578707
Other Study ID Numbers:
- PCYC-1112-CA
- 2012-000694-23
First Posted:
Apr 17, 2012
Last Update Posted:
Dec 18, 2019
Last Verified:
Dec 1, 2019
Keywords provided by Pharmacyclics LLC.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Ofatumumab (Arm A) | Ibrutinib (Arm B) |
|---|---|---|
| Arm/Group Description | An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks) | A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity |
| Period Title: Overall Study | ||
| STARTED | 196 | 195 |
| COMPLETED | 196 | 195 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Ofatumumab (Arm A) | Ibrutinib (Arm B) | Total |
|---|---|---|---|
| Arm/Group Description | An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks) | A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity | Total of all reporting groups |
| Overall Participants | 196 | 195 | 391 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
75
38.3%
|
77
39.5%
|
152
38.9%
|
| >=65 years |
121
61.7%
|
118
60.5%
|
239
61.1%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
66.8
(8.88)
|
66.1
(10.15)
|
66.5
(9.53)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
59
30.1%
|
66
33.8%
|
125
32%
|
| Male |
137
69.9%
|
129
66.2%
|
266
68%
|
Outcome Measures
| Title | PFS (Progression Free Survival) by Independent Review Committee (IRC), Limited to the Time of Primary Analysis 06 November 2013 |
|---|---|
| Description | The primary objective of this study was to evaluate the efficacy of ibrutinib compared to ofatumumab based on independent review committee (IRC) assessment of progression-free survival (PFS) according to 2008 IWCLL guidelines. |
| Time Frame | Analysis was conducted after observing approximately 117 PFS events, which occurred about 18 months after the first subject was enrolled. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ofatumumab (Arm A) | Ibrutinib (Arm B) |
|---|---|---|
| Arm/Group Description | An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks) | A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity |
| Measure Participants | 196 | 195 |
| Median (95% Confidence Interval) [months] |
8.1
|
NA
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Ofatumumab (Arm A) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Overall Response Rate (ORR) by Independent Review Committee (IRC) |
|---|---|
| Description | Overall Response Rate per the IWCLL 2008 criteria as assessed by IRC, limited to the time of primary analysis 06 November 2013 |
| Time Frame | About 18 months after the first subject was enrolled |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ofatumumab (Arm A) | Ibrutinib (Arm B) |
|---|---|---|
| Arm/Group Description | An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks) | A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity |
| Measure Participants | 196 | 195 |
| Number [percentage of participants] |
4.1
2.1%
|
42.6
21.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Ofatumumab (Arm A) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.0001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | OS (Overall Survival) |
|---|---|
| Description | OS analysis was conducted at the time of study closure, with no adjustment for crossover from the ofatumumab arm to the ibrutinib arm |
| Time Frame | OS analysis was conducted at the time of study closure, including up to 6 years of study follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ofatumumab (Arm A) | Ibrutinib (Arm B) |
|---|---|---|
| Arm/Group Description | An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks) | A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity |
| Measure Participants | 196 | 195 |
| Median (95% Confidence Interval) [months] |
65.1
|
67.7
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Ofatumumab (Arm A) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1653 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Rate of Sustained Hemoglobin and Platelet Improvement |
|---|---|
| Description | Proportion of subjects with hemoglobin (HgB) increase >=20 g/L and platelet (PLT) increase >=50% over baseline continuously for >=56 days without blood transfusions or growth factors. |
| Time Frame | From study initiation to study closure, including up to 6 years of study follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ofatumumab (Arm A) | Ibrutinib (Arm B) |
|---|---|---|
| Arm/Group Description | An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks) | A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity |
| Measure Participants | 196 | 195 |
| Hgb Improvement in patient with baseline anemia |
32.6
16.6%
|
69.7
35.7%
|
| Platelet improvement in baseline thrombocytopenia |
9.4
4.8%
|
78.4
40.2%
|
| Title | Progression Free Survival (PFS) by Investigator With up to 6 Years of Study Follow-up |
|---|---|
| Description | Long-Term Progression Free Survival as assessed by the investigator with up to 6 years of study follow-up |
| Time Frame | From study initiation to study closure, including up to 6 years of study follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ofatumumab (Arm A) | Ibrutinib (Arm B) |
|---|---|---|
| Arm/Group Description | An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks) | A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity |
| Measure Participants | 196 | 195 |
| Median (95% Confidence Interval) [months] |
8.1
|
44.1
|
| Title | Overall Response Rate (ORR) by Investigator |
|---|---|
| Description | Overall response per the IWCLL 2008 criteria as assessed by Investigator with up to 6 years of study follow-up |
| Time Frame | From study initiation to study closure, including up to 6 years of study follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ofatumumab (Arm A) | Ibrutinib (Arm B) |
|---|---|---|
| Arm/Group Description | An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks) | A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity |
| Measure Participants | 196 | 195 |
| Number [percentage of participants] |
22.4
11.4%
|
87.7
45%
|
Adverse Events
| Time Frame | From first dose of study drug to within 30 days of last dose. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | 196 subjects were randomized to the Ofa arm with 191 received drug thus 5 patients were not included in the number of participants at risk. | |||
| Arm/Group Title | Ofatumumab (Arm A) | Ibrutinib (Arm B) | ||
| Arm/Group Description | An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks) | A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity | ||
All Cause Mortality |
||||
| Ofatumumab (Arm A) | Ibrutinib (Arm B) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 16/191 (8.4%) | 24/195 (12.3%) | ||
Serious Adverse Events |
||||
| Ofatumumab (Arm A) | Ibrutinib (Arm B) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 59/191 (30.9%) | 141/195 (72.3%) | ||
| Blood and lymphatic system disorders | ||||
| Febrile Neutropenia | 4/191 (2.1%) | 7/195 (3.6%) | ||
| Anaemia | 4/191 (2.1%) | 5/195 (2.6%) | ||
| Neutropenia | 2/191 (1%) | 4/195 (2.1%) | ||
| Spontaneous Haematoma | 0/191 (0%) | 2/195 (1%) | ||
| Lymphadenopathy | 0/191 (0%) | 1/195 (0.5%) | ||
| Thrombocytopenia | 0/191 (0%) | 1/195 (0.5%) | ||
| Autoimmune Haemolytic Anaemia | 1/191 (0.5%) | 0/195 (0%) | ||
| Haemolytic Anaemia | 1/191 (0.5%) | 0/195 (0%) | ||
| Methaemoglobinaemia | 1/191 (0.5%) | 0/195 (0%) | ||
| Cardiac disorders | ||||
| Atrial Fibrillation | 1/191 (0.5%) | 11/195 (5.6%) | ||
| Cardiac Failure Congestive | 0/191 (0%) | 3/195 (1.5%) | ||
| Atrioventricular Block | 0/191 (0%) | 2/195 (1%) | ||
| Cardiac Failure | 1/191 (0.5%) | 2/195 (1%) | ||
| Myocardial infarction | 1/191 (0.5%) | 2/195 (1%) | ||
| Acute myocardial infarction | 1/191 (0.5%) | 1/195 (0.5%) | ||
| Angina Pectoris | 0/191 (0%) | 1/195 (0.5%) | ||
| Aortic Valve Disease | 0/191 (0%) | 1/195 (0.5%) | ||
| Atrial Tachycardia | 0/191 (0%) | 1/195 (0.5%) | ||
| Bradycardia | 0/191 (0%) | 1/195 (0.5%) | ||
| Cardiac Arrest | 0/191 (0%) | 1/195 (0.5%) | ||
| Myocardial Ischaemia | 0/191 (0%) | 1/195 (0.5%) | ||
| Palpitations | 0/191 (0%) | 1/195 (0.5%) | ||
| Pericardial Effusion | 0/191 (0%) | 1/195 (0.5%) | ||
| Supraventricular Tachycardia | 1/191 (0.5%) | 1/195 (0.5%) | ||
| Sinus Tachycardia | 1/191 (0.5%) | 0/195 (0%) | ||
| Ear and labyrinth disorders | ||||
| Hypoacusis | 0/191 (0%) | 1/195 (0.5%) | ||
| Eye disorders | ||||
| Vitreous Haemorrhage | 0/191 (0%) | 1/195 (0.5%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 1/191 (0.5%) | 6/195 (3.1%) | ||
| Vomiting | 0/191 (0%) | 5/195 (2.6%) | ||
| Abdominal Pain | 1/191 (0.5%) | 4/195 (2.1%) | ||
| Nausea | 0/191 (0%) | 3/195 (1.5%) | ||
| Umbilical Hernia | 0/191 (0%) | 2/195 (1%) | ||
| Upper Gastrointestinal Haemorrhage | 0/191 (0%) | 2/195 (1%) | ||
| Abdominal Pain Upper | 0/191 (0%) | 1/195 (0.5%) | ||
| Anorectal Discomfort | 0/191 (0%) | 1/195 (0.5%) | ||
| Duodenal Perforation | 0/191 (0%) | 1/195 (0.5%) | ||
| Dysphagia | 0/191 (0%) | 1/195 (0.5%) | ||
| Enteritis | 0/191 (0%) | 1/195 (0.5%) | ||
| Intestinal Obstruction | 0/191 (0%) | 1/195 (0.5%) | ||
| Large Intestinal Obstruction | 0/191 (0%) | 1/195 (0.5%) | ||
| Mucous stools | 0/191 (0%) | 1/195 (0.5%) | ||
| Oesophageal Obstruction | 0/191 (0%) | 1/195 (0.5%) | ||
| Oesophageal spasm | 0/191 (0%) | 1/195 (0.5%) | ||
| Pancreatitis | 0/191 (0%) | 1/195 (0.5%) | ||
| Poor Dental Condition | 0/191 (0%) | 1/195 (0.5%) | ||
| Rectal haemorrhage | 0/191 (0%) | 1/195 (0.5%) | ||
| Stomatitis | 0/191 (0%) | 1/195 (0.5%) | ||
| Constipation | 1/191 (0.5%) | 0/195 (0%) | ||
| Malabsorption | 1/191 (0.5%) | 0/195 (0%) | ||
| General disorders | ||||
| Pyrexia | 4/191 (2.1%) | 15/195 (7.7%) | ||
| Non-Cardiac Chest Pain | 0/191 (0%) | 3/195 (1.5%) | ||
| Malaise | 0/191 (0%) | 2/195 (1%) | ||
| Sudden Death | 0/191 (0%) | 2/195 (1%) | ||
| Asthenia | 0/191 (0%) | 1/195 (0.5%) | ||
| Catheter Site Pain | 0/191 (0%) | 1/195 (0.5%) | ||
| Chills | 0/191 (0%) | 1/195 (0.5%) | ||
| Cyst | 0/191 (0%) | 1/195 (0.5%) | ||
| Fatigue | 0/191 (0%) | 1/195 (0.5%) | ||
| General Physical Health Deterioration | 0/191 (0%) | 1/195 (0.5%) | ||
| Influenza Like Illness | 0/191 (0%) | 1/195 (0.5%) | ||
| Injection Site Extravasation | 0/191 (0%) | 1/195 (0.5%) | ||
| Effusion | 1/191 (0.5%) | 0/195 (0%) | ||
| Hepatobiliary disorders | ||||
| Cholecystitis | 0/191 (0%) | 1/195 (0.5%) | ||
| Cholestasis | 0/191 (0%) | 1/195 (0.5%) | ||
| Immune system disorders | ||||
| Anaphylactic Shock | 1/191 (0.5%) | 0/195 (0%) | ||
| Infections and infestations | ||||
| Pneumonia | 12/191 (6.3%) | 42/195 (21.5%) | ||
| Urinary Tract Infection | 0/191 (0%) | 9/195 (4.6%) | ||
| Cellulitis | 1/191 (0.5%) | 8/195 (4.1%) | ||
| Sepsis | 2/191 (1%) | 8/195 (4.1%) | ||
| Lung Infection | 0/191 (0%) | 7/195 (3.6%) | ||
| Escherichia Urinary Tract Infection | 0/191 (0%) | 4/195 (2.1%) | ||
| Lower Respiratory Tract Infection | 2/191 (1%) | 4/195 (2.1%) | ||
| Upper Respiratory Tract Infection | 4/191 (2.1%) | 4/195 (2.1%) | ||
| Infection | 1/191 (0.5%) | 3/195 (1.5%) | ||
| Aspergillus Infection | 0/191 (0%) | 2/195 (1%) | ||
| Bronchitis | 2/191 (1%) | 2/195 (1%) | ||
| Bronchopulmonary Aspergillosis | 0/191 (0%) | 2/195 (1%) | ||
| Gastroenteritis | 0/191 (0%) | 2/195 (1%) | ||
| Gastroenteritis Viral | 0/191 (0%) | 2/195 (1%) | ||
| Herpes Zoster | 1/191 (0.5%) | 2/195 (1%) | ||
| Influenza | 2/191 (1%) | 2/195 (1%) | ||
| Neutropenic Sepsis | 2/191 (1%) | 2/195 (1%) | ||
| Pneumocystis Jirovecii Ppneumonia | 1/191 (0.5%) | 2/195 (1%) | ||
| Pneumonia Pseudomonal | 1/191 (0.5%) | 2/195 (1%) | ||
| Pneumonia Staphylococcal | 0/191 (0%) | 2/195 (1%) | ||
| Sinusitis | 0/191 (0%) | 2/195 (1%) | ||
| Urosepsis | 0/191 (0%) | 2/195 (1%) | ||
| Bacteraemia | 2/191 (1%) | 1/195 (0.5%) | ||
| Bacterial Infection | 0/191 (0%) | 1/195 (0.5%) | ||
| Bacteroides Bacteraemia | 0/191 (0%) | 1/195 (0.5%) | ||
| Bronchitis Bacterial | 0/191 (0%) | 1/195 (0.5%) | ||
| Campylobacter Gastroenteritis | 0/191 (0%) | 1/195 (0.5%) | ||
| Clostridium Difficile Colitis | 0/191 (0%) | 1/195 (0.5%) | ||
| Clostridium Difficile Infection | 0/191 (0%) | 1/195 (0.5%) | ||
| Empyema | 0/191 (0%) | 1/195 (0.5%) | ||
| Enterococcal Iinfection | 0/191 (0%) | 1/195 (0.5%) | ||
| Enterococcal Sepsis | 0/191 (0%) | 1/195 (0.5%) | ||
| Enterocolitis Infectious | 0/191 (0%) | 1/195 (0.5%) | ||
| Folliculitis | 1/191 (0.5%) | 1/195 (0.5%) | ||
| Gastrointestinal Infection | 0/191 (0%) | 1/195 (0.5%) | ||
| H1N1 Influenza | 0/191 (0%) | 1/195 (0.5%) | ||
| Haemophilus Bacteraemia | 0/191 (0%) | 1/195 (0.5%) | ||
| Haemophilus Infection | 0/191 (0%) | 1/195 (0.5%) | ||
| Haemophilus Sepsis | 0/191 (0%) | 1/195 (0.5%) | ||
| Herpes Virus Infection | 0/191 (0%) | 1/195 (0.5%) | ||
| Impetigo | 0/191 (0%) | 1/195 (0.5%) | ||
| Infective Exacerbation of Bronchiectasis | 0/191 (0%) | 1/195 (0.5%) | ||
| Intervertebral Discitis | 0/191 (0%) | 1/195 (0.5%) | ||
| Lower Respiratory Tract Infection Bacterial | 0/191 (0%) | 1/195 (0.5%) | ||
| Lymph Gland Infection | 0/191 (0%) | 1/195 (0.5%) | ||
| Meningitis Pneumococcal | 0/191 (0%) | 1/195 (0.5%) | ||
| Mycobacterium Avium Complex Infection | 0/191 (0%) | 1/195 (0.5%) | ||
| Osteomyelitis | 0/191 (0%) | 1/195 (0.5%) | ||
| Otitis Externa | 0/191 (0%) | 1/195 (0.5%) | ||
| Otitis Media | 0/191 (0%) | 1/195 (0.5%) | ||
| Parainfluenzae Virus Infection | 0/191 (0%) | 1/195 (0.5%) | ||
| Pneumococcal Sepsis | 0/191 (0%) | 1/195 (0.5%) | ||
| Pneumocystis Jirovecii Infection | 0/191 (0%) | 1/195 (0.5%) | ||
| Pneumonia Bacterial | 1/191 (0.5%) | 1/195 (0.5%) | ||
| Pneumonia Respiratory Syncytial Viral | 0/191 (0%) | 1/195 (0.5%) | ||
| Pneumonia viral | 0/191 (0%) | 1/195 (0.5%) | ||
| Pseudomonal Sepsis | 0/191 (0%) | 1/195 (0.5%) | ||
| Pseudomonas Infection | 2/191 (1%) | 1/195 (0.5%) | ||
| Pyelonephritis | 0/191 (0%) | 1/195 (0.5%) | ||
| Respiratory Tract Infection | 2/191 (1%) | 1/195 (0.5%) | ||
| Rhinovirus Infection | 0/191 (0%) | 1/195 (0.5%) | ||
| Septic Shock | 1/191 (0.5%) | 1/195 (0.5%) | ||
| Staphylococcal Sepsis | 0/191 (0%) | 1/195 (0.5%) | ||
| Staphylococcal Skin Infection | 0/191 (0%) | 1/195 (0.5%) | ||
| Tonsillitis Fungal | 0/191 (0%) | 1/195 (0.5%) | ||
| Tooth Infection | 0/191 (0%) | 1/195 (0.5%) | ||
| Urethritis | 0/191 (0%) | 1/195 (0.5%) | ||
| Urinary Tract Infection Pseudomonal | 0/191 (0%) | 1/195 (0.5%) | ||
| Viral Pharyngitis | 0/191 (0%) | 1/195 (0.5%) | ||
| Abscess Limb | 1/191 (0.5%) | 0/195 (0%) | ||
| Anal Infection | 1/191 (0.5%) | 0/195 (0%) | ||
| Breast Cellulitis | 1/191 (0.5%) | 0/195 (0%) | ||
| Febrile Infection | 1/191 (0.5%) | 0/195 (0%) | ||
| Herpes Simplex | 1/191 (0.5%) | 0/195 (0%) | ||
| Infectious Pleural Effusion | 1/191 (0.5%) | 0/195 (0%) | ||
| Lung Infection Pseudomonal | 1/191 (0.5%) | 0/195 (0%) | ||
| Nocardiosis | 1/191 (0.5%) | 0/195 (0%) | ||
| Ophthalmic Herpes Zoster | 1/191 (0.5%) | 0/195 (0%) | ||
| Pneumonia Mycoplasmal | 1/191 (0.5%) | 0/195 (0%) | ||
| Sepsis Syndrome | 1/191 (0.5%) | 0/195 (0%) | ||
| Stenotrophomonas Infection | 2/191 (1%) | 0/195 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Subdural Haematoma | 0/191 (0%) | 6/195 (3.1%) | ||
| Femur Fracture | 0/191 (0%) | 4/195 (2.1%) | ||
| Fall | 0/191 (0%) | 2/195 (1%) | ||
| Hip Fracture | 0/191 (0%) | 2/195 (1%) | ||
| Arthropod Bite | 0/191 (0%) | 1/195 (0.5%) | ||
| Brain Contusion | 0/191 (0%) | 1/195 (0.5%) | ||
| Burns Third Degree | 0/191 (0%) | 1/195 (0.5%) | ||
| Femoral Neck Fracture | 0/191 (0%) | 1/195 (0.5%) | ||
| Laceration | 0/191 (0%) | 1/195 (0.5%) | ||
| Multiple Fractures | 1/191 (0.5%) | 1/195 (0.5%) | ||
| Post Procedural Haemorrhage | 0/191 (0%) | 1/195 (0.5%) | ||
| Rib Fracture | 0/191 (0%) | 1/195 (0.5%) | ||
| Spinal Compression Fracture | 1/191 (0.5%) | 1/195 (0.5%) | ||
| Subarachnoid Haematoma | 0/191 (0%) | 1/195 (0.5%) | ||
| Subarachnoid Haemorrhage | 0/191 (0%) | 1/195 (0.5%) | ||
| Subdural Haemorrhage | 0/191 (0%) | 1/195 (0.5%) | ||
| Toxicity to Various Agents | 0/191 (0%) | 1/195 (0.5%) | ||
| Traumatic Haematoma | 0/191 (0%) | 1/195 (0.5%) | ||
| Infusion Related Reaction | 2/191 (1%) | 0/195 (0%) | ||
| Muscle Strain | 1/191 (0.5%) | 0/195 (0%) | ||
| Investigations | ||||
| Immunoglobulins Decreased | 0/191 (0%) | 1/195 (0.5%) | ||
| Metabolism and nutrition disorders | ||||
| Hyponatraemia | 0/191 (0%) | 3/195 (1.5%) | ||
| Hypercalcaemia | 0/191 (0%) | 2/195 (1%) | ||
| Dehydration | 0/191 (0%) | 1/195 (0.5%) | ||
| Hypokalaemia | 0/191 (0%) | 1/195 (0.5%) | ||
| Iron Deficiency | 0/191 (0%) | 1/195 (0.5%) | ||
| Tumour Lysis Syndrome | 1/191 (0.5%) | 1/195 (0.5%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back Pain | 0/191 (0%) | 4/195 (2.1%) | ||
| Arthritis | 0/191 (0%) | 2/195 (1%) | ||
| Pain in Extremity | 0/191 (0%) | 2/195 (1%) | ||
| Arthralgia | 0/191 (0%) | 1/195 (0.5%) | ||
| Bone Pain | 1/191 (0.5%) | 1/195 (0.5%) | ||
| Muscular Weakness | 0/191 (0%) | 1/195 (0.5%) | ||
| Myalgia | 0/191 (0%) | 1/195 (0.5%) | ||
| Pathological Fracture | 0/191 (0%) | 1/195 (0.5%) | ||
| Spinal Column Stenosis | 0/191 (0%) | 1/195 (0.5%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Chronic Lymphocytic Leukaemia | 3/191 (1.6%) | 5/195 (2.6%) | ||
| Basal Cell Carcinoma | 0/191 (0%) | 3/195 (1.5%) | ||
| Richter's Syndrome | 0/191 (0%) | 3/195 (1.5%) | ||
| Hodgkin's Disease | 0/191 (0%) | 2/195 (1%) | ||
| Lung Adenocarcinoma | 0/191 (0%) | 2/195 (1%) | ||
| Prostate Cancer | 0/191 (0%) | 2/195 (1%) | ||
| Adenocarcinoma | 0/191 (0%) | 1/195 (0.5%) | ||
| Bone Cancer Metastatic | 0/191 (0%) | 1/195 (0.5%) | ||
| Brain Neoplasm Malignant | 0/191 (0%) | 1/195 (0.5%) | ||
| Colon Adenoma | 0/191 (0%) | 1/195 (0.5%) | ||
| Colon Cancer | 0/191 (0%) | 1/195 (0.5%) | ||
| Desmoid Tumour | 0/191 (0%) | 1/195 (0.5%) | ||
| Gastrointestinal Carcinoma | 0/191 (0%) | 1/195 (0.5%) | ||
| Histiocytic Sarcoma | 0/191 (0%) | 1/195 (0.5%) | ||
| Intraductal Papillary Mucinous Neoplasm | 0/191 (0%) | 1/195 (0.5%) | ||
| Leukaemia | 0/191 (0%) | 1/195 (0.5%) | ||
| Myelodysplastic Syndrome | 0/191 (0%) | 1/195 (0.5%) | ||
| Squamous Cell Carcinoma | 1/191 (0.5%) | 1/195 (0.5%) | ||
| Squamous Cell Carcinoma of Lung | 0/191 (0%) | 1/195 (0.5%) | ||
| Tumour Flare | 0/191 (0%) | 1/195 (0.5%) | ||
| Metastatic Squamous Cell Carcinoma | 1/191 (0.5%) | 0/195 (0%) | ||
| Tumour Pain | 1/191 (0.5%) | 0/195 (0%) | ||
| Nervous system disorders | ||||
| Seizure | 0/191 (0%) | 3/195 (1.5%) | ||
| Cerebrovascular Accident | 0/191 (0%) | 2/195 (1%) | ||
| Transient Ischaemic Attack | 0/191 (0%) | 2/195 (1%) | ||
| Cerebral Haemorrhage | 0/191 (0%) | 1/195 (0.5%) | ||
| Dizziness | 0/191 (0%) | 1/195 (0.5%) | ||
| Encephalopathy | 0/191 (0%) | 1/195 (0.5%) | ||
| Sciatica | 0/191 (0%) | 1/195 (0.5%) | ||
| Syncope | 0/191 (0%) | 1/195 (0.5%) | ||
| Pregnancy, puerperium and perinatal conditions | ||||
| Pregnancy | 0/191 (0%) | 1/195 (0.5%) | ||
| Psychiatric disorders | ||||
| Mental Status Changes | 0/191 (0%) | 3/195 (1.5%) | ||
| Depression | 0/191 (0%) | 1/195 (0.5%) | ||
| Hallucination, Visual | 0/191 (0%) | 1/195 (0.5%) | ||
| Mania | 0/191 (0%) | 1/195 (0.5%) | ||
| Psychotic Disorder | 0/191 (0%) | 1/195 (0.5%) | ||
| Confusional State | 1/191 (0.5%) | 0/195 (0%) | ||
| Major Depression | 1/191 (0.5%) | 0/195 (0%) | ||
| Renal and urinary disorders | ||||
| Acute Kidney Injury | 2/191 (1%) | 4/195 (2.1%) | ||
| Haematuria | 0/191 (0%) | 2/195 (1%) | ||
| Urinary Retention | 0/191 (0%) | 2/195 (1%) | ||
| Calculus Bladder | 0/191 (0%) | 1/195 (0.5%) | ||
| Hydronephrosis | 0/191 (0%) | 1/195 (0.5%) | ||
| Ureterolithiasis | 0/191 (0%) | 1/195 (0.5%) | ||
| Renal Failure | 1/191 (0.5%) | 0/195 (0%) | ||
| Renal Impairment | 1/191 (0.5%) | 0/195 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute Respiratory Failure | 0/191 (0%) | 4/195 (2.1%) | ||
| Cough | 0/191 (0%) | 3/195 (1.5%) | ||
| Dyspnoea | 1/191 (0.5%) | 3/195 (1.5%) | ||
| Hypoxia | 0/191 (0%) | 2/195 (1%) | ||
| Pneumonia Aspiration | 0/191 (0%) | 2/195 (1%) | ||
| Asthma | 0/191 (0%) | 1/195 (0.5%) | ||
| Bronchopneumopathy | 0/191 (0%) | 1/195 (0.5%) | ||
| Chronic Obstructive Pulmonary Disease | 0/191 (0%) | 1/195 (0.5%) | ||
| Epistaxis | 1/191 (0.5%) | 1/195 (0.5%) | ||
| Lung Infiltration | 0/191 (0%) | 1/195 (0.5%) | ||
| Pleural Effusion | 0/191 (0%) | 1/195 (0.5%) | ||
| Haemoptysis | 1/191 (0.5%) | 0/195 (0%) | ||
| Pneumonitis | 1/191 (0.5%) | 0/195 (0%) | ||
| Pulmonary Embolism | 1/191 (0.5%) | 0/195 (0%) | ||
| Pulmonary Mass | 1/191 (0.5%) | 0/195 (0%) | ||
| Respiratory Tract Inflammation | 1/191 (0.5%) | 0/195 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Angioedema | 0/191 (0%) | 1/195 (0.5%) | ||
| Pyoderma Gangrenosum | 0/191 (0%) | 1/195 (0.5%) | ||
| Vascular disorders | ||||
| Hypertension | 0/191 (0%) | 2/195 (1%) | ||
| Aneurysm | 0/191 (0%) | 1/195 (0.5%) | ||
| Deep Vein Thrombosis | 1/191 (0.5%) | 0/195 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Ofatumumab (Arm A) | Ibrutinib (Arm B) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 185/191 (96.9%) | 194/195 (99.5%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 32/191 (16.8%) | 62/195 (31.8%) | ||
| Neutropenia | 25/191 (13.1%) | 60/195 (30.8%) | ||
| Increased Tendency to Bruise | 4/191 (2.1%) | 45/195 (23.1%) | ||
| Thrombocytopenia | 22/191 (11.5%) | 45/195 (23.1%) | ||
| Lymphocytosis | 5/191 (2.6%) | 10/195 (5.1%) | ||
| Cardiac disorders | ||||
| Atrial Fibrillation | 0/191 (0%) | 19/195 (9.7%) | ||
| Eye disorders | ||||
| Dry Eye | 10/191 (5.2%) | 33/195 (16.9%) | ||
| Vision Blurred | 6/191 (3.1%) | 30/195 (15.4%) | ||
| Lacrimation Increased | 5/191 (2.6%) | 27/195 (13.8%) | ||
| Cataract | 2/191 (1%) | 26/195 (13.3%) | ||
| Visual Acuity Reduced | 1/191 (0.5%) | 19/195 (9.7%) | ||
| Eye Irritation | 3/191 (1.6%) | 17/195 (8.7%) | ||
| Eye Pain | 5/191 (2.6%) | 15/195 (7.7%) | ||
| Photophobia | 4/191 (2.1%) | 14/195 (7.2%) | ||
| Vitreous Floaters | 3/191 (1.6%) | 14/195 (7.2%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 33/191 (17.3%) | 120/195 (61.5%) | ||
| Nausea | 38/191 (19.9%) | 69/195 (35.4%) | ||
| Constipation | 19/191 (9.9%) | 45/195 (23.1%) | ||
| Vomiting | 11/191 (5.8%) | 39/195 (20%) | ||
| Abdominal Pain | 19/191 (9.9%) | 30/195 (15.4%) | ||
| Stomatitis | 5/191 (2.6%) | 30/195 (15.4%) | ||
| Dyspepsia | 6/191 (3.1%) | 22/195 (11.3%) | ||
| Gastrooesophageal Reflux Disease | 3/191 (1.6%) | 21/195 (10.8%) | ||
| Dry Mouth | 1/191 (0.5%) | 19/195 (9.7%) | ||
| Abdominal Pain Upper | 3/191 (1.6%) | 16/195 (8.2%) | ||
| Flatulence | 2/191 (1%) | 10/195 (5.1%) | ||
| Haemorrhoids | 3/191 (1.6%) | 10/195 (5.1%) | ||
| General disorders | ||||
| Fatigue | 57/191 (29.8%) | 82/195 (42.1%) | ||
| Pyrexia | 27/191 (14.1%) | 66/195 (33.8%) | ||
| Oedema Peripheral | 16/191 (8.4%) | 46/195 (23.6%) | ||
| Asthenia | 8/191 (4.2%) | 22/195 (11.3%) | ||
| Chills | 6/191 (3.1%) | 16/195 (8.2%) | ||
| Influenza Like Illness | 5/191 (2.6%) | 16/195 (8.2%) | ||
| Malaise | 1/191 (0.5%) | 10/195 (5.1%) | ||
| Infections and infestations | ||||
| Upper Respiratory Tract Infection | 17/191 (8.9%) | 77/195 (39.5%) | ||
| Sinusitis | 12/191 (6.3%) | 50/195 (25.6%) | ||
| Urinary Tract Infection | 10/191 (5.2%) | 46/195 (23.6%) | ||
| Bronchitis | 2/191 (1%) | 28/195 (14.4%) | ||
| Nasopharyngitis | 7/191 (3.7%) | 22/195 (11.3%) | ||
| Conjunctivitis | 2/191 (1%) | 21/195 (10.8%) | ||
| Pneumonia | 3/191 (1.6%) | 21/195 (10.8%) | ||
| Cellulitis | 3/191 (1.6%) | 15/195 (7.7%) | ||
| Lower Respiratory Tract Infection | 0/191 (0%) | 15/195 (7.7%) | ||
| Herpes Zoster | 3/191 (1.6%) | 14/195 (7.2%) | ||
| Ear Infection | 2/191 (1%) | 13/195 (6.7%) | ||
| Folliculitis | 0/191 (0%) | 10/195 (5.1%) | ||
| Injury, poisoning and procedural complications | ||||
| Contusion | 6/191 (3.1%) | 38/195 (19.5%) | ||
| Fall | 1/191 (0.5%) | 18/195 (9.2%) | ||
| Traumatic Haematoma | 0/191 (0%) | 12/195 (6.2%) | ||
| Infusion Related Reaction | 64/191 (33.5%) | 0/195 (0%) | ||
| Investigations | ||||
| Weight Decreased | 11/191 (5.8%) | 25/195 (12.8%) | ||
| Blood Creatinine Increased | 0/191 (0%) | 12/195 (6.2%) | ||
| Platelet Count Decreased | 0/191 (0%) | 11/195 (5.6%) | ||
| Weight Increased | 0/191 (0%) | 11/195 (5.6%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased Appetite | 16/191 (8.4%) | 32/195 (16.4%) | ||
| Hyperuricaemia | 4/191 (2.1%) | 22/195 (11.3%) | ||
| Hypokalaemia | 5/191 (2.6%) | 22/195 (11.3%) | ||
| Hyperglycaemia | 6/191 (3.1%) | 16/195 (8.2%) | ||
| Hyponatraemia | 3/191 (1.6%) | 12/195 (6.2%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 14/191 (7.3%) | 53/195 (27.2%) | ||
| Muscle Spasms | 16/191 (8.4%) | 46/195 (23.6%) | ||
| Back Pain | 14/191 (7.3%) | 39/195 (20%) | ||
| Pain in Extremity | 9/191 (4.7%) | 29/195 (14.9%) | ||
| Myalgia | 7/191 (3.7%) | 24/195 (12.3%) | ||
| Musculoskeletal Pain | 9/191 (4.7%) | 20/195 (10.3%) | ||
| Bone Pain | 3/191 (1.6%) | 10/195 (5.1%) | ||
| Muscular Weakness | 3/191 (1.6%) | 10/195 (5.1%) | ||
| Neck Pain | 0/191 (0%) | 10/195 (5.1%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Basal Cell Carcinoma | 2/191 (1%) | 18/195 (9.2%) | ||
| Squamous Cell Carcinoma | 2/191 (1%) | 13/195 (6.7%) | ||
| Nervous system disorders | ||||
| Headache | 12/191 (6.3%) | 41/195 (21%) | ||
| Dizziness | 10/191 (5.2%) | 33/195 (16.9%) | ||
| Peripheral Sensory Neuropathy | 26/191 (13.6%) | 22/195 (11.3%) | ||
| Paraesthesia | 10/191 (5.2%) | 14/195 (7.2%) | ||
| Psychiatric disorders | ||||
| Anxiety | 9/191 (4.7%) | 18/195 (9.2%) | ||
| Depression | 3/191 (1.6%) | 17/195 (8.7%) | ||
| Insomnia | 16/191 (8.4%) | 17/195 (8.7%) | ||
| Confusional State | 4/191 (2.1%) | 11/195 (5.6%) | ||
| Renal and urinary disorders | ||||
| Pollakiuria | 3/191 (1.6%) | 19/195 (9.7%) | ||
| Dysuria | 1/191 (0.5%) | 12/195 (6.2%) | ||
| Haematuria | 2/191 (1%) | 12/195 (6.2%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 43/191 (22.5%) | 78/195 (40%) | ||
| Oropharyngeal pain | 9/191 (4.7%) | 33/195 (16.9%) | ||
| Dyspnoea | 18/191 (9.4%) | 32/195 (16.4%) | ||
| Epistaxis | 5/191 (2.6%) | 30/195 (15.4%) | ||
| Rhinorrhoea | 6/191 (3.1%) | 19/195 (9.7%) | ||
| Nasal Congestion | 6/191 (3.1%) | 17/195 (8.7%) | ||
| Dyspnoea Exertional | 4/191 (2.1%) | 14/195 (7.2%) | ||
| Productive Cough | 5/191 (2.6%) | 14/195 (7.2%) | ||
| Dysphonia | 0/191 (0%) | 10/195 (5.1%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Petechiae | 2/191 (1%) | 28/195 (14.4%) | ||
| Rash Maculo-Papular | 7/191 (3.7%) | 26/195 (13.3%) | ||
| Night Sweats | 23/191 (12%) | 24/195 (12.3%) | ||
| Skin Lesion | 5/191 (2.6%) | 24/195 (12.3%) | ||
| Rash Erythematous | 9/191 (4.7%) | 20/195 (10.3%) | ||
| Pruritus | 18/191 (9.4%) | 19/195 (9.7%) | ||
| Rash | 7/191 (3.7%) | 19/195 (9.7%) | ||
| Dry Skin | 3/191 (1.6%) | 18/195 (9.2%) | ||
| Actinic Keratosis | 5/191 (2.6%) | 16/195 (8.2%) | ||
| Ecchymosis | 0/191 (0%) | 12/195 (6.2%) | ||
| Onychoclasis | 0/191 (0%) | 12/195 (6.2%) | ||
| Blood Blister | 1/191 (0.5%) | 10/195 (5.1%) | ||
| Skin Ulcer | 0/191 (0%) | 10/195 (5.1%) | ||
| Vascular disorders | ||||
| Hypertension | 4/191 (2.1%) | 40/195 (20.5%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Anita Szoke |
|---|---|
| Organization | Pharmacyclics, LLC |
| Phone | (669) 215-7235 |
| aszoke@pcyc.com |
Responsible Party:
Pharmacyclics LLC.
ClinicalTrials.gov Identifier:
NCT01578707
Other Study ID Numbers:
- PCYC-1112-CA
- 2012-000694-23
First Posted:
Apr 17, 2012
Last Update Posted:
Dec 18, 2019
Last Verified:
Dec 1, 2019