Trial Outcomes & Findings for Study of Ibrutinib in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed/Relapsed and Refractory Multiple Myeloma (NCT NCT02902965)
NCT ID: NCT02902965
Last Updated: 2020-03-16
Results Overview
The primary efficacy endpoint of this study is mPFS. Progression free survival is defined as the time from the date of first dose of study treatment to confirmed disease progression or death from any cause, whichever occurs first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
The median time on study was 19.6 months (range: 0.16+, 24.64). Participants were evaluated for Progression-Free Survival (PFS) during their entire time on the study.
Results posted on
2020-03-16
Participant Flow
Participant milestones
| Measure |
Ibrutinib+ Bortezomib+ Dexamethasone
Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects \>75 years of age.
Following implementation of Protocol Amendment4, D administration was reduced to Days 1, 4, 8, and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter
|
|---|---|
|
Overall Study
STARTED
|
74
|
|
Overall Study
COMPLETED
|
64
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Ibrutinib+ Bortezomib+ Dexamethasone
Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects \>75 years of age.
Following implementation of Protocol Amendment4, D administration was reduced to Days 1, 4, 8, and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter
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|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
Baseline Characteristics
Study of Ibrutinib in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed/Relapsed and Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Ibrutinib+ Bortezomib+ Dexamethasone
n=74 Participants
Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone(D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects \>75 years of age.
Following implementation of Protocol Amendment 4, D administration was reduced to Days 1, 4, 8 and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter.
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
45 Participants
n=5 Participants
|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 10.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
71 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
23 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The median time on study was 19.6 months (range: 0.16+, 24.64). Participants were evaluated for Progression-Free Survival (PFS) during their entire time on the study.Population: All participant received: see description on Arm/Group description. Following implementation of Amendment 4, dexamethasone administration was reduced to Days 1, 4, 8 and 11 during each 21-day cycle (Cycles 1-8) and on Days 1, 8, 22 and 29 on each 42-day cycle (Cycles 9-12) and unchanged thereafter.
The primary efficacy endpoint of this study is mPFS. Progression free survival is defined as the time from the date of first dose of study treatment to confirmed disease progression or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Ibrutinib+ Bortezomib+ Dexamethasone
n=74 Participants
Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects \>75 years of age.
Following implementation of Protocol Amendment 4, D administration was reduced to Days 1, 4, 8, and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter
|
|---|---|
|
Median Progression-Free Survival (PFS)
|
8.5 Months
Interval 6.2 to 10.8
|
SECONDARY outcome
Timeframe: The median time on study was 19.6 months (range: 0.16+, 24.64). Participants were evaluated for Overall Response (OR) during the entire time on the study.Overall Response Rate is the percentage of participants who achieve a PR or better over the course of the study but prior to initiation of subsequent anti-cancer therapy
Outcome measures
| Measure |
Ibrutinib+ Bortezomib+ Dexamethasone
n=74 Participants
Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects \>75 years of age.
Following implementation of Protocol Amendment 4, D administration was reduced to Days 1, 4, 8, and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter
|
|---|---|
|
Overall Response Rate (ORR)
|
56.8 percentage of participants
Interval 44.7 to 68.2
|
SECONDARY outcome
Timeframe: The median time on study was 19.6 months (range: 0.16+, 24.64), with the 20 month Progression-Free Survival (PFS) rate presented based on Kaplan-Meier estimates.PFS at landmark points are the percentage of participants without progression (i.e., KM estimates) at the landmark time endpoints.
Outcome measures
| Measure |
Ibrutinib+ Bortezomib+ Dexamethasone
n=74 Participants
Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects \>75 years of age.
Following implementation of Protocol Amendment 4, D administration was reduced to Days 1, 4, 8, and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter
|
|---|---|
|
Progression Free Survival (PFS) at Landmark Points - 20 Months
|
6.6 percentage of participants
Interval 1.6 to 16.9
|
SECONDARY outcome
Timeframe: The median time on study was 19.6 months (range: 0.16+, 24.64).The time interval between the date of initial documentation of a response (PR or better) and the date of first documented evidence of PD, death, or date of censoring for the participants not progressed/died. The censoring date is the last adequate tumor assessment date.
Outcome measures
| Measure |
Ibrutinib+ Bortezomib+ Dexamethasone
n=74 Participants
Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects \>75 years of age.
Following implementation of Protocol Amendment 4, D administration was reduced to Days 1, 4, 8, and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter
|
|---|---|
|
Duration of Response (DOR)
|
9.5 Months
Interval 6.9 to 10.6
|
SECONDARY outcome
Timeframe: The median time on study was 19.6 months (0.16+, 24.64), with the 24 month Overall Survival (OS) rate presented based on Kaplan-Meier estimates.As the median overall survival has not been reached, the data for the landmark analysis at 24 months are provided.
Outcome measures
| Measure |
Ibrutinib+ Bortezomib+ Dexamethasone
n=74 Participants
Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects \>75 years of age.
Following implementation of Protocol Amendment 4, D administration was reduced to Days 1, 4, 8, and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter
|
|---|---|
|
Overall Survival (OS) at 24 Months
|
53.6 percentage of participants
Interval 38.0 to 67.0
|
SECONDARY outcome
Timeframe: The median time on study was 19.6 months (range: 0.16+, 24.64).Time from date of first dose of study treatment to the date of first documented evidence of PD or date of censoring for the participants not progressed. The censoring date is the last adequate tumor assessment date.
Outcome measures
| Measure |
Ibrutinib+ Bortezomib+ Dexamethasone
n=74 Participants
Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects \>75 years of age.
Following implementation of Protocol Amendment 4, D administration was reduced to Days 1, 4, 8, and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter
|
|---|---|
|
Time to Progression (TTP)
|
10.6 Months
Interval 7.8 to 12.0
|
SECONDARY outcome
Timeframe: From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).Population: Safety population
Safety and tolerability of ibrutinib in combination with bortezomib and dexamethasone as measured by the frequency and type of adverse events graded using the NCI CTCAE v 4.03. Frequency and Type of Adverse Events are reported in the Adverse Events module
Outcome measures
| Measure |
Ibrutinib+ Bortezomib+ Dexamethasone
n=74 Participants
Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects \>75 years of age.
Following implementation of Protocol Amendment 4, D administration was reduced to Days 1, 4, 8, and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter
|
|---|---|
|
Safety and Tolerability of Ibrutinib in Combination With Bortezomib and Dexamethasone as Measured by the Number of Participants With Adverse Events.
|
74 Participants
|
Adverse Events
Ibrutinib+ Bortezomib+ Dexamethasone
Serious events: 47 serious events
Other events: 74 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Ibrutinib+ Bortezomib+ Dexamethasone
n=74 participants at risk
Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects \>75 years of age.
Following implementation of Protocol Amendment 4, D administration was reduced to Days 1, 4, 8 and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter.
|
|---|---|
|
Vascular disorders
Circulatory collapse
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
General disorders
Asthenia
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
General disorders
Death
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
General disorders
Pyrexia
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
General disorders
Sudden death
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Psychiatric disorders
Delirium
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Investigations
Weight decreased
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Cardiac disorders
Atrial fibrillation
|
4.1%
3/74 • Number of events 3 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Cardiac disorders
Atrial flutter
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Cardiac disorders
Sinus bradycardia
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.7%
2/74 • Number of events 7 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Nervous system disorders
Polyneuropathy
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Nervous system disorders
Syncope
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Renal and urinary disorders
Renal failure
|
2.7%
2/74 • Number of events 2 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Renal and urinary disorders
Renal impairment
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Hepatobiliary disorders
Cholangitis acute
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Metabolism and nutrition disorders
Decrease appetite
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.7%
2/74 • Number of events 2 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Atypical pneumonia
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Bacteraemia
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Brain abscess
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Bronchitis
|
2.7%
2/74 • Number of events 2 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Bronchitis viral
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Erysipelas
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Gastroenteritis
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Gastrointestinal infection
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Haemophilus bacteraemia
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Haemophilus infection
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Herpes simplex
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Infection
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Influenza
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Lung infection
|
2.7%
2/74 • Number of events 2 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Pneumococcal sepsis
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Pneumonia
|
14.9%
11/74 • Number of events 12 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Pneumonia bacterial
|
2.7%
2/74 • Number of events 2 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Pneumonia escherichia
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Pneumonia haemophilus
|
2.7%
2/74 • Number of events 2 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Pneumonia pneumococcal
|
2.7%
2/74 • Number of events 2 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Pseudomonal sepsis
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Respiratory tract infection
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Salmonellosis
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Sepsis
|
4.1%
3/74 • Number of events 4 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Staphylococcal infection
|
1.4%
1/74 • Number of events 1 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
2/74 • Number of events 2 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
4.1%
3/74 • Number of events 3 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
Other adverse events
| Measure |
Ibrutinib+ Bortezomib+ Dexamethasone
n=74 participants at risk
Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects \>75 years of age.
Following implementation of Protocol Amendment 4, D administration was reduced to Days 1, 4, 8 and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter.
|
|---|---|
|
Vascular disorders
Hypertension
|
13.5%
10/74 • Number of events 14 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Vascular disorders
Hypotension
|
10.8%
8/74 • Number of events 9 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
General disorders
Asthenia
|
29.7%
22/74 • Number of events 60 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
General disorders
Fatigue
|
28.4%
21/74 • Number of events 40 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
General disorders
Oedema peripheral
|
28.4%
21/74 • Number of events 29 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
General disorders
Pain
|
4.1%
3/74 • Number of events 3 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
General disorders
Peripheral swelling
|
6.8%
5/74 • Number of events 6 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
General disorders
Pyrexia
|
17.6%
13/74 • Number of events 18 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Psychiatric disorders
Depression
|
4.1%
3/74 • Number of events 3 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Psychiatric disorders
Insomnia
|
8.1%
6/74 • Number of events 6 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Investigations
Blood creatinine increased
|
5.4%
4/74 • Number of events 6 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Investigations
Weight decreased
|
5.4%
4/74 • Number of events 5 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Cardiac disorders
Atrial fibrillation
|
8.1%
6/74 • Number of events 7 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Blood and lymphatic system disorders
Anaemia
|
37.8%
28/74 • Number of events 66 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
14.9%
11/74 • Number of events 50 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.5%
10/74 • Number of events 20 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
60.8%
45/74 • Number of events 293 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.3%
15/74 • Number of events 20 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.8%
8/74 • Number of events 11 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.5%
7/74 • Number of events 8 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.8%
5/74 • Number of events 6 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.4%
4/74 • Number of events 4 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Nervous system disorders
Dizziness
|
6.8%
5/74 • Number of events 6 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Nervous system disorders
Headache
|
8.1%
6/74 • Number of events 6 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.4%
4/74 • Number of events 6 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
6.8%
5/74 • Number of events 14 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Nervous system disorders
Periperal sensory neuropathy
|
24.3%
18/74 • Number of events 19 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Nervous system disorders
Polyneuropathy
|
6.8%
5/74 • Number of events 10 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Nervous system disorders
Somnolence
|
5.4%
4/74 • Number of events 6 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Nervous system disorders
Syncope
|
5.4%
4/74 • Number of events 4 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Eye disorders
Lacrimation increased
|
5.4%
4/74 • Number of events 5 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Eye disorders
Vision blurred
|
5.4%
4/74 • Number of events 4 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Ear and labyrinth disorders
Vertigo
|
4.1%
3/74 • Number of events 4 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.8%
5/74 • Number of events 8 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.1%
6/74 • Number of events 7 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Gastrointestinal disorders
Constipation
|
13.5%
10/74 • Number of events 17 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Gastrointestinal disorders
Diarrhoea
|
54.1%
40/74 • Number of events 119 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.8%
5/74 • Number of events 5 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
4.1%
3/74 • Number of events 3 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Gastrointestinal disorders
Nausea
|
24.3%
18/74 • Number of events 24 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Gastrointestinal disorders
Stomatitis
|
5.4%
4/74 • Number of events 5 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Gastrointestinal disorders
Vomiting
|
14.9%
11/74 • Number of events 13 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Renal and urinary disorders
Renal impairment
|
4.1%
3/74 • Number of events 6 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
8.1%
6/74 • Number of events 22 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
6.8%
5/74 • Number of events 6 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
13.5%
10/74 • Number of events 15 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.3%
15/74 • Number of events 19 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.4%
4/74 • Number of events 5 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.8%
5/74 • Number of events 7 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.1%
3/74 • Number of events 3 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.1%
3/74 • Number of events 4 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.8%
5/74 • Number of events 6 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.1%
6/74 • Number of events 8 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Endocrine disorders
Cushingoid
|
5.4%
4/74 • Number of events 5 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.5%
10/74 • Number of events 11 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
4.1%
3/74 • Number of events 3 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.4%
4/74 • Number of events 4 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
17.6%
13/74 • Number of events 22 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
14.9%
11/74 • Number of events 16 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.4%
4/74 • Number of events 8 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.8%
5/74 • Number of events 10 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Investigations
Platelet count decreased
|
5.4%
4/74 • Number of events 16 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Bronchitis
|
12.2%
9/74 • Number of events 11 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Conjunctivitis
|
13.5%
10/74 • Number of events 11 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Herpes zoster
|
4.1%
3/74 • Number of events 4 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Infection
|
4.1%
3/74 • Number of events 3 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Influenza
|
4.1%
3/74 • Number of events 3 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Nasopharyngitis
|
13.5%
10/74 • Number of events 17 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Oral candidiasis
|
5.4%
4/74 • Number of events 4 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Pharyngitis
|
4.1%
3/74 • Number of events 3 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Pneumonia
|
6.8%
5/74 • Number of events 5 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Respiratory tract infection
|
9.5%
7/74 • Number of events 11 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Tonsillitis
|
4.1%
3/74 • Number of events 3 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.7%
19/74 • Number of events 29 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
|
Infections and infestations
Urinary tract infection
|
10.8%
8/74 • Number of events 9 • From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Number of participants who had experienced at least one treatment emergent AE.
|
Additional Information
Dr. Bernhard Hauns, Medical Monitor
Pharmacyclics Switzerland GmbH
Phone: +41 52 556 0800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place