Trial Outcomes & Findings for Study to Evaluate the Safety and Tolerability of Tirabrutinib (ONO/GS-4059) Given as Monotherapy in Participants With Relapsed/Refractory NHL and CLL (NCT NCT01659255)
NCT ID: NCT01659255
Last Updated: 2021-03-16
Results Overview
Dose Limiting Toxicities (DLT) were defined as follows: * All Common Terminology Criteria (CTC) Grade 4 tirabrutinib related adverse events * All CTC Grade 3 tirabrutinib related adverse events, with the exception of the following: * CTC Grade 3 lymphocytosis considered an expected outcome of therapy Any toxicity which in the opinion of the Investigator is attributed to a participant's underlying disease was not considered a DLT.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
90 participants
Primary outcome timeframe
Day 1 through Day 28
Results posted on
2021-03-16
Participant Flow
Participants were enrolled at study sites in Europe. The first participant was screened on 17 August 2012. The last study visit occurred on 11 January 2016.
102 participants were screened.
Participant milestones
| Measure |
Tirabrutinib 20 mg Once Daily (CLL)
Participants with relapsed/refractory chronic lymphocytic leukaemia (CLL) received tirabrutinib 20 mg once daily.
|
Tirabrutinib 40 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily.
|
Tirabrutinib 80 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily.
|
Tirabrutinib 160 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily.
|
Tirabrutinib 320 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily.
|
Tirabrutinib 400 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily.
|
Tirabrutinib 500 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily.
|
Tirabrutinib 600 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily.
|
Tirabrutinib 300 mg Twice Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily.
|
Tirabrutinib 20 mg Once Daily (NHL)
Participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) received tirabrutinib 20 mg once daily.
|
Tirabrutinib 40 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 40 mg once daily.
|
Tirabrutinib 80 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 80 mg once daily.
|
Tirabrutinib 160 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily.
|
Tirabrutinib 320 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily.
|
Tirabrutinib 480 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily.
|
Tirabrutinib 600 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily.
|
Tirabrutinib 240 mg Twice Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
4
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
5
|
8
|
21
|
10
|
9
|
3
|
|
Overall Study
COMPLETED
|
1
|
2
|
4
|
3
|
3
|
2
|
1
|
1
|
2
|
0
|
0
|
1
|
0
|
3
|
2
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
0
|
0
|
1
|
2
|
2
|
1
|
3
|
3
|
4
|
8
|
18
|
8
|
5
|
3
|
Reasons for withdrawal
| Measure |
Tirabrutinib 20 mg Once Daily (CLL)
Participants with relapsed/refractory chronic lymphocytic leukaemia (CLL) received tirabrutinib 20 mg once daily.
|
Tirabrutinib 40 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily.
|
Tirabrutinib 80 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily.
|
Tirabrutinib 160 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily.
|
Tirabrutinib 320 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily.
|
Tirabrutinib 400 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily.
|
Tirabrutinib 500 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily.
|
Tirabrutinib 600 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily.
|
Tirabrutinib 300 mg Twice Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily.
|
Tirabrutinib 20 mg Once Daily (NHL)
Participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) received tirabrutinib 20 mg once daily.
|
Tirabrutinib 40 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 40 mg once daily.
|
Tirabrutinib 80 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 80 mg once daily.
|
Tirabrutinib 160 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily.
|
Tirabrutinib 320 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily.
|
Tirabrutinib 480 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily.
|
Tirabrutinib 600 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily.
|
Tirabrutinib 240 mg Twice Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
0
|
1
|
0
|
2
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
1
|
1
|
2
|
1
|
0
|
|
Overall Study
Progressive Disease
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
2
|
3
|
5
|
13
|
6
|
2
|
3
|
|
Overall Study
Withdrew Consent
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Investigator Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Sponsor's Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Completed Treatment Per Protocol at the Time
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Participant Went on to Have an Allograft
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study to Evaluate the Safety and Tolerability of Tirabrutinib (ONO/GS-4059) Given as Monotherapy in Participants With Relapsed/Refractory NHL and CLL
Baseline characteristics by cohort
| Measure |
Tirabrutinib 20 mg Once Daily (CLL)
n=3 Participants
Participants with relapsed/refractory CLL received tirabrutinib 20 mg once daily.
|
Tirabrutinib 40 mg Once Daily (CLL)
n=3 Participants
Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily.
|
Tirabrutinib 80 mg Once Daily (CLL)
n=4 Participants
Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily.
|
Tirabrutinib 160 mg Once Daily (CLL)
n=3 Participants
Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily.
|
Tirabrutinib 320 mg Once Daily (CLL)
n=3 Participants
Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily.
|
Tirabrutinib 400 mg Once Daily (CLL)
n=3 Participants
Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily.
|
Tirabrutinib 500 mg Once Daily (CLL)
n=3 Participants
Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily.
|
Tirabrutinib 600 mg Once Daily (CLL)
n=3 Participants
Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily.
|
Tirabrutinib 300 mg Twice Daily (CLL)
n=3 Participants
Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily.
|
Tirabrutinib 20 mg Once Daily (NHL)
n=3 Participants
Participants with relapsed/refractory NHL received tirabrutinib 20 mg once daily.
|
Tirabrutinib 40 mg Once Daily (NHL)
n=3 Participants
Participants with relapsed/refractory NHL received tirabrutinib 40 mg once daily.
|
Tirabrutinib 80 mg Once Daily (NHL)
n=5 Participants
Participants with relapsed/refractory NHL received tirabrutinib 80 mg once daily.
|
Tirabrutinib 160 mg Once Daily (NHL)
n=8 Participants
Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily.
|
Tirabrutinib 320 mg Once Daily (NHL)
n=21 Participants
Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily.
|
Tirabrutinib 480 mg Once Daily (NHL)
n=10 Participants
Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily.
|
Tirabrutinib 600 mg Once Daily (NHL)
n=9 Participants
Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily.
|
Tirabrutinib 240 mg Twice Daily (NHL)
n=3 Participants
Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
< 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
7 Participants
n=36 Participants
|
7 Participants
n=36 Participants
|
6 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
39 Participants
n=44 Participants
|
|
Age, Customized
≥ 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
14 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
7 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
51 Participants
n=44 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
8 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
25 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
7 Participants
n=36 Participants
|
13 Participants
n=36 Participants
|
7 Participants
n=24 Participants
|
6 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
65 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
7 Participants
n=36 Participants
|
16 Participants
n=36 Participants
|
9 Participants
n=24 Participants
|
8 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
75 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
13 Participants
n=44 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 28Population: The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data for DLTs were summarized by dose level received by participants with NHL and CLL.
Dose Limiting Toxicities (DLT) were defined as follows: * All Common Terminology Criteria (CTC) Grade 4 tirabrutinib related adverse events * All CTC Grade 3 tirabrutinib related adverse events, with the exception of the following: * CTC Grade 3 lymphocytosis considered an expected outcome of therapy Any toxicity which in the opinion of the Investigator is attributed to a participant's underlying disease was not considered a DLT.
Outcome measures
| Measure |
Tirabrutinib 20 mg Once Daily (CLL)
n=3 Participants
Participants with relapsed/refractory CLL received tirabrutinib 20 mg once daily.
|
Tirabrutinib 40 mg Once Daily (CLL)
n=3 Participants
Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily.
|
Tirabrutinib 80 mg Once Daily (CLL)
n=4 Participants
Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily.
|
Tirabrutinib 160 mg Once Daily (CLL)
n=3 Participants
Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily.
|
Tirabrutinib 320 mg Once Daily (CLL)
n=3 Participants
Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily.
|
Tirabrutinib 400 mg Once Daily (CLL)
n=3 Participants
Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily.
|
Tirabrutinib 500 mg Once Daily (CLL)
n=3 Participants
Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily.
|
Tirabrutinib 600 mg Once Daily (CLL)
n=3 Participants
Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily.
|
Tirabrutinib 300 mg Twice Daily (CLL)
n=3 Participants
Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily.
|
Tirabrutinib 20 mg Once Daily (NHL)
n=3 Participants
Participants with relapsed/refractory NHL received tirabrutinib 20 mg once daily.
|
Tirabrutinib 40 mg Once Daily (NHL)
n=3 Participants
Participants with relapsed/refractory NHL received tirabrutinib 40 mg once daily.
|
Tirabrutinib 80 mg Once Daily (NHL)
n=5 Participants
Participants with relapsed/refractory NHL received tirabrutinib 80 mg once daily.
|
Tirabrutinib 160 mg Once Daily (NHL)
n=8 Participants
Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily.
|
Tirabrutinib 320 mg Once Daily (NHL)
n=21 Participants
Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily.
|
Tirabrutinib 480 mg Once Daily (NHL)
n=10 Participants
Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily.
|
Tirabrutinib 600 mg Once Daily (NHL)
n=9 Participants
Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily.
|
Tirabrutinib 240 mg Twice Daily (NHL)
n=3 Participants
Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Dose-Limiting Toxicities
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
33.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
33.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
4.8 percentage of participants
|
10.0 percentage of participants
|
22.2 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Cycle 37 (28 days for each cycle) plus 6-month intervals thereafter until disease progression (maximum: up to 39 months)Population: The Full Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data for overall response rate were summarized by overall CLL group and NHL subgroup.
Overall response rate (ORR) was defined as the percentage of participants who achieve a best overall response of complete remission (CR, unconfirmed complete response (CRu), complete response with incomplete marrow recovery (CRi)) or partial remission (PR, nodal PR) during study as assessed by the investigator. ORR assessment was defined per following standardized criteria: * NHL: Cheson, 1999 * CLL: International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008
Outcome measures
| Measure |
Tirabrutinib 20 mg Once Daily (CLL)
n=28 Participants
Participants with relapsed/refractory CLL received tirabrutinib 20 mg once daily.
|
Tirabrutinib 40 mg Once Daily (CLL)
n=5 Participants
Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily.
|
Tirabrutinib 80 mg Once Daily (CLL)
n=1 Participants
Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily.
|
Tirabrutinib 160 mg Once Daily (CLL)
n=3 Participants
Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily.
|
Tirabrutinib 320 mg Once Daily (CLL)
n=2 Participants
Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily.
|
Tirabrutinib 400 mg Once Daily (CLL)
n=35 Participants
Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily.
|
Tirabrutinib 500 mg Once Daily (CLL)
n=16 Participants
Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily.
|
Tirabrutinib 600 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily.
|
Tirabrutinib 300 mg Twice Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily.
|
Tirabrutinib 20 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 20 mg once daily.
|
Tirabrutinib 40 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 40 mg once daily.
|
Tirabrutinib 80 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 80 mg once daily.
|
Tirabrutinib 160 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily.
|
Tirabrutinib 320 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily.
|
Tirabrutinib 480 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily.
|
Tirabrutinib 600 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily.
|
Tirabrutinib 240 mg Twice Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate
|
85.7 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
31.4 percentage of participants
|
68.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, then 30 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose at Cycle 1, Day 28Population: Participants in the PK Analysis Set (all participants who received at least 1 dose of study drug and had at least 1 nonmissing postdose concentration value for the corresponding analyte in plasma) with available data were analyzed. Per planned analysis, data for PK parameters were summarized by dose cohorts.
Cmax is defined as the maximum concentration of drug.
Outcome measures
| Measure |
Tirabrutinib 20 mg Once Daily (CLL)
n=6 Participants
Participants with relapsed/refractory CLL received tirabrutinib 20 mg once daily.
|
Tirabrutinib 40 mg Once Daily (CLL)
n=6 Participants
Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily.
|
Tirabrutinib 80 mg Once Daily (CLL)
n=5 Participants
Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily.
|
Tirabrutinib 160 mg Once Daily (CLL)
n=10 Participants
Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily.
|
Tirabrutinib 320 mg Once Daily (CLL)
n=17 Participants
Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily.
|
Tirabrutinib 400 mg Once Daily (CLL)
n=2 Participants
Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily.
|
Tirabrutinib 500 mg Once Daily (CLL)
n=7 Participants
Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily.
|
Tirabrutinib 600 mg Once Daily (CLL)
n=3 Participants
Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily.
|
Tirabrutinib 300 mg Twice Daily (CLL)
n=6 Participants
Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily.
|
Tirabrutinib 20 mg Once Daily (NHL)
n=3 Participants
Participants with relapsed/refractory NHL received tirabrutinib 20 mg once daily.
|
Tirabrutinib 40 mg Once Daily (NHL)
n=3 Participants
Participants with relapsed/refractory NHL received tirabrutinib 40 mg once daily.
|
Tirabrutinib 80 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 80 mg once daily.
|
Tirabrutinib 160 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily.
|
Tirabrutinib 320 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily.
|
Tirabrutinib 480 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily.
|
Tirabrutinib 600 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily.
|
Tirabrutinib 240 mg Twice Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: Cmax of Tirabrutinib
|
73.4 ng/mL
Standard Deviation 18.26
|
164.5 ng/mL
Standard Deviation 47.22
|
241 ng/mL
Standard Deviation 90.68
|
539.6 ng/mL
Standard Deviation 141.58
|
1181.6 ng/mL
Standard Deviation 380.39
|
826.5 ng/mL
Standard Deviation 499.92
|
1240.3 ng/mL
Standard Deviation 516.99
|
1230 ng/mL
Standard Deviation 285.83
|
1265.2 ng/mL
Standard Deviation 486.21
|
704.3 ng/mL
Standard Deviation 254.51
|
674.3 ng/mL
Standard Deviation 93.78
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, then 30 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose at Cycle 1, Day 28Population: Participants in the PK Analysis Set with available data were analyzed. Per planned analysis, data for PK parameters were summarized by dose cohorts.
AUCtau is defined as concentration of drug over dosing interval.
Outcome measures
| Measure |
Tirabrutinib 20 mg Once Daily (CLL)
n=6 Participants
Participants with relapsed/refractory CLL received tirabrutinib 20 mg once daily.
|
Tirabrutinib 40 mg Once Daily (CLL)
n=6 Participants
Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily.
|
Tirabrutinib 80 mg Once Daily (CLL)
n=5 Participants
Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily.
|
Tirabrutinib 160 mg Once Daily (CLL)
n=10 Participants
Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily.
|
Tirabrutinib 320 mg Once Daily (CLL)
n=17 Participants
Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily.
|
Tirabrutinib 400 mg Once Daily (CLL)
n=2 Participants
Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily.
|
Tirabrutinib 500 mg Once Daily (CLL)
n=7 Participants
Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily.
|
Tirabrutinib 600 mg Once Daily (CLL)
n=3 Participants
Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily.
|
Tirabrutinib 300 mg Twice Daily (CLL)
n=5 Participants
Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily.
|
Tirabrutinib 20 mg Once Daily (NHL)
n=3 Participants
Participants with relapsed/refractory NHL received tirabrutinib 20 mg once daily.
|
Tirabrutinib 40 mg Once Daily (NHL)
n=2 Participants
Participants with relapsed/refractory NHL received tirabrutinib 40 mg once daily.
|
Tirabrutinib 80 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 80 mg once daily.
|
Tirabrutinib 160 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily.
|
Tirabrutinib 320 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily.
|
Tirabrutinib 480 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily.
|
Tirabrutinib 600 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily.
|
Tirabrutinib 240 mg Twice Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter: AUCtau of Tirabrutinib
|
306.4 h*ng/mL
Standard Deviation 74.92
|
660.1 h*ng/mL
Standard Deviation 310.95
|
762 h*ng/mL
Standard Deviation 374.94
|
2681.8 h*ng/mL
Standard Deviation 1055.17
|
5664.8 h*ng/mL
Standard Deviation 1829.07
|
5259.5 h*ng/mL
Standard Deviation 3166.57
|
7999.8 h*ng/mL
Standard Deviation 2006.19
|
6766.9 h*ng/mL
Standard Deviation 1025.64
|
8442.2 h*ng/mL
Standard Deviation 2499.22
|
3415.5 h*ng/mL
Standard Deviation 1296.47
|
3297.2 h*ng/mL
Standard Deviation 1330
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Chronic Lymphocytic Leukaemia
Serious events: 17 serious events
Other events: 28 other events
Deaths: 5 deaths
Non-Hodgkin's Lymphoma
Serious events: 23 serious events
Other events: 55 other events
Deaths: 38 deaths
Serious adverse events
| Measure |
Chronic Lymphocytic Leukaemia
n=28 participants at risk
Participants with relapsed/refractory CLL received tirabrutinib until disease progression or until the participant entered into a possible future tirabrutinib study.
|
Non-Hodgkin's Lymphoma
n=62 participants at risk
Participants with relapsed/refractory NHL received tirabrutinib until disease progression or until the participant entered into a possible future tirabrutinib study.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Purpura
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Blood and lymphatic system disorders
Lymphocytic infiltration
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
General disorders
General physical health deterioration
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
General disorders
Ill-defined disorder
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
General disorders
Pyrexia
|
10.7%
3/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Abdominal abscess
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Bacteraemia
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Bronchiolitis
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Bronchitis
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Device related infection
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Ear infection
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Escherichia sepsis
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
H1n1 influenza
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Hepatitis E
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Herpes zoster oticus
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Infection
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Influenza
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Lower respiratory tract infection
|
14.3%
4/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
4.8%
3/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Lower respiratory tract infection fungal
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Lung infection
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Neutropenic infection
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Neutropenic sepsis
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
3.2%
2/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Pneumonia
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
3.2%
2/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Pneumonia pneumococcal
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Respiratory tract infection viral
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Sepsis
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Injury, poisoning and procedural complications
Cardiac function disturbance postoperative
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Nervous system disorders
Dysarthria
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Nervous system disorders
Paraesthesia
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Nervous system disorders
Seizure
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Nervous system disorders
Syncope
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Psychiatric disorders
Anxiety
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Psychiatric disorders
Disorientation
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Renal and urinary disorders
Calculus ureteric
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Renal and urinary disorders
Myeloma cast nephropathy
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
Other adverse events
| Measure |
Chronic Lymphocytic Leukaemia
n=28 participants at risk
Participants with relapsed/refractory CLL received tirabrutinib until disease progression or until the participant entered into a possible future tirabrutinib study.
|
Non-Hodgkin's Lymphoma
n=62 participants at risk
Participants with relapsed/refractory NHL received tirabrutinib until disease progression or until the participant entered into a possible future tirabrutinib study.
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
8.1%
5/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Blood and lymphatic system disorders
Anaemia
|
32.1%
9/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
37.1%
23/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
3.2%
2/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
19.4%
12/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
32.1%
9/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
14.5%
9/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
4/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
29.0%
18/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Ear and labyrinth disorders
Ear pain
|
10.7%
3/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Eye disorders
Conjunctival haemorrhage
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Eye disorders
Eye haemorrhage
|
10.7%
3/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Eye disorders
Eye pruritus
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
3.2%
2/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Eye disorders
Glaucoma
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Eye disorders
Ocular hyperaemia
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
3.2%
2/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.7%
3/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
12.9%
8/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.7%
3/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
6.5%
4/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Gastrointestinal disorders
Constipation
|
21.4%
6/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
3.2%
2/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.4%
6/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
29.0%
18/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Gastrointestinal disorders
Dry mouth
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
6.5%
4/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.7%
3/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
19.4%
12/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Gastrointestinal disorders
Vomiting
|
17.9%
5/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
14.5%
9/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
General disorders
Asthenia
|
10.7%
3/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
14.5%
9/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
General disorders
Fatigue
|
17.9%
5/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
11.3%
7/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
General disorders
Oedema peripheral
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
12.9%
8/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
General disorders
Pyrexia
|
25.0%
7/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
11.3%
7/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Hepatobiliary disorders
Cholelithiasis
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Bronchitis
|
10.7%
3/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
6.5%
4/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Cellulitis
|
10.7%
3/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Chronic sinusitis
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Ear infection
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Eye infection
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Herpes zoster
|
14.3%
4/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
4.8%
3/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Influenza
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
3.2%
2/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Laryngitis
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Lower respiratory tract infection
|
17.9%
5/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
9.7%
6/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Lung infection
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Nasopharyngitis
|
32.1%
9/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
17.7%
11/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Oral herpes
|
10.7%
3/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Pharyngitis
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Rhinitis
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
12.9%
8/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Sinobronchitis
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
8.1%
5/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Infections and infestations
Urinary tract infection
|
10.7%
3/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
4.8%
3/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
10.7%
3/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Injury, poisoning and procedural complications
Contusion
|
35.7%
10/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
12.9%
8/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Injury, poisoning and procedural complications
Fall
|
28.6%
8/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
8.1%
5/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Injury, poisoning and procedural complications
Laceration
|
14.3%
4/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
10.7%
3/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Investigations
Blood bilirubin increased
|
3.6%
1/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
6.5%
4/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
9.7%
6/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
14.3%
4/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
3.2%
2/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
6.5%
4/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
28.6%
8/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
8.1%
5/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
3.2%
2/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
14.3%
4/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
9.7%
6/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
6.5%
4/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
8.1%
5/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.7%
3/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
3.2%
2/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
10.7%
3/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
21.4%
6/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Nervous system disorders
Dizziness
|
14.3%
4/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Nervous system disorders
Dysaesthesia
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Nervous system disorders
Headache
|
14.3%
4/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
8.1%
5/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Nervous system disorders
Paraesthesia
|
14.3%
4/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Psychiatric disorders
Anxiety
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
0.00%
0/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
8/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
14.5%
9/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
9.7%
6/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
6.5%
4/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
21.4%
6/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
6.5%
4/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
8.1%
5/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
6.5%
4/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Skin and subcutaneous tissue disorders
Acne
|
10.7%
3/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
10.7%
3/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
21.4%
6/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
4.8%
3/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
3.2%
2/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
17.9%
5/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
3.2%
2/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Skin and subcutaneous tissue disorders
Macule
|
21.4%
6/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
21.4%
6/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
14.5%
9/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
4/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
8.1%
5/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
17.9%
5/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
9.7%
6/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
10.7%
3/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
4.8%
3/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
10.7%
3/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
3.2%
2/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
7.1%
2/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
1.6%
1/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Vascular disorders
Haematoma
|
25.0%
7/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
4.8%
3/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
|
Vascular disorders
Hypertension
|
0.00%
0/28 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
6.5%
4/62 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 36 months); All-Cause Mortality: First dose date up to 39 months
The Safety Analysis Set included all the participants who received at least 1 dose of study drug. Per planned analysis, data were summarized by overall groups for NHL and CLL pooling all participants regardless of dose level received.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER