Trial Outcomes & Findings for Study of BTK Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macroglobulinemia (WM) (NCT NCT03332173)
NCT ID: NCT03332173
Last Updated: 2024-10-26
Results Overview
MRR is defined as the percentage of participants who achieved complete response (CR) + very good partial response (VGPR) + partial response (PR), as assessed by an independent review committee according to modified Owen's criteria
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Up to approximately 1 year and 9 months
Results posted on
2024-10-26
Participant Flow
This study enrolled participants at 10 study centers in China. The first participant was dosed on 31 August 2017, and the last participant enrolled and received their first dose of zanubrutinib on 08 May 2018. A total of 44 participants were enrolled and all received at least 1 dose of the study drug.
The protocol-defined efficacy analyses were performed 12 months after the last patient received the first dose of study drug, with a data cutoff date of 08 May 2019.
Participant milestones
| Measure |
Zanubrutinib
Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
44
|
Reasons for withdrawal
| Measure |
Zanubrutinib
Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
|
|---|---|
|
Overall Study
Death
|
7
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Transferred to long-term extension study
|
29
|
Baseline Characteristics
Study of BTK Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macroglobulinemia (WM)
Baseline characteristics by cohort
| Measure |
Zanubrutinib
n=44 Participants
Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
|
|---|---|
|
Age, Continuous
|
64.7 Years
STANDARD_DEVIATION 8.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 1 year and 9 monthsPopulation: Efficacy Analysis Set includes participants with confirmed Waldenström's macroglobulinemia based on central pathologic review among those who received at least one dose of study drug and with a baseline IgM (or M-protein) ≥ 5 g/L
MRR is defined as the percentage of participants who achieved complete response (CR) + very good partial response (VGPR) + partial response (PR), as assessed by an independent review committee according to modified Owen's criteria
Outcome measures
| Measure |
Zanubrutinib
n=43 Participants
Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
|
|---|---|
|
Major Response Rate (MRR) as Assessed by the Independent Review Committee
|
69.8 Percentage of participants
Interval 53.87 to 82.82
|
SECONDARY outcome
Timeframe: Up to approximately 1 year and 9 monthsPopulation: Efficacy Analysis Set includes participants with confirmed Waldenström's macroglobulinemia based on central pathologic review among those who received at least one dose of study drug and with a baseline IgM (or M-protein) ≥ 5 g/L
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by an independent review committee using modified Owen's criteria
Outcome measures
| Measure |
Zanubrutinib
n=43 Participants
Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
|
|---|---|
|
Progression Free Survival (PFS)
|
NA Months
Interval 16.53 to
NA = not estimable; could not be calculated due insufficient number participants with events
|
SECONDARY outcome
Timeframe: Up to approximately 1 year and 9 monthsPopulation: Efficacy Analysis Set includes participants with confirmed Waldenström's macroglobulinemia based on central pathologic review among those who received at least one dose of study drug and with a baseline IgM (or M-protein) ≥ 5 g/L
Progression/death event-free rates were estimated by Kaplan-Meier method with 95% confidence intervals (CIs) estimated using Greenwood's formula
Outcome measures
| Measure |
Zanubrutinib
n=43 Participants
Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
|
|---|---|
|
PFS: Event-free Rate
6 months
|
89.8 Percentage of participants
Interval 75.1 to 96.1
|
|
PFS: Event-free Rate
9 months
|
87.0 Percentage of participants
Interval 71.5 to 94.4
|
|
PFS: Event-free Rate
12 months
|
77.8 Percentage of participants
Interval 60.2 to 88.3
|
SECONDARY outcome
Timeframe: Up to approximately 1 year and 9 monthsPopulation: Efficacy Analysis Set includes participants with confirmed Waldenström's macroglobulinemia based on central pathologic review among those who received at least one dose of study drug and with a baseline IgM (or M-protein) ≥ 5 g/L
ORR is defined as the percentage of participants with a minor, partial, very good partial, and complete response, as assessed by an independent review committee using modified Owen's criteria
Outcome measures
| Measure |
Zanubrutinib
n=43 Participants
Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
|
|---|---|
|
Overall Response Rate (ORR)
|
79.1 Percentage of participants
Interval 63.96 to 89.96
|
SECONDARY outcome
Timeframe: Up to approximately 1 year and 9 monthsPopulation: Efficacy Analysis Set includes participants with confirmed Waldenström's macroglobulinemia based on central pathologic review among those who received at least one dose of study drug and with a baseline IgM (or M-protein) ≥ 5 g/L
DOMR is defined as the time from the date that the major response criteria are first met to the date that progressive disease (PD) is objectively documented or death, whichever comes first, as assessed by an independent review committee using modified Owen's criteria
Outcome measures
| Measure |
Zanubrutinib
n=43 Participants
Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
|
|---|---|
|
Duration of Major Response (DOMR)
|
NA Months
Interval 13.77 to
NA = not estimable, could not be calculated due insufficient number participants with events
|
SECONDARY outcome
Timeframe: Up to approximately 1 year and 9 monthsPopulation: Efficacy Analysis Set includes participants with confirmed Waldenström's macroglobulinemia based on central pathologic review among those who received at least one dose of study drug and with a baseline IgM (or M-protein) ≥ 5 g/L
DOMR event-free rates were estimated by Kaplan-Meier method with 95% CIs estimated using Greenwood's formula
Outcome measures
| Measure |
Zanubrutinib
n=43 Participants
Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
|
|---|---|
|
DOMR: Event-free Rate
6 months
|
96.2 Percentage of participants
Interval 75.7 to 99.4
|
|
DOMR: Event-free Rate
9 months
|
87.0 Percentage of participants
Interval 64.7 to 95.6
|
|
DOMR: Event-free Rate
12 months
|
87.0 Percentage of participants
Interval 64.7 to 95.6
|
SECONDARY outcome
Timeframe: Up to approximately 1 year and 9 monthsPopulation: Efficacy Analysis Set includes participants with confirmed Waldenström's macroglobulinemia based on central pathologic review among those who received at least one dose of study drug and with a baseline IgM (or M-protein) ≥ 5 g/L
Number of participants with resolution of treatment-precipitating symptoms, defined as any resolution (from "Yes" at baseline to "No" at any postbaseline point onwards during study) of the indications for initiation of therapy in WM signs and symptoms evaluation.
Outcome measures
| Measure |
Zanubrutinib
n=43 Participants
Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
|
|---|---|
|
Number of Participants With Resolution of Treatment-precipitating Symptoms
|
35 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 1 year and 9 monthsPopulation: Efficacy Analysis Set includes participants with confirmed Waldenström's macroglobulinemia based on central pathologic review among those who received at least one dose of study drug and with a baseline IgM (or M-protein) ≥ 5 g/L
Number of participants with an anti-lymphoma effect, defined as any reduction during the course of study in bone marrow involvement by lymphoplasmacytoid lymphocytes and/or size of lymphadenopathy and/or splenomegaly by computed tomography scan as assessed by an independent review committee; lymphadenopathy is defined as any node with longest diameter (LDi) \> 1.5 cm and splenomegaly is defined as vertical spleen length \> 13 cm
Outcome measures
| Measure |
Zanubrutinib
n=43 Participants
Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
|
|---|---|
|
Number of Participants With an Anti-lymphoma Effect
|
34 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 3 years and 5 monthsPopulation: The Safety Analysis Set included all participants who received ≥ 1 dose of study drug
Number of participants with treatment-emergent adverse events (TEAEs), grade 3 or higher TEAEs, serious adverse events (SAEs), treatment-related adverse events (AEs), adverse events of special interest, and TEAEs leading to study drug discontinuation, dose reduction and treatment interruption
Outcome measures
| Measure |
Zanubrutinib
n=44 Participants
Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
|
|---|---|
|
Number of Participants With Adverse Events
At least one TEAE
|
44 Participants
|
|
Number of Participants With Adverse Events
Grade 3 or higher TEAEs
|
34 Participants
|
|
Number of Participants With Adverse Events
Serious TEAEs
|
25 Participants
|
|
Number of Participants With Adverse Events
Treatment-related TEAEs
|
41 Participants
|
|
Number of Participants With Adverse Events
TEAEs of special interest
|
43 Participants
|
|
Number of Participants With Adverse Events
TEAEs leading to study drug discontinuation
|
5 Participants
|
|
Number of Participants With Adverse Events
TEAEs leading to treatment interruption
|
17 Participants
|
|
Number of Participants With Adverse Events
TEAEs leading to dose reduction
|
1 Participants
|
Adverse Events
Zanubrutinib
Serious events: 25 serious events
Other events: 44 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Zanubrutinib
n=44 participants at risk
Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Cardiac disorders
Coronary artery disease
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Eye disorders
Cataract
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Eye disorders
Macular degeneration
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Gastrointestinal disorders
Dysbiosis
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
General disorders
Death
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
General disorders
Multiple organ dysfunction syndrome
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Infections and infestations
Abscess limb
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Infections and infestations
Acute hepatitis B
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Infections and infestations
Epididymitis
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Infections and infestations
Pneumonia
|
22.7%
10/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Infections and infestations
Pulmonary mycosis
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Infections and infestations
Skin infection
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Infections and infestations
Upper respiratory tract infection
|
6.8%
3/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Injury, poisoning and procedural complications
Fracture
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Investigations
Platelet count decreased
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Waldenstrom's macroglobulinaemia
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Nervous system disorders
Intracranial mass
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Nervous system disorders
Post herpetic neuralgia
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Nervous system disorders
Syncope
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Vascular disorders
Hypertension
|
2.3%
1/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
Other adverse events
| Measure |
Zanubrutinib
n=44 participants at risk
Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
18.2%
8/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.8%
3/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Cardiac disorders
Angina pectoris
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Eye disorders
Cataract
|
6.8%
3/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Eye disorders
Conjunctival haemorrhage
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Eye disorders
Ocular discomfort
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Eye disorders
Retinal haemorrhage
|
6.8%
3/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.8%
3/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Gastrointestinal disorders
Constipation
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
11/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Gastrointestinal disorders
Flatulence
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Gastrointestinal disorders
Gastritis
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Gastrointestinal disorders
Gingival bleeding
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Gastrointestinal disorders
Gingival pain
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Gastrointestinal disorders
Toothache
|
6.8%
3/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
3/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
General disorders
Chest discomfort
|
11.4%
5/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
General disorders
Chest pain
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
General disorders
Fatigue
|
6.8%
3/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
General disorders
Oedema peripheral
|
9.1%
4/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
General disorders
Pyrexia
|
13.6%
6/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Infections and infestations
Bronchitis
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Infections and infestations
Conjunctivitis
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Infections and infestations
Herpes zoster
|
6.8%
3/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Infections and infestations
Nasopharyngitis
|
13.6%
6/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Infections and infestations
Periodontitis
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Infections and infestations
Pharyngitis
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Infections and infestations
Pneumonia
|
20.5%
9/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Infections and infestations
Sinusitis
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Infections and infestations
Tonsillitis
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Infections and infestations
Upper respiratory tract infection
|
27.3%
12/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Infections and infestations
Urinary tract infection
|
18.2%
8/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Injury, poisoning and procedural complications
Fracture
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Injury, poisoning and procedural complications
Limb injury
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Investigations
Alanine aminotransferase increased
|
11.4%
5/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Investigations
Aspartate aminotransferase increased
|
11.4%
5/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Investigations
Bilirubin conjugated increased
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Investigations
Blood alkaline phosphatase increased
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Investigations
Blood bilirubin increased
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Investigations
Blood creatinine increased
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Investigations
Blood immunoglobulin M increased
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Investigations
Carbon dioxide increased
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Investigations
Electrocardiogram QT prolonged
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.8%
3/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Investigations
Lymphocyte count decreased
|
9.1%
4/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Investigations
Neutrophil count decreased
|
59.1%
26/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Investigations
Platelet count decreased
|
29.5%
13/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Investigations
Weight decreased
|
6.8%
3/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Investigations
Weight increased
|
22.7%
10/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Investigations
White blood cell count decreased
|
31.8%
14/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Investigations
White blood cells urine positive
|
6.8%
3/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.9%
7/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.4%
5/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
9.1%
4/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
13.6%
6/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.6%
6/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.5%
9/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
4/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Nervous system disorders
Dizziness
|
9.1%
4/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Nervous system disorders
Headache
|
6.8%
3/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Psychiatric disorders
Insomnia
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Renal and urinary disorders
Haematuria
|
6.8%
3/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.6%
6/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
4/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.1%
4/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.8%
3/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
9.1%
4/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Skin and subcutaneous tissue disorders
Purpura
|
18.2%
8/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.2%
8/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
4.5%
2/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
|
Vascular disorders
Hypertension
|
18.2%
8/44 • Up to approximately 3 years and 5 months
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
- Publication restrictions are in place
Restriction type: OTHER