Trial Outcomes & Findings for Study of BTK Inhibitor Zanubrutinib in Participants With Relapsed/Refractory Non-GCB Type Diffuse Large B Cell Lymphoma (NCT NCT03145064)
NCT ID: NCT03145064
Last Updated: 2024-10-26
Results Overview
Overall response rate was defined as the percentage of participants achieving either a partial response (PR) or complete response (CR) as determined by investigator according to the 2014 modification of the International Working Group (IWG) in Non-Hodgkin's lymphoma (NHL) Criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Up to approximately 23 months
Results posted on
2024-10-26
Participant Flow
This study was conducted at 11 centers in China, all of which enrolled participants. The first participant was dosed on 30 June 2017. Since the primary and secondary objectives were met and the analysis was complete, the sponsor ended the study on 03 September 2020 (Last patient last visit). As of the final database lock (15 October 2020), 41 participants were enrolled and treated with zanubrutinib.
Participant milestones
| Measure |
Zanubrutinib
Participants received 160 milligrams (mg) of zanubrutinib twice daily (BID).
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
Received At Least 1 Dose of Study Drug
|
41
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
| Measure |
Zanubrutinib
Participants received 160 milligrams (mg) of zanubrutinib twice daily (BID).
|
|---|---|
|
Overall Study
Death
|
24
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Study ended by sponsor once primary/ secondary analysis was complete and participants discontinued
|
4
|
|
Overall Study
Other: Transferred to Long term Extension (LTE) study BGB-3111-LTE1 (NCT04170283)
|
4
|
Baseline Characteristics
Study of BTK Inhibitor Zanubrutinib in Participants With Relapsed/Refractory Non-GCB Type Diffuse Large B Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Zanubrutinib
n=41 Participants
Participants received 160 mg of zanubrutinib BID.
|
|---|---|
|
Age, Continuous
|
57.2 years
STANDARD_DEVIATION 12.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Grade 0
|
10 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Grade 1
|
27 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
Grade 2
|
4 Participants
n=5 Participants
|
|
Hepatitis B Core Antibody
Positive
|
13 Participants
n=5 Participants
|
|
Hepatitis B Core Antibody
Negative
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 23 monthsPopulation: The Safety Analysis Set, which included all participants who received any dose of study drug, was the analysis set used for the efficacy and safety analyses.
Overall response rate was defined as the percentage of participants achieving either a partial response (PR) or complete response (CR) as determined by investigator according to the 2014 modification of the International Working Group (IWG) in Non-Hodgkin's lymphoma (NHL) Criteria.
Outcome measures
| Measure |
Zanubrutinib
n=41 Participants
Participants received 160 mg of zanubrutinib BID.
|
|---|---|
|
Overall Response Rate
|
29.3 percentage of participants
Interval 16.13 to 45.54
|
SECONDARY outcome
Timeframe: Up to 3 years and 2 monthsPopulation: The Safety Analysis Set, which included all participants who received any dose of study drug, was the analysis set used for the efficacy and safety analyses
Progression-free survival was defined as the time from first dose of zanubrutinib until first documentation of progression (by IWG on NHL criteria) or death, whichever occurred first.
Outcome measures
| Measure |
Zanubrutinib
n=41 Participants
Participants received 160 mg of zanubrutinib BID.
|
|---|---|
|
Progression-free Survival
|
2.8 months
Interval 2.56 to 5.45
|
SECONDARY outcome
Timeframe: Up to 3 years and 2 monthsPopulation: The Safety Analysis Set, which included all participants who received any dose of study drug, was the analysis set used for the efficacy and safety analyses
Duration of response was defined as the time from the date that the response criteria were first met to the date that progressive disease was objectively documented or death, whichever occurred first. Duration of response was summarized for responders (with a best overall response of CR or PR) only.
Outcome measures
| Measure |
Zanubrutinib
n=12 Participants
Participants received 160 mg of zanubrutinib BID.
|
|---|---|
|
Duration Of Response
|
4.5 months
Interval 2.14 to
NA = Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to 3 years and 2 monthsPopulation: The Safety Analysis Set, which included all participants who received any dose of study drug, was the analysis set used for the efficacy and safety analyses.
Time to response was defined as the time from the first dose of zanubrutinib to the documentation of first response. Time to response was summarized for responders (with a best overall response of CR or PR) only.
Outcome measures
| Measure |
Zanubrutinib
n=12 Participants
Participants received 160 mg of zanubrutinib BID.
|
|---|---|
|
Time To Response
|
2.83 months
Interval 2.6 to 3.2
|
SECONDARY outcome
Timeframe: From the time of informed consent to 30 days after the last dose of study drug (approximately Up to 3 years and 2 months)Population: The Safety Analysis Set included all participants who received any dose of study drug.
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
Outcome measures
| Measure |
Zanubrutinib
n=41 Participants
Participants received 160 mg of zanubrutinib BID.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with at least1 TEAE
|
36 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Serious TEAE
|
12 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAE leading to treatment discontinuation
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 years and 2 monthsPopulation: The Safety Analysis Set, which included all participants who received any dose of study drug, was the analysis set used for the efficacy and safety analyses.
Overall survival was defined as the time from first dose of zanubrutinib until death due to any cause.
Outcome measures
| Measure |
Zanubrutinib
n=41 Participants
Participants received 160 mg of zanubrutinib BID.
|
|---|---|
|
Overall Survival
|
8.4 months
Interval 4.8 to
NA = Not estimable due to insufficient number of participants with events
|
Adverse Events
Zanubrutinib
Serious events: 12 serious events
Other events: 34 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Zanubrutinib
n=41 participants at risk
Participants received 160 mg of zanubrutinib BID.
|
|---|---|
|
Infections and infestations
Pneumonia
|
7.3%
3/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Abdominal infection
|
2.4%
1/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Herpes zoster
|
2.4%
1/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Otitis media chronic
|
2.4%
1/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Urinary tract infection
|
2.4%
1/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
General disorders
Death
|
4.9%
2/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
General disorders
Gait inability
|
2.4%
1/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.4%
1/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
2.4%
1/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Eye disorders
Cataract
|
2.4%
1/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Hepatobiliary disorders
Liver injury
|
2.4%
1/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
2.4%
1/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
1/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
Other adverse events
| Measure |
Zanubrutinib
n=41 participants at risk
Participants received 160 mg of zanubrutinib BID.
|
|---|---|
|
Investigations
Neutrophil count decreased
|
22.0%
9/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Investigations
Platelet count decreased
|
12.2%
5/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Investigations
Blood creatinine increased
|
9.8%
4/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Investigations
Lymphocyte count decreased
|
9.8%
4/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Investigations
White blood cell count decreased
|
9.8%
4/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Investigations
Alanine aminotransferase increased
|
7.3%
3/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Investigations
Aspartate aminotransferase increased
|
7.3%
3/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Investigations
Weight decreased
|
7.3%
3/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Investigations
Blood alkaline phosphatase increased
|
4.9%
2/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Investigations
Blood bilirubin increased
|
4.9%
2/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Constipation
|
9.8%
4/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.8%
4/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
17.1%
7/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.9%
2/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.9%
2/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
4.9%
2/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
4.9%
2/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.9%
2/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Urinary tract infection
|
9.8%
4/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Pneumonia
|
7.3%
3/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
3/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Nasopharyngitis
|
4.9%
2/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Skin infection
|
4.9%
2/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.8%
4/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.8%
4/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.9%
2/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.3%
3/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.3%
3/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
4.9%
2/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
General disorders
Influenza like illness
|
4.9%
2/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
General disorders
Malaise
|
4.9%
2/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
General disorders
Oedema peripheral
|
4.9%
2/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.3%
3/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.3%
3/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Vascular disorders
Hypertension
|
9.8%
4/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
|
Ear and labyrinth disorders
Tinnitus
|
4.9%
2/41 • From the time of informed consent to 30 days after the last dose of study drug (approximately up to 3 years and 2 months).
A treatment-emergent adverse event was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up Visit) or initiation of new anticancer therapy, whichever occurred first.
|
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