Trial Outcomes & Findings for Efficacy and Safety of Tislelizumab (BGB-A317) as Neo-Adjuvant Treatment in Participants With Colorectal Cancer (NCT NCT05116085)
NCT ID: NCT05116085
Last Updated: 2026-02-13
Results Overview
MPR rate is defined as the percentage of participants whose resected primary tumor shows 10% or less remaining viable cancer cells after completing neoadjuvant therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
Approximately 10 weeks after first dose of study treatment
Results posted on
2026-02-13
Participant Flow
Participants were enrolled in multiple study centers in China.
This study consisted of a screening phase (and/or prescreening phase) and a treatment phase that included a neoadjuvant phase, surgery, and a disease follow-up phase.
Participant milestones
| Measure |
Tislelizumab
Participants received tislelizumab 200 milligrams (mg) through an intravenous (IV) infusion once every 3 weeks for 3 treatment cycles before surgery (neoadjuvant therapy). After completing these 3 cycles, participants had their tumor surgically removed within 10 weeks of the first dose.
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|---|---|
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Overall Study
STARTED
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33
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Overall Study
Received Surgery
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29
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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33
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Reasons for withdrawal
| Measure |
Tislelizumab
Participants received tislelizumab 200 milligrams (mg) through an intravenous (IV) infusion once every 3 weeks for 3 treatment cycles before surgery (neoadjuvant therapy). After completing these 3 cycles, participants had their tumor surgically removed within 10 weeks of the first dose.
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Overall Study
Study Completed by Sponsor
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30
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Overall Study
Withdrawal by Subject
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2
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Overall Study
Death
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1
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Baseline Characteristics
Efficacy and Safety of Tislelizumab (BGB-A317) as Neo-Adjuvant Treatment in Participants With Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Tislelizumab
n=33 Participants
Participants received tislelizumab 200 milligrams (mg) through an intravenous (IV) infusion once every 3 weeks for 3 treatment cycles before surgery (neoadjuvant therapy). After completing these 3 cycles, participants had their tumor surgically removed within 10 weeks of the first dose.
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|---|---|
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Age, Continuous
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51.9 years
STANDARD_DEVIATION 16.30 • n=41 Participants
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Sex: Female, Male
Female
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19 Participants
n=41 Participants
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Sex: Female, Male
Male
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14 Participants
n=41 Participants
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Race/Ethnicity, Customized
Chinese
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33 Participants
n=41 Participants
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Region of Enrollment
China
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33 participants
n=41 Participants
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The Eastern Cooperative Oncology Group (ECOG) Performance Status
0 (fully Active)
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27 Participants
n=41 Participants
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The Eastern Cooperative Oncology Group (ECOG) Performance Status
1(Restrictive but Ambulatory)
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6 Participants
n=41 Participants
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PRIMARY outcome
Timeframe: Approximately 10 weeks after first dose of study treatmentPopulation: The Efficacy Analysis Set included all enrolled participants who received neoadjuvant treatment followed by surgery.
MPR rate is defined as the percentage of participants whose resected primary tumor shows 10% or less remaining viable cancer cells after completing neoadjuvant therapy.
Outcome measures
| Measure |
Tislelizumab
n=29 Participants
Participants received tislelizumab 200 milligrams (mg) through an intravenous (IV) infusion once every 3 weeks for 3 treatment cycles before surgery (neoadjuvant therapy). After completing these 3 cycles, participants had their tumor surgically removed within 10 weeks of the first dose.
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Major Pathological Response (MPR) Rate
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89.7 Percentage of Participants
Interval 72.6 to 97.8
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SECONDARY outcome
Timeframe: Approximately 10 weeks after first dose of study treatmentPopulation: Efficacy Analysis Set
Defined as the percentage of participants with a complete absence of residual tumor (no remaining cancer cells) in the surgically resected primary tumor and in all resected lymph nodes after completing neoadjuvant therapy.
Outcome measures
| Measure |
Tislelizumab
n=29 Participants
Participants received tislelizumab 200 milligrams (mg) through an intravenous (IV) infusion once every 3 weeks for 3 treatment cycles before surgery (neoadjuvant therapy). After completing these 3 cycles, participants had their tumor surgically removed within 10 weeks of the first dose.
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Pathological Complete Response (pCR) Rate
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62.1 Percentage of Participants
Interval 42.3 to 79.3
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SECONDARY outcome
Timeframe: From first dose to final analysis data cutoff (03JAN2025), disease progression, initiation of a new anticancer therapy, or death; whichever came first. Median follow-up was 21.7 months.Population: Safety Analysis Set
Defined as the time from the first dose of study treatment until the first occurrence of any of the following events: * Disease progression that prevents complete surgical remover of the tumor * Local or distant recurrence after surgery * Death from any cause The median and other quartiles of EFS were estimated using the Kaplan-Meier Method.
Outcome measures
| Measure |
Tislelizumab
n=33 Participants
Participants received tislelizumab 200 milligrams (mg) through an intravenous (IV) infusion once every 3 weeks for 3 treatment cycles before surgery (neoadjuvant therapy). After completing these 3 cycles, participants had their tumor surgically removed within 10 weeks of the first dose.
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Event Free Survival (EFS)
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NA Months
Medan and confidence interval could not be estimated due to an insufficient number of events
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SECONDARY outcome
Timeframe: 24 months and 36 months after first dosePopulation: Safety Analysis Set. No participants were evaluated for follow-up at 36 Months (3-Year).
The 2-year and 3-year EFS rates are defined as the percentage of participants without any EFS events at 24 months and 36 months after the first dose. EFS rates were estimated by the Kaplan-Meier method with 95% CI estimated using Greenwood's formula.
Outcome measures
| Measure |
Tislelizumab
n=33 Participants
Participants received tislelizumab 200 milligrams (mg) through an intravenous (IV) infusion once every 3 weeks for 3 treatment cycles before surgery (neoadjuvant therapy). After completing these 3 cycles, participants had their tumor surgically removed within 10 weeks of the first dose.
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2-Year and 3-Year Event Free Survival (EFS)
24 Months (2-Year)
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93.9 Percentage of Participants
Interval 77.9 to 98.4
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SECONDARY outcome
Timeframe: From the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first (up to 03JAN2025). Maximum treatment duration was 2.3 months.Population: Safety Analysis Set
The incidence of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and immune-mediated adverse events (imAEs), was assessed for all participants who received at least one dose of study treatment. SAEs were defined as events that resulted in death, were life-threatening, required or prolonged hospitalization, caused significant disability, or were considered important medical events. imAEs were defined as adverse events consistent with immune-related mechanisms, such as autoimmune-like toxicities requiring clinical evaluation or immunosuppressive management.
Outcome measures
| Measure |
Tislelizumab
n=33 Participants
Participants received tislelizumab 200 milligrams (mg) through an intravenous (IV) infusion once every 3 weeks for 3 treatment cycles before surgery (neoadjuvant therapy). After completing these 3 cycles, participants had their tumor surgically removed within 10 weeks of the first dose.
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Number of Participants Experiencing Adverse Events
TEAEs
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33 Participants
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Number of Participants Experiencing Adverse Events
Serious AEs
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4 Participants
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Number of Participants Experiencing Adverse Events
imAEs
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10 Participants
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Adverse Events
Tislelizumab
Serious events: 4 serious events
Other events: 31 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Tislelizumab
n=33 participants at risk
Participants received tislelizumab 200 milligrams (mg) through an intravenous (IV) infusion once every 3 weeks for 3 treatment cycles (ie, 9 weeks) before surgery (neoadjuvant therapy). After completing these 3 cycles, participants had their tumor surgically removed within 10 weeks of the first dose.
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Cardiac disorders
Cardiac arrest
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3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Cardiac disorders
Myocarditis
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3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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General disorders
Inflammation
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3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Infections and infestations
Skin infection
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3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Other adverse events
| Measure |
Tislelizumab
n=33 participants at risk
Participants received tislelizumab 200 milligrams (mg) through an intravenous (IV) infusion once every 3 weeks for 3 treatment cycles (ie, 9 weeks) before surgery (neoadjuvant therapy). After completing these 3 cycles, participants had their tumor surgically removed within 10 weeks of the first dose.
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Blood and lymphatic system disorders
Anaemia
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54.5%
18/33 • Number of events 27 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Blood and lymphatic system disorders
Lymphadenopathy
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3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Cardiac disorders
Mitral valve incompetence
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3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Cardiac disorders
Sinus arrhythmia
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3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Cardiac disorders
Sinus bradycardia
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12.1%
4/33 • Number of events 4 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Cardiac disorders
Supraventricular extrasystoles
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3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Endocrine disorders
Hyperthyroidism
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12.1%
4/33 • Number of events 4 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Endocrine disorders
Hypothyroidism
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9.1%
3/33 • Number of events 3 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Endocrine disorders
Thyroiditis
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3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Gastrointestinal disorders
Abdominal distension
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6.1%
2/33 • Number of events 2 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Gastrointestinal disorders
Abdominal pain
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12.1%
4/33 • Number of events 5 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Gastrointestinal disorders
Abdominal pain upper
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3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Gastrointestinal disorders
Anal incontinence
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3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Gastrointestinal disorders
Constipation
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3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Gastrointestinal disorders
Diarrhoea
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6.1%
2/33 • Number of events 2 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Gastrointestinal disorders
Gastrointestinal pain
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3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Gastrointestinal disorders
Haematochezia
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Gastrointestinal disorders
Intestinal obstruction
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3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Gastrointestinal disorders
Nausea
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15.2%
5/33 • Number of events 9 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Gastrointestinal disorders
Vomiting
|
12.1%
4/33 • Number of events 4 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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General disorders
Fatigue
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15.2%
5/33 • Number of events 5 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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General disorders
Malaise
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3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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|
General disorders
Pyrexia
|
12.1%
4/33 • Number of events 4 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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Hepatobiliary disorders
Cholecystitis
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
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Infections and infestations
Abdominal infection
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Influenza
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Periodontitis
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Pneumonia
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.0%
1/33 • Number of events 6 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Urinary tract infection
|
6.1%
2/33 • Number of events 2 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
12.1%
4/33 • Number of events 4 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
9.1%
3/33 • Number of events 3 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Wound complication
|
27.3%
9/33 • Number of events 9 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
6.1%
2/33 • Number of events 3 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Alpha hydroxybutyrate dehydrogenase increased
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Apolipoprotein A-I increased
|
12.1%
4/33 • Number of events 5 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Apolipoprotein B increased
|
6.1%
2/33 • Number of events 2 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
3/33 • Number of events 3 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Bile acids increased
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.1%
2/33 • Number of events 3 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood bilirubin increased
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood cholesterol increased
|
12.1%
4/33 • Number of events 9 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
9.1%
3/33 • Number of events 3 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.1%
2/33 • Number of events 2 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood urea increased
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
C-reactive protein increased
|
15.2%
5/33 • Number of events 7 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Cystatin C increased
|
3.0%
1/33 • Number of events 3 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Electrocardiogram T wave amplitude decreased
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Fibrin D dimer increased
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Fibrinogen degradation products increased
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Low density lipoprotein increased
|
12.1%
4/33 • Number of events 6 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Lymphocyte count decreased
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Neutrophil count decreased
|
12.1%
4/33 • Number of events 5 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Neutrophil count increased
|
9.1%
3/33 • Number of events 4 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Protein total decreased
|
9.1%
3/33 • Number of events 3 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Serum amyloid A protein increased
|
6.1%
2/33 • Number of events 3 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Troponin T increased
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Urine ketone body present
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Weight decreased
|
18.2%
6/33 • Number of events 6 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
White blood cell count decreased
|
6.1%
2/33 • Number of events 4 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
White blood cell count increased
|
9.1%
3/33 • Number of events 4 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
White blood cells urine positive
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
6.1%
2/33 • Number of events 3 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
15.2%
5/33 • Number of events 6 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
12.1%
4/33 • Number of events 5 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.1%
2/33 • Number of events 5 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
11/33 • Number of events 14 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.1%
2/33 • Number of events 2 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.1%
2/33 • Number of events 3 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.1%
3/33 • Number of events 3 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
3.0%
1/33 • Number of events 2 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Dizziness
|
6.1%
2/33 • Number of events 2 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
3/33 • Number of events 3 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.1%
3/33 • Number of events 3 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
6.1%
2/33 • Number of events 2 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.1%
2/33 • Number of events 2 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
3/33 • Number of events 4 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Vascular disorders
Hypotension
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment through to the end of the study, maximum duration was 35 months. Adverse events are reported from the first dose until 30 days (or 90 days for imAEs) after the last dose of tislelizumab, death, or start of new anticancer therapy, whichever occurred first; Maximum treatment duration was 2.3 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
|
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