Trial Outcomes & Findings for Study of Tislelizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (NCT NCT04004221)
NCT ID: NCT04004221
Last Updated: 2024-10-26
Results Overview
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by Independent Review Committee (IRC) using RECIST version 1.1
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
113 participants
Primary outcome timeframe
From the date of first dose up to approximately 2 years and 2 months
Results posted on
2024-10-26
Participant Flow
113 participants were enrolled in 27 centers in China and 3 centers in South Korea. All efficacy evaluations were done until 16 September 2019, the primary data cut-off date. Safety evaluations were done until 11 March 2021, the study completion date.
Participant milestones
| Measure |
Tislelizumab
Participants received 200mg tislelizumab intravenously (IV) every 3 weeks (Q3W) until disease progression or death
|
|---|---|
|
Overall Study
STARTED
|
113
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
113
|
Reasons for withdrawal
| Measure |
Tislelizumab
Participants received 200mg tislelizumab intravenously (IV) every 3 weeks (Q3W) until disease progression or death
|
|---|---|
|
Overall Study
Death
|
89
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Participants transferred to Long-Term Extension (LTE) study
|
9
|
|
Overall Study
Sponsor Decision
|
9
|
|
Overall Study
Participant refused to enter LTE
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tislelizumab
n=113 Participants
Participants received 200mg tislelizumab intravenously (IV) every 3 weeks (Q3W) until disease progression or death
|
|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 7.85 • n=113 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=113 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=113 Participants
|
|
Region of Enrollment
South Korea
|
5 participants
n=113 Participants
|
|
Region of Enrollment
China
|
108 participants
n=113 Participants
|
PRIMARY outcome
Timeframe: From the date of first dose up to approximately 2 years and 2 monthsPopulation: The Efficacy Evaluable Analysis Set includes all participants who received any dose of tislelizumab and had measurable disease per IRC according to RECIST version 1.1 at baseline
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by Independent Review Committee (IRC) using RECIST version 1.1
Outcome measures
| Measure |
Tislelizumab
n=104 Participants
Participants received 200mg tislelizumab IV Q3W until disease progression or death
|
|---|---|
|
Objective Response Rate (ORR) as Assessed by Independent Review Committee (IRC)
|
24.0 Percentage of participants
Interval 16.2 to 33.41
|
SECONDARY outcome
Timeframe: From the date of first dose up to approximately 2 years and 2 monthsPopulation: Efficacy Evaluable Analysis Set
DOR - defined as the time from the first determination of a confirmed objective response by IRC according to RECIST version 1.1 until the first documentation of progression or death, whichever comes first
Outcome measures
| Measure |
Tislelizumab
n=104 Participants
Participants received 200mg tislelizumab IV Q3W until disease progression or death
|
|---|---|
|
Duration of Response (DOR) as Assessed by IRC
|
NA Months
Interval 8.41 to
NA = Not Estimable due to insufficient number of events
|
SECONDARY outcome
Timeframe: From the date of first dose up to approximately 2 years and 2 monthsPopulation: Efficacy Evaluable Set
PFS is defined as the time from the date of first dose of study drug to the date of first documentation of disease progression assessed by IRC using RECIST version 1.1 or death, whichever occurs first
Outcome measures
| Measure |
Tislelizumab
n=104 Participants
Participants received 200mg tislelizumab IV Q3W until disease progression or death
|
|---|---|
|
Progression-Free Survival (PFS) as Assessed by IRC
|
2.1 Months
Interval 2.04 to 3.15
|
SECONDARY outcome
Timeframe: From the date of first dose up to approximately 2 years and 2 monthsPopulation: Efficacy Evaluable Set
DCR is defined as the percentage of participants who achieve CR, PR and stable disease (SD) assessed by IRC using RECIST version 1.1
Outcome measures
| Measure |
Tislelizumab
n=104 Participants
Participants received 200mg tislelizumab IV Q3W until disease progression or death
|
|---|---|
|
Disease Control Rate (DCR) as Assessed by IRC
|
38.5 Percentage of participants
Interval 29.09 to 48.51
|
SECONDARY outcome
Timeframe: From the date of first dose up to approximately 2 years and 2 monthsPopulation: Safety Analysis Set
OS - defined as the time from the date of first dose of study drug until the date of death from any cause
Outcome measures
| Measure |
Tislelizumab
n=113 Participants
Participants received 200mg tislelizumab IV Q3W until disease progression or death
|
|---|---|
|
Overall Survival (OS)
|
9.8 Months
Interval 7.46 to 12.48
|
SECONDARY outcome
Timeframe: From the date of first dose up to approximately 2 years and 2 monthsPopulation: Efficacy Evaluable Analysis Set
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the investigators per RECIST version 1.1 and immune related RECIST (irRECIST)
Outcome measures
| Measure |
Tislelizumab
n=104 Participants
Participants received 200mg tislelizumab IV Q3W until disease progression or death
|
|---|---|
|
ORR as Assessed by the Investigators
RECIST
|
24.0 Percentage of participants
Interval 16.2 to 33.41
|
|
ORR as Assessed by the Investigators
irRECIST
|
24.0 Percentage of participants
Interval 16.2 to 33.41
|
SECONDARY outcome
Timeframe: From the date of first dose up to approximately 2 years and 2 monthsPopulation: Efficacy Evaluable Analysis Set
DOR is defined as the time from the first determination of a confirmed objective response by the investigator according to RECIST version 1.1 and irRECIST until the first documentation of progression or death, whichever comes first
Outcome measures
| Measure |
Tislelizumab
n=104 Participants
Participants received 200mg tislelizumab IV Q3W until disease progression or death
|
|---|---|
|
DOR as Assessed by Investigators Per RECIST Version 1.1 and irRECIST
RECIST
|
NA Months
Interval 8.31 to
NA = Not Estimable due to insufficient number of events
|
|
DOR as Assessed by Investigators Per RECIST Version 1.1 and irRECIST
irRECIST
|
NA Months
Interval 8.31 to
NA = Not Estimable due to insufficient number of events
|
SECONDARY outcome
Timeframe: From the date of first dose up to approximately 2 years and 2 monthsPopulation: Efficacy Evaluable Analysis Set
PFS is defined as the time from the date of first dose of study drug to the date of first documentation of disease progression assessed by the investigator according to RECIST version 1.1 and irRECIST until the first documentation of progression or death, whichever comes first
Outcome measures
| Measure |
Tislelizumab
n=104 Participants
Participants received 200mg tislelizumab IV Q3W until disease progression or death
|
|---|---|
|
PFS as Assessed by Investigators Per RECIST Version 1.1 and irRECIST
RECIST
|
2.1 Months
Interval 2.07 to 3.58
|
|
PFS as Assessed by Investigators Per RECIST Version 1.1 and irRECIST
irRECIST
|
2.6 Months
Interval 2.07 to 4.07
|
SECONDARY outcome
Timeframe: From the date of first dose up to approximately 2 years and 2 monthsPopulation: Efficacy Evaluable Analysis Set
DCR is defined as the percentage of participants who achieve CR, PR and stable disease (SD) assessed by investigators per RECIST version 1.1 and irRECIST
Outcome measures
| Measure |
Tislelizumab
n=104 Participants
Participants received 200mg tislelizumab IV Q3W until disease progression or death
|
|---|---|
|
DCR as Assessed by Investigators Per RECIST Version 1.1 and irRECIST
RECIST
|
41.3 Percentage of participants
Interval 31.77 to 51.42
|
|
DCR as Assessed by Investigators Per RECIST Version 1.1 and irRECIST
irRECIST
|
46.2 Percentage of participants
Interval 36.33 to 56.2
|
SECONDARY outcome
Timeframe: From the date of first dose until End of Study (approximately 3 years and 9 months)Population: Safety Analysis Set
TEAE is defined as an adverse event (AE) that had an onset date or a worsening in severity from baseline pre-treatment) on or after the first dose of study drug up to 30 days following study drug .discontinuation. An SAE is any untoward medical occurrence that, at any dose that results in death or is life-threatening.
Outcome measures
| Measure |
Tislelizumab
n=113 Participants
Participants received 200mg tislelizumab IV Q3W until disease progression or death
|
|---|---|
|
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with At Least 1 TEAE
|
112 Number of participants
|
|
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Grade 3 or Higher
|
64 Number of participants
|
|
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Serious TEAEs
|
49 Number of participants
|
Adverse Events
Tislelizumab
Serious events: 49 serious events
Other events: 110 other events
Deaths: 89 deaths
Serious adverse events
| Measure |
Tislelizumab
n=113 participants at risk
Participants received 200mg tislelizumab intravenously Q3W until disease progression or death.
|
|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Cardiac disorders
Cardiac failure
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Cardiac disorders
Ventricular fibrillation
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Gastrointestinal disorders
Gastritis
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Gastrointestinal disorders
Ileus
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
General disorders
Death
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
General disorders
General physical health deterioration
|
2.7%
3/113 • Number of events 3 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
General disorders
Oedema peripheral
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
General disorders
Pyrexia
|
3.5%
4/113 • Number of events 4 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Hepatobiliary disorders
Hepatic failure
|
2.7%
3/113 • Number of events 3 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Hepatobiliary disorders
Liver injury
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Infections and infestations
Abdominal infection
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Infections and infestations
Febrile infection
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Infections and infestations
Kidney infection
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Infections and infestations
Pneumonia
|
3.5%
4/113 • Number of events 4 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Infections and infestations
Sepsis
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
3/113 • Number of events 3 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Infections and infestations
Urinary tract infection
|
2.7%
3/113 • Number of events 3 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Injury, poisoning and procedural complications
Optic nerve injury
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Investigations
Alanine aminotransferase increased
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Investigations
Platelet count decreased
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.8%
2/113 • Number of events 3 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.8%
2/113 • Number of events 2 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.8%
2/113 • Number of events 3 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Nervous system disorders
Brain oedema
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Nervous system disorders
Dizziness
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Nervous system disorders
Paraplegia
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Product Issues
Device occlusion
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Renal and urinary disorders
Haematuria
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Renal and urinary disorders
Hydronephrosis
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Renal and urinary disorders
Renal failure
|
1.8%
2/113 • Number of events 2 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Renal and urinary disorders
Renal impairment
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Renal and urinary disorders
Renal injury
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated pneumonitis
|
0.88%
1/113 • Number of events 2 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
2.7%
3/113 • Number of events 3 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Vascular disorders
Deep vein thrombosis
|
1.8%
2/113 • Number of events 2 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Vascular disorders
Shock haemorrhagic
|
0.88%
1/113 • Number of events 1 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
Other adverse events
| Measure |
Tislelizumab
n=113 participants at risk
Participants received 200mg tislelizumab intravenously Q3W until disease progression or death.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
38.9%
44/113 • Number of events 58 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Endocrine disorders
Hyperthyroidism
|
5.3%
6/113 • Number of events 7 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Endocrine disorders
Hypothyroidism
|
9.7%
11/113 • Number of events 19 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Gastrointestinal disorders
Abdominal distension
|
10.6%
12/113 • Number of events 15 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
9/113 • Number of events 9 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Gastrointestinal disorders
Constipation
|
22.1%
25/113 • Number of events 28 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
8.8%
10/113 • Number of events 10 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Gastrointestinal disorders
Nausea
|
11.5%
13/113 • Number of events 16 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Gastrointestinal disorders
Vomiting
|
8.8%
10/113 • Number of events 11 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
General disorders
Asthenia
|
8.0%
9/113 • Number of events 12 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
General disorders
Fatigue
|
8.8%
10/113 • Number of events 10 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
General disorders
Oedema peripheral
|
7.1%
8/113 • Number of events 8 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
General disorders
Pyrexia
|
19.5%
22/113 • Number of events 27 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Infections and infestations
Nasopharyngitis
|
8.8%
10/113 • Number of events 14 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
9.7%
11/113 • Number of events 12 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Infections and infestations
Urinary tract infection
|
20.4%
23/113 • Number of events 33 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Investigations
Alanine aminotransferase increased
|
16.8%
19/113 • Number of events 25 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Investigations
Aspartate aminotransferase increased
|
19.5%
22/113 • Number of events 28 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Investigations
Blood alkaline phosphatase increased
|
13.3%
15/113 • Number of events 19 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Investigations
Blood bilirubin increased
|
7.1%
8/113 • Number of events 13 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Investigations
Blood creatine phosphokinase MB increased
|
6.2%
7/113 • Number of events 10 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Investigations
Blood creatinine increased
|
16.8%
19/113 • Number of events 21 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Investigations
Blood lactate dehydrogenase increased
|
8.8%
10/113 • Number of events 11 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Investigations
Blood urea increased
|
8.0%
9/113 • Number of events 12 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.1%
8/113 • Number of events 8 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Investigations
Neutrophil count decreased
|
5.3%
6/113 • Number of events 18 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Investigations
Platelet count decreased
|
5.3%
6/113 • Number of events 7 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Investigations
Weight decreased
|
6.2%
7/113 • Number of events 7 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Investigations
White blood cell count decreased
|
7.1%
8/113 • Number of events 15 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.4%
23/113 • Number of events 27 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
7/113 • Number of events 8 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.2%
7/113 • Number of events 9 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
5.3%
6/113 • Number of events 16 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.2%
7/113 • Number of events 12 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
17.7%
20/113 • Number of events 24 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.3%
6/113 • Number of events 6 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
18.6%
21/113 • Number of events 25 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.6%
12/113 • Number of events 16 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Nervous system disorders
Dizziness
|
5.3%
6/113 • Number of events 7 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Psychiatric disorders
Insomnia
|
5.3%
6/113 • Number of events 7 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Renal and urinary disorders
Haematuria
|
7.1%
8/113 • Number of events 9 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Renal and urinary disorders
Proteinuria
|
8.0%
9/113 • Number of events 11 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
9/113 • Number of events 9 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.4%
23/113 • Number of events 34 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.0%
17/113 • Number of events 27 • From the date of first dose until end of study (approximately 3 years and 9 months)
|
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