Trial Outcomes & Findings for SHR-1210 in Recurrent/Metastatic Nasopharyngeal Carcinoma Who Have Received Previous At Least Two Lines of Chemotherapy. (NCT NCT03558191)

NCT ID: NCT03558191

Last Updated: 2024-03-15

Results Overview

Percentage of participants achieved partial response (PR) or complete response (CR) based on IRC assessment according to the RECIST (version 1.1) is presented for this endpoint. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks (28 days) after the criteria for response are first met. Only tumor assessments performed on or before the start date of any further anti-cancer therapies are considered in the assessment of best overall response .

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 156 participants
• Primary outcome timeframe: Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death ，whichever was earlier, approximately 3 years.
• Results posted on: 2024-03-15

Participant Flow

Participant milestones

Measure	SHR-1210 Injection SHR-1210 injection, 200 mg/dose, intravenous infusion over 30 minutes, once every 2 weeks . SHR-1210: A humanized monoclonal immunoglobulin PD-1 antibody
Overall Study STARTED	156
Overall Study Treated	156
Overall Study COMPLETED	131
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SHR-1210 in Recurrent/Metastatic Nasopharyngeal Carcinoma Who Have Received Previous At Least Two Lines of Chemotherapy.

Baseline characteristics by cohort

Measure	SHR-1210 Injection n=156 Participants SHR-1210 injection, 200 mg/dose, intravenous infusion over 30 minutes, once every 2 weeks . SHR-1210: A humanized monoclonal immunoglobulin PD-1 antibody
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	149 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	124 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	156 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment China	156 participants n=5 Participants

PRIMARY outcome

Timeframe: Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death ，whichever was earlier, approximately 3 years.

Population: The primary efficacy endpoint was analyzed in FAS.

Percentage of participants achieved partial response (PR) or complete response (CR) based on IRC assessment according to the RECIST (version 1.1) is presented for this endpoint.

Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks (28 days) after the criteria for response are first met. Only tumor assessments performed on or before the start date of any further anti-cancer therapies are considered in the assessment of best overall response .

Outcome measures

Measure	SHR-1210 Injection n=152 Participants SHR-1210 injection, 200 mg/dose, intravenous infusion over 30 minutes, once every 2 weeks . SHR-1210: A humanized monoclonal immunoglobulin PD-1 antibody
Objective Response Rate (ORR) Assess by Independent Review Committee (IRC)	28.3 percentage of participants Interval 21.3 to 36.2

SECONDARY outcome

Timeframe: Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.

Population: The secondary efficacy endpoint was analyzed in FAS.

Percentage of participants achieved partial response (PR) or complete response (CR) based on investigator assessment according to the RECIST (version 1.1) is presented for this endpoint.

Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks (28 days) after the criteria for response are first met. Only tumor assessments performed on or before the start date of any further anti-cancer therapies are considered in the assessment of best overall response.

Outcome measures

Measure	SHR-1210 Injection n=152 Participants SHR-1210 injection, 200 mg/dose, intravenous infusion over 30 minutes, once every 2 weeks . SHR-1210: A humanized monoclonal immunoglobulin PD-1 antibody
ORR Assess by Investigators	24.3 percentage of participants Interval 17.8 to 32.0

SECONDARY outcome

Timeframe: Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.

Population: The secondary efficacy endpoint was analyzed in FAS.

DoR is defined, for participants with a CR or PR per RECIST version 1.1, as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or death, whichever occurs first.

Outcome measures

Measure	SHR-1210 Injection n=152 Participants SHR-1210 injection, 200 mg/dose, intravenous infusion over 30 minutes, once every 2 weeks . SHR-1210: A humanized monoclonal immunoglobulin PD-1 antibody
Duration of Response (DoR)	20.3 month Interval 13.0 to 30.5

SECONDARY outcome

Timeframe: Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.

Population: The secondary efficacy endpoint was analyzed in FAS.

Percentage of participants achieving PR, CR or SD (SD ≥ 8 weeks) based on IRC assessment according to the RECIST version 1.1 is presented in this endpoint. DCR is a best overall response from the time of first dose to the documented objective progression or the subsequent anti-tumor therapy (whichever occurs first).

Outcome measures

Measure	SHR-1210 Injection n=152 Participants SHR-1210 injection, 200 mg/dose, intravenous infusion over 30 minutes, once every 2 weeks . SHR-1210: A humanized monoclonal immunoglobulin PD-1 antibody
Disease Control Rate (DCR)	54.6 percentage of participants Interval 46.3 to 62.7

SECONDARY outcome

Timeframe: Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.

Population: The secondary efficacy endpoint was analyzed in FAS.

PFS is defined as the time from the first dose to the date of the first documentation of PD or death, whichever occurs first. PFS was based on investigator assessment according to the RECIST version 1.1. PFS time was summarized using the Kaplan-Meier method.

Outcome measures

Measure	SHR-1210 Injection n=152 Participants SHR-1210 injection, 200 mg/dose, intravenous infusion over 30 minutes, once every 2 weeks . SHR-1210: A humanized monoclonal immunoglobulin PD-1 antibody
Progression-Free Survival (PFS)	3.7 month Interval 2.0 to 5.4

SECONDARY outcome

Timeframe: Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.

Population: The secondary efficacy endpoint was analyzed in FAS.

Overall Survival is defined as the time from the first dose to death due to any cause. OS time was measured using the Kaplan-Meier method.

Outcome measures

Measure	SHR-1210 Injection n=152 Participants SHR-1210 injection, 200 mg/dose, intravenous infusion over 30 minutes, once every 2 weeks . SHR-1210: A humanized monoclonal immunoglobulin PD-1 antibody
Overall Survival (OS)	18.7 month Interval 15.2 to 20.1

Adverse Events

SHR-1210 Injection

Serious events: 37 serious events

Other events: 154 other events

Deaths: 11 deaths

Serious adverse events

Measure	SHR-1210 Injection n=156 participants at risk SHR-1210 injection, 200 mg/dose, intravenous infusion over 30 minutes, once every 2 weeks . SHR-1210: A humanized monoclonal immunoglobulin PD-1 antibody
Respiratory, thoracic and mediastinal disorders epistaxis	2.6% 4/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders pulmonary inflammation	1.3% 2/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders respiratory failure	1.3% 2/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders progressive disease	4.5% 7/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders fever	1.9% 3/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations infectious pneumonia	1.3% 2/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Alanine aminotransferase increased	1.3% 2/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Aspartate aminotransferase increased	1.3% 2/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders upper gastrointestinal hemorrhage	1.3% 2/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Blood and lymphatic system disorders anemia	1.3% 2/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Immune system disorders Reactive capillary hyperplasia	2.6% 4/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Pharyngeal ulcer	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Bronchial hemorrhage	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Death	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Chest Discomfort	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Sinusitis	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Bacterial pneumonia	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Bronchitis	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations elevated GGT	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations elevated blood bilirubin	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Increased creatine phosphokinase	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations elevated blood alkaline phosphatase	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations decreased platelet count	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Brain radiation Injury	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Radiation osteonecrosis	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Infusion-related reactions	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Dysphagia	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hypoalbuminemia	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hyponatremia	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Headache	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of tongue	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Rash	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Cardiac disorders Sinus bradycardia	0.64% 1/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.

Other adverse events

Measure	SHR-1210 Injection n=156 participants at risk SHR-1210 injection, 200 mg/dose, intravenous infusion over 30 minutes, once every 2 weeks . SHR-1210: A humanized monoclonal immunoglobulin PD-1 antibody
Blood and lymphatic system disorders Anaemia	52.6% 82/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Endocrine disorders Hypothyroidism	26.9% 42/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Constipation	17.9% 28/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Vomiting	7.7% 12/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Diarrhoea	7.1% 11/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Abdominal pain	6.4% 10/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Dry mouth	6.4% 10/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Nausea	6.4% 10/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Pyrexia	25.0% 39/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Asthenia	22.4% 35/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Chest discomfort	9.0% 14/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Chest pain	9.0% 14/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Immune system disorders Reactive capillary endothelial proliferation	89.7% 140/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Upper respiratory tract infection	8.3% 13/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Nasopharyngitis	5.8% 9/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Aspartate aminotransferase increased	30.1% 47/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations White blood cell count decreased	23.7% 37/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Alanine aminotransferase increased	19.2% 30/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Occult blood positive	16.0% 25/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood thyroid stimulating hormone increased	14.1% 22/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Gamma-glutamyltransferase increased	10.3% 16/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Neutrophil count decreased	9.6% 15/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood creatinine increased	9.0% 14/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Urinary occult blood positive	9.0% 14/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Thyroxine free decreased	8.3% 13/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Weight decreased	7.7% 12/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood alkaline phosphatase increased	7.1% 11/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Platelet count decreased	7.1% 11/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood lactate dehydrogenase increased	6.4% 10/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Bilirubin conjugated increased	5.8% 9/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Lymphocyte count decreased	5.1% 8/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hypoalbuminaemia	19.9% 31/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Decreased appetite	16.0% 25/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hyponatraemia	13.5% 21/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hypokalaemia	9.6% 15/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hyperuricaemia	7.1% 11/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Hypocalcaemia	5.1% 8/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Back pain	14.1% 22/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Arthralgia	7.1% 11/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Pain in extremity	5.1% 8/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Headache	10.9% 17/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Hypoaesthesia	9.0% 14/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Dizziness	8.3% 13/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Renal and urinary disorders Proteinuria	14.7% 23/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Cough	32.7% 51/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Productive cough	16.0% 25/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Epistaxis	11.5% 18/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Haemoptysis	8.3% 13/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	6.4% 10/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.1% 8/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Tachypnoea	5.1% 8/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Pruritus	16.7% 26/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Rash	8.3% 13/156 • AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years). Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.

Additional Information

Project manager

Jiangsu HengRui Pharmaceuticals Co., Ltd.

Phone: 0518-82342973

Email: linan.wang@hengrui.com

Results disclosure agreements

• Principal investigator is a sponsor employee All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor.
• Publication restrictions are in place

Restriction type: OTHER