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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20180519 | Other Identifier | www.chinadrugtrials.org.cn |
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This is a multicenter, single-arm, phase II study to evaluate the efficacy and safety of CS1001 monotherapy for Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma (ENKTL)
Eligible subjects with rr-NKTL after prior asparaginase-based chemotherapy or chemo radiotherapy are planned to receive CS1001 1200 mg intravenous infusion every three weeks until progression of disease, intolerable toxicity, consent withdrawn, death. The primary endpoint of this trial is objective response rate (ORR), as assessed by independent radiological review committee (IRRC) based on Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CS1001 | Experimental | Participants will receive CS1001 1200 mg by intravenous infusion every 3 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS1001 | Biological | monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Assessed by IRRC | ORR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | From enrollment to end of follow-up, a median of 29 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Assessed by Investigators | ORR assessed by investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | From enrollment to end of follow-up, a median of 29 months |
| Complete Response Rate (CRR) by Investigators |
| Measure | Description | Time Frame |
|---|---|---|
| 6-months Progression-free Survival (PFS) Rate Assessed by Investigators | 6-months PFS rate assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | 6 months |
| 6-months PFS Rate Assessed by IRRC |
Inclusion Criteria:
Exclusion Criteria:
For more information regarding trial participation, please contact at cstonera@cstonepharma.com
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | China | ||||
| Hunan Cancer Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36996373 | Derived | Huang H, Tao R, Hao S, Yang Y, Cen H, Zhou H, Guo Y, Zou L, Cao J, Huang Y, Jin J, Zhang L, Yang H, Xing X, Zhang H, Liu Y, Ding K, Qi Q, Zhu X, Zhu D, Wang S, Fang T, Dai H, Shi Q, Yang J. Sugemalimab Monotherapy for Patients With Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma (GEMSTONE-201): Results From a Single-Arm, Multicenter, Phase II Study. J Clin Oncol. 2023 Jun 1;41(16):3032-3041. doi: 10.1200/JCO.22.02367. Epub 2023 Mar 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | R/R ENKTL | Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 25, 2021 | Mar 14, 2024 |
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CRR assessed by investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification |
| From enrollment to end of follow-up, a median of 29 months |
| Complete Response Rate (CRR) Assessed by IRRC | CRR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | From enrollment to end of follow-up, a median of 29 months |
| Partial Response Rate (PRR) Assessed by Investigators | PRR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | From enrollment to end of follow-up, a median of 29 months |
| Partial Response Rate (PRR) Assessed by IRRC | PRR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | From enrollment to end of follow-up, a median of 29 months |
| Duration of Response (DoR) Assessed by Investigators | DoR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | From enrollment to end of follow-up, a median of 29 months |
| Duration of Response (DoR) Assessed by IRRC | DoR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | From enrollment to end of follow-up, a median of 29 months |
| Time to Response (TTR) Assessed by Investigators | TTR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | From enrollment to end of follow-up, a median of 29 months |
| Time to Response (TTR) Assessed by IRRC | TTR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | From enrollment to end of follow-up, a median of 29 months |
| Number of Participants With Adverse Events | From enrollment to end of follow-up, a median of 29 months |
6-months PFS rate assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
| 6 months |
| 6-month Overall Survival (OS) Rate | 6 months |
| Changsha |
| China |
| West China Hospital of Sichuan University | Chengdu | China |
| Fujian Cancer Hospital | Fuzhou | China |
| Sun Yat-sen University Cancer Prevention Center | Guangzhou | China |
| Guizhou Cancer Hospital | Guiyang | China |
| The First Affiliated Hospital of Zhejiang University | Hangzhou | China |
| Zhejiang Cancer Hospital | Hangzhou | China |
| Anhui Cancer Hospital | Hefei | China |
| Cancer Hospital Affiliated to Guangxi Medical University | Nanning | China |
| Fudan University Shanghai Cancer Hospital | Shanghai | China |
| Shanghai East Hospital | Shanghai | China |
| Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | China |
| Liaoning Cancer Hospital | Shenyang | China |
| Tianjin Cancer Hospital | Tianjin | China |
| Cancer Center of Union Hospital, Huazhong University of Science and Technology | Wuhan | China |
| Henan Cancer Hospital | Zhengzhou | China |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | R/R ENKTL | Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| |||||||||||||||||||||||
| Eastern Cooperative Oncology Group Performance Status | 0-Fully active, able to carry on all pre-disease performance without restriction. 1-Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2-Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours. 3-Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. 4-Completely disabled; cannot carry on any selfcare; totally confined to bed or chair. 5-Dead | Count of Participants | Participants |
| ||||||||||||||||||||||
| Stage of Extranodal Natural Killer/ T-cell Lymphoma at screening | Based on Ann Arbor classification: Stage I - Involvement: 1 node or a group of adjacent nodes. Extranodal Status: Single extranodal lesion without nodal involvement. Stage II - Involvement: 2 or more nodal groups on the same side of the diaphragm. Extranodal Status: Stage I/II by nodal extent with limited contiguous extranodal involvement. Stage III - Involvement: Nodes on both sides of the diaphragm; nodes above the diaphragm with spleen involvement. Extranodal Status: N/A. Stage IV - Involvement: Additional noncontiguous extralymphatic involvement. Extranodal Status: N/A. | Count of Participants | Participants |
| ||||||||||||||||||||||
| Epstein-Barr Virus (EBV) DNA at Screening | Count of Participants | Participants |
| |||||||||||||||||||||||
| Baseline Bone Marrow Assessment Result | Assessments were performed at baseline to determine whether a patient had bone marrow involvement by the disease. "Positive" indicates the presence of involvement; "negative" indicates absence of involvement; "missing" indicates results not applicable. | Count of Participants | Participants |
| ||||||||||||||||||||||
| Central Pathology Confirmed ENKTL | Count of Participants | Participants |
| |||||||||||||||||||||||
| Patient Status | Participants in this study must have relapsed or refractory ENKTL failing asparaginase-based chemotherapy or chemoradiotherapy. "Relapse" indicates disease progression after response to the last treatment; "refractory" indicates no response to the last treatment. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) Assessed by IRRC | ORR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | Two patients were excluded from analysis: one patient was not confirmed as ENKTL by central pathology, and the other patient was identified as having no measurable or evaluable disease at baseline by IRRC. | Posted | Number | 95% Confidence Interval | percentage of Participants | From enrollment to end of follow-up, a median of 29 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) Assessed by Investigators | ORR assessed by investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | One patient was excluded from the efficacy analysis set because the patient was not confirmed as ENKTL by central pathology. | Posted | Number | 95% Confidence Interval | Percentage of participants | From enrollment to end of follow-up, a median of 29 months |
|
| ||||||||||||||||||||||||||
| Secondary | Complete Response Rate (CRR) by Investigators | CRR assessed by investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | One patient was excluded from the efficacy analysis set because the patient was not confirmed as ENKTL by central pathology. | Posted | Number | 95% Confidence Interval | Percentage of participants | From enrollment to end of follow-up, a median of 29 months |
|
| ||||||||||||||||||||||||||
| Secondary | Complete Response Rate (CRR) Assessed by IRRC | CRR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | Two patients were excluded from analysis: one patient was not confirmed as ENKTL by central pathology, and the other patient was identified as having no measurable or evaluable disease at baseline by IRRC. | Posted | Number | 95% Confidence Interval | Percentage of participants | From enrollment to end of follow-up, a median of 29 months |
|
| ||||||||||||||||||||||||||
| Secondary | Partial Response Rate (PRR) Assessed by Investigators | PRR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | One patient was excluded from the efficacy analysis set because the patient was not confirmed as ENKTL by central pathology. | Posted | Number | 95% Confidence Interval | Percentage of participants | From enrollment to end of follow-up, a median of 29 months |
|
| ||||||||||||||||||||||||||
| Secondary | Partial Response Rate (PRR) Assessed by IRRC | PRR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | Two patients were excluded from analysis: one patient was not confirmed as ENKTL by central pathology, and the other patient was identified as having no measurable or evaluable disease at baseline by IRRC. | Posted | Number | 95% Confidence Interval | Percentage of participants | From enrollment to end of follow-up, a median of 29 months |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) Assessed by Investigators | DoR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | One patient was excluded from the efficacy analysis set because the patient was not confirmed as ENKTL by central pathology. | Posted | Median | 95% Confidence Interval | months | From enrollment to end of follow-up, a median of 29 months |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) Assessed by IRRC | DoR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | Two patients were excluded from analysis: one patient was not confirmed as ENKTL by central pathology, and the other patient was identified as having no measurable or evaluable disease at baseline by IRRC. | Posted | Median | 95% Confidence Interval | months | From enrollment to end of follow-up, a median of 29 months |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) Assessed by Investigators | TTR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | One patient was excluded from the efficacy analysis set because the patient was not confirmed as ENKTL by central pathology. | Posted | Median | Full Range | months | From enrollment to end of follow-up, a median of 29 months |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) Assessed by IRRC | TTR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | Two patients were excluded from analysis: one patient was not confirmed as ENKTL by central pathology, and the other patient was identified as having no measurable or evaluable disease at baseline by IRRC. | Posted | Median | Full Range | months | From enrollment to end of follow-up, a median of 29 months |
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| Secondary | Number of Participants With Adverse Events | Posted | Count of Participants | Participants | From enrollment to end of follow-up, a median of 29 months |
|
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| ||||||||||||||||||||||||||||
| Other Pre-specified | 6-months Progression-free Survival (PFS) Rate Assessed by Investigators | 6-months PFS rate assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | one patient was excluded from the efficacy analysis set because the patient was not confirmed as ENKTL by central pathology. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | 6-months PFS Rate Assessed by IRRC | 6-months PFS rate assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification | Two patients were excluded from analysis: one patient was not confirmed as ENKTL by central pathology, and the other patient was identified as having no measurable or evaluable disease at baseline by IRRC. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | 6-month Overall Survival (OS) Rate | One patient was excluded from the efficacy analysis set because the patient was not confirmed as ENKTL by central pathology. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months |
|
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From enrollment to end of follow-up, a median of 29 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | R/R ENKTL | Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W) | 37 | 80 | 22 | 80 | 76 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Sinus node dysfunction | Cardiac disorders | Systematic Assessment |
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| Deafness bilateral | Ear and labyrinth disorders | Systematic Assessment |
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| Duodenal perforation | Gastrointestinal disorders | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Death | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | Systematic Assessment |
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| Haemophagocytic lymphohistiocytosis | Immune system disorders | Systematic Assessment |
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| Fungaemia | Infections and infestations | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Septic shock | Infections and infestations | Systematic Assessment |
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| Soft tissue infection | Infections and infestations | Systematic Assessment |
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| Ear injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Electrolyte imbalance | Metabolism and nutrition disorders | Systematic Assessment |
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| Myositis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Confusional state | Psychiatric disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| COVID-19 | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
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| Blood bilirubin increased | Investigations | Systematic Assessment |
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| Blood creatinine increased | Investigations | Systematic Assessment |
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| Blood thyroid stimulating hormone decreased | Investigations | Systematic Assessment |
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| Blood thyroid stimulating hormone increased | Investigations | Systematic Assessment |
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| Haemoglobin decreased | Investigations | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | Systematic Assessment |
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| Neutrophil count decreased | Investigations | Systematic Assessment |
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| Platelet count decreased | Investigations | Systematic Assessment |
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| Protein urine present | Investigations | Systematic Assessment |
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| Thyroxine free decreased | Investigations | Systematic Assessment |
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| Urinary occult blood positive | Investigations | Systematic Assessment |
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| Urobilinogen urine increased | Investigations | Systematic Assessment |
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| Weight decreased | Investigations | Systematic Assessment |
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| White blood cell count decreased | Investigations | Systematic Assessment |
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| White blood cells urine positive | Investigations | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypochloraemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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If the sponsor has not published trial results within 18 months since trial completion, the PI is allowed to publish data collected at the corresponding site. The PI should provide draft publication to the sponsor to review prior to distribution to any external parties; the sponsor should provide review comments to the PI within 60 calendar days since receipt of draft publication; the sponsor also has rights to postpone publication for up to 6 months based on reasonable grounds.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zhang Wenyun | CStone Pharmaceuticals | +86 021-60333416 | CstoneRA@cstonepharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 4, 2021 | Mar 14, 2024 | SAP_001.pdf |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
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| Title | Measurements |
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| Stage IV |
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| Missing |
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| Treatment-Related Adverse Event (TRAE) |
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| Serious Adverse Event (SAE) |
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| Related SAE |
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| ≥G3 TEAE |
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| ≥G3 TRAE |
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| Infusion-related Reaction |
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| TEAE of special interest |
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| TEAE of special interest grade 3-5 |
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| TEAE Leading to Death |
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| TEAE Leading to Drug Permanently Discontinued |
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| TEAE Leading to Infusion Interruption |
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| TEAE Leading to Treatment Cycle Delay |
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