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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20221154 | Other Identifier | ChinaDrugTrials |
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This was an open-label, multi-center, single-arm, Phase 1 study. The purpose of this study was for evaluating the safety and pharmacokinetics of dinutuximab beta as maintenance therapy in Chinese participants with high-risk neuroblastoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dinutuximab Beta + 13-cis-Retinoic Acid | Experimental | The study recruited participants who were hospitalized (with full resuscitation equipment) on Day 1 of each cycle and received continuous infusion of dinutuximab beta for 10 consecutive days in 35-day cycles. Participants could be discharged from the hospital at the investigator's discretion. Participants continued to receive 13-cis-retinoic acid orally for 14 days after completion of dinutuximab beta infusion (day 12-25 in each cycle). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dinutuximab Beta | Drug | Dinutuximab beta was administered intravenously at a dosage of 10 milligrams/ meters squared (mg/m2) per day for 10 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Number of participants with treatment-emergent adverse events (TEAEs) and serious treatment-emergent adverse event, characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 [NCI-CTCAE v 5.0]), timing, seriousness, relationship to study treatment, and other safety assessments. | From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month |
| Area Under the Serum Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of Dinutuximab Beta | From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days) | |
| Area Under the Serum Concentration-time Curve From Zero to Infinity (AUC0-∞) of Dinutuximab Beta | From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days) | |
| Maximum Observed Serum Concentration (Cmax) of Dinutuximab Beta | From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days) | |
| Time to Maximum Serum Concentration (Tmax) of Dinutuximab Beta | From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days) | |
| Half-Life (t1/2) of Dinutuximab Beta | From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days) | |
| Clearance (CL) of Dinutuximab Beta | From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days) | |
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Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine | Shanghai | Shanghai Municipality | China | |||
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Participants were enrolled in three study centers across China. The study was conducted from June 7th, 2022, and completed on June 29, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dinutuximab Beta + 13-cis-Retinoic Acid | The study recruited participants who were hospitalized (with full resuscitation equipment) on Day 1 of each cycle and received continuous infusion of dinutuximab beta for 10 consecutive days in 35-day cycles. Participants could be discharged from the hospital at the investigator's discretion. Participants continued to receive 13-cis-retinoic acid orally for 14 days after completion of dinutuximab beta infusion (day 12-25 in each cycle). Dinutuximab Beta: Dinutuximab beta was administered intravenously at a dosage of 10 milligrams/ meters squared (mg/m2/day) for 10 consecutive days. 13-cis-Retinoic Acid: 13-cis-Retinoic Acid was administered orally at a daily total dose of 160 mg/m2, divided into approximately two equal doses given twice daily for 14 days following the conclusion of dinutuximab beta infusion. |
| 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 | Jun 9, 2023 | Jun 20, 2024 |
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| 13-cis-Retinoic Acid | Drug | 13-cis-Retinoic Acid was administered orally at a daily total dose of 160 mg/m2, divided into approximately two equal doses given twice daily for 14 days following the conclusion of dinutuximab beta infusion. |
|
| Volume of Distribution During Terminal Phase (Vz) of Dinutuximab Beta |
| From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days) |
| Volume of Distribution at Steady State (Vss) of Dinutuximab Beta | From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days) |
| Tianjin Medical University Cancer Institute & Hospital |
| Tianjin |
| Tianjin Municipality |
| China |
| The Children's Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dinutuximab Beta + 13-cis-Retinoic Acid | The study recruited participants who were hospitalized (with full resuscitation equipment) on Day 1 of each cycle and received continuous infusion of dinutuximab beta for 10 consecutive days in 35-day cycles. Participants could be discharged from the hospital at the investigator's discretion. Participants continued to receive 13-cis-retinoic acid orally for 14 days after completion of dinutuximab beta infusion (day 12-25 in each cycle). Dinutuximab Beta: Dinutuximab beta was administered intravenously at a dosage of 10 milligrams/ meters squared (mg/m2/day) for 10 consecutive days 13-cis-Retinoic Acid: 13-cis-Retinoic Acid was administered orally at a daily total dose of 160 mg/m2, divided into approximately two equal doses given twice daily for 14 days following the conclusion of dinutuximab beta infusion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| 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 | Number of Participants With Adverse Events (AEs) | Number of participants with treatment-emergent adverse events (TEAEs) and serious treatment-emergent adverse event, characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 [NCI-CTCAE v 5.0]), timing, seriousness, relationship to study treatment, and other safety assessments. | The Safety Analysis Set included all participants who received at least one dose of dinutuximab beta. | Posted | Count of Participants | Participants | From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month |
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| |||||||||||||||||||||||||||||||||
| Primary | Area Under the Serum Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of Dinutuximab Beta | Pharmacokinetic (PK) Analysis Set was defined as participants who had at least 1 available postbaseline PK data in the Safety Analysis Set. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*micrograms/milliliter (h*ug/mL) | From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days) |
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| ||||||||||||||||||||||||||||||||||
| Primary | Area Under the Serum Concentration-time Curve From Zero to Infinity (AUC0-∞) of Dinutuximab Beta | Pharmacokinetic (PK) Analysis Set was defined as participants who had at least 1 available postbaseline PK data in the Safety Analysis Set. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days) |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Maximum Observed Serum Concentration (Cmax) of Dinutuximab Beta | Pharmacokinetic (PK) Analysis Set was defined as participants who had at least 1 available postbaseline PK data in the Safety Analysis Set. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days) |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Time to Maximum Serum Concentration (Tmax) of Dinutuximab Beta | Pharmacokinetic (PK) Analysis Set was defined as participants who had at least 1 available postbaseline PK data in the Safety Analysis Set. | Posted | Median | Full Range | hours | From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days) |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Half-Life (t1/2) of Dinutuximab Beta | Pharmacokinetic (PK) Analysis Set was defined as participants who had at least 1 available postbaseline PK data in the Safety Analysis Set. | Posted | Geometric Mean | Full Range | hours | From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days) |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Clearance (CL) of Dinutuximab Beta | Pharmacokinetic (PK) Analysis Set was defined as participants who had at least 1 available postbaseline PK data in the Safety Analysis Set. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/h | From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days) |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Volume of Distribution During Terminal Phase (Vz) of Dinutuximab Beta | Pharmacokinetic (PK) Analysis Set was defined as participants who had at least 1 available postbaseline PK data in the Safety Analysis Set. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL | From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days) |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Volume of Distribution at Steady State (Vss) of Dinutuximab Beta | Pharmacokinetic (PK) Analysis Set was defined as participants who had at least 1 available postbaseline PK data in the Safety Analysis Set. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL | From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days) |
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All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
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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 | Dinutuximab Beta + 13-cis-Retinoic Acid | The study recruited participants who were hospitalized (with full resuscitation equipment) on Day 1 of each cycle and received continuous infusion of dinutuximab beta for 10 consecutive days in 35-day cycles. Participants could be discharged from the hospital at the investigator's discretion. Participants continued to receive 13-cis-retinoic acid orally for 14 days after completion of dinutuximab beta infusion (day 12-25 in each cycle). Dinutuximab beta was administered intravenously at a dosage of 10 mg/m2/day for 10 days 13-cis-Retinoic Acid was administered orally at a daily total dose of 160 mg/m², divided into approximately two equal doses given twice daily for 14 days following the conclusion of dinutuximab beta infusion. | 0 | 8 | 1 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | meddra 25.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | meddra 25.0 | Systematic Assessment |
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| Eosinophilia | Blood and lymphatic system disorders | meddra 25.0 | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | meddra 25.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | meddra 25.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | meddra 25.0 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | meddra 25.0 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | meddra 25.0 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | meddra 25.0 | Systematic Assessment |
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| Conjunctivitis allergic | Eye disorders | meddra 25.0 | Systematic Assessment |
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| Dry eye | Eye disorders | meddra 25.0 | Systematic Assessment |
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| Photophobia | Eye disorders | meddra 25.0 | Systematic Assessment |
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| Swelling of eyelid | Eye disorders | meddra 25.0 | Systematic Assessment |
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| Vision blurred | Eye disorders | meddra 25.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
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| Anal pruritus | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
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| Angular cheilitis | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
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| Cheilitis | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
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| Chills | General disorders | meddra 25.0 | Systematic Assessment |
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| Face oedema | General disorders | meddra 25.0 | Systematic Assessment |
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| Gait disturbance | General disorders | meddra 25.0 | Systematic Assessment |
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| Malaise | General disorders | meddra 25.0 | Systematic Assessment |
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| Pyrexia | General disorders | meddra 25.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | meddra 25.0 | Systematic Assessment |
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| Catheter site infection | Infections and infestations | meddra 25.0 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | meddra 25.0 | Systematic Assessment |
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| Gastrointestinal infection | Infections and infestations | meddra 25.0 | Systematic Assessment |
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| Myringitis | Infections and infestations | meddra 25.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | meddra 25.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | meddra 25.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | meddra 25.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | meddra 25.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | meddra 25.0 | Systematic Assessment |
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| Alpha tumour necrosis factor increased | Investigations | meddra 25.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | meddra 25.0 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | meddra 25.0 | Systematic Assessment |
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| Blood cholesterol increased | Investigations | meddra 25.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | meddra 25.0 | Systematic Assessment |
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| Blood fibrinogen decreased | Investigations | meddra 25.0 | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | meddra 25.0 | Systematic Assessment |
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| Brain natriuretic peptide increased | Investigations | meddra 25.0 | Systematic Assessment |
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| C-reactive protein increased | Investigations | meddra 25.0 | Systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | meddra 25.0 | Systematic Assessment |
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| Fibrin D dimer increased | Investigations | meddra 25.0 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | meddra 25.0 | Systematic Assessment |
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| Heart rate increased | Investigations | meddra 25.0 | Systematic Assessment |
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| Interleukin level increased | Investigations | meddra 25.0 | Systematic Assessment |
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| Interleukin-2 receptor increased | Investigations | meddra 25.0 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | meddra 25.0 | Systematic Assessment |
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| N-terminal prohormone brain natriuretic peptide increased | Investigations | meddra 25.0 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | meddra 25.0 | Systematic Assessment |
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| Neutrophil percentage increased | Investigations | meddra 25.0 | Systematic Assessment |
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| Oxygen saturation decreased | Investigations | meddra 25.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | meddra 25.0 | Systematic Assessment |
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| Procalcitonin increased | Investigations | meddra 25.0 | Systematic Assessment |
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| SARS-CoV-2 test positive | Investigations | meddra 25.0 | Systematic Assessment |
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| Weight increased | Investigations | meddra 25.0 | Systematic Assessment |
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| White blood cell count decreased | Investigations | meddra 25.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
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| Hypophagia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
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| Vitamin D deficiency | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
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| Myositis | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | meddra 25.0 | Systematic Assessment |
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| Occipital neuralgia | Nervous system disorders | meddra 25.0 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | meddra 25.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | meddra 25.0 | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | meddra 25.0 | Systematic Assessment |
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| Pruritus genital | Reproductive system and breast disorders | meddra 25.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
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| Macule | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
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| Papule | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
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| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
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| Capillary leak syndrome | Vascular disorders | meddra 25.0 | Systematic Assessment |
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| Haemorrhage | Vascular disorders | meddra 25.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | meddra 25.0 | Systematic Assessment |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BeiGene | +1-877-828-5568 | clinicaltrials@beigene.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 6, 2023 | Jun 20, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| C112746 | dinutuximab |
| D015474 | Isotretinoin |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
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