Not provided
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| Name | Class |
|---|---|
| Daiichi Sankyo | INDUSTRY |
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of T-DXd in participants with HER2 mutant metastatic non-squamous NSCLC.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T-DXd arm | Experimental | Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab deruxtecan | Drug | administered as an IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| ICR-assessed ORR (Objective Response Rate) | Confirmed ORR, defined as the percentage of participants with confirmed complete response or partial response, as assessed by independent central review(ICR) based on RECIST 1.1. | Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months. (from date of enrolment to final analysis data cut-off) |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-assessed ORR (Objective Response Rate) | Confirmed ORR is defined as the percentage of participants who have a confirmed CR or confirmed PR, as determined by the investigator at local site per RECIST 1.1 | Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months. (from date of enrolment to final analysis data cut-off) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Baoding | 071000 | China | |||
| Research Site |
Not provided
| Label | URL |
|---|---|
| Redacted CSP | View source |
| Redacted SAP | View source |
Not provided
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | T-DXd Arm | Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 24, 2022 | Sep 4, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ICR-assessed DoR (Duration of Response) | DoR is time from the initial confirmed response (CR or PR) until documented tumour progression or death from any cause. | Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months. |
| Investigator-assessed DoR (Duration of Response) | DoR is time from the initial confirmed response (CR or PR) until documented tumour progression or death from any cause. | Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months. |
| ICR-assessed and Investigator-assessed DCR (Disease Control Rate) | DCR is the percentage of participants who achieved confirmed CR, PR, or SD during study intervention. | Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months. |
| ICR-assessed and Investigator-assessed PFS (Progression-free Survival) | PFS is the time from date of enrolment until first objective radiographic tumour progression or death from any cause. | Tumour assessments every 6 weeks after enrolment for the first 48 weeks and then every 9 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Assessed up to 28 months. |
| OS (Overall Survival) | OS is the time from date of enrolment until death from any cause. | From date of enrolment until death due to any cause. Assessed up to 28 months. |
| ICR-assessed CNS-PFS (Central Nervous System Progression-free Survival) | CNS-PFS is the time from date of enrolment until CNS tumour progression per RECIST 1.1 as assessed by ICR or death due to any cause in the absence of CNS progression. | Tumour assessments every 6 weeks after enrolment for the first 48 weeks and then every 9 weeks thereafter until date of RECIST 1.1 defined CNS tumour progressive disease or death in the absence of CNS progression. Assessed up to 28 months. |
| Serum Concentrations of T-DXd | Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for T-DXd. | 24 weeks from day 1 of cycle 1 to cycle 8 |
| Serum Concentrations of Total Anti-HER2 Antibody | Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for total anti-HER2 antibody. | 24 weeks from day 1 of cycle 1 to cycle 8 |
| Serum Concentrations of DXd | Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for DXd. | 24 weeks from day 1 of cycle 1 to cycle 8 |
| Beijing |
| 100142 |
| China |
| Research Site | Beijing | 100191 | China |
| Research Site | Changchun | 130000 | China |
| Research Site | Changsha | 410008 | China |
| Research Site | Changsha | 410013 | China |
| Research Site | Chengdu | 610041 | China |
| Research Site | Chongqing | 400030 | China |
| Research Site | Guangzhou | 510080 | China |
| Research Site | Guangzhou | 510515 | China |
| Research Site | Hangzhou | 310020 | China |
| Research Site | Hangzhou | 310022 | China |
| Research Site | Harbin | 150081 | China |
| Research Site | Hefei | 133500 | China |
| Research Site | Hefei | 230601 | China |
| Research Site | Linyi | 276000 | China |
| Research Site | Nanjing | 210029 | China |
| Research Site | Shandong | China |
| Research Site | Shanghai | 200025 | China |
| Research Site | Shanghai | 200032 | China |
| Research Site | Shenyang | 110042 | China |
| Research Site | Shenzhen | 518020 | China |
| Research Site | Wuhan | 430022 | China |
| Research Site | Wuhan | 430060 | China |
| Research Site | Xi'an | 710061 | China |
| Research Site | Xiamen | 361003 | China |
| Research Site | Yangzhou | 225001 | China |
| Research Site | Zhengzhou | 450000 | China |
| Redacted CSR synopsis | View source |
| Redacted CSR synopsis version 2.0 | View source |
| COMPLETED | As of the DCO for this final analysis (04 November 2024), patients in the remaining studies were considered to have completed the study at DCO, with the exception of those who were withdrawn due to death, patient withdrawal, or lost to follow-up. |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | T-DXd Arm | Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | Years |
| |||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Investigator-assessed ORR (Objective Response Rate) | Confirmed ORR is defined as the percentage of participants who have a confirmed CR or confirmed PR, as determined by the investigator at local site per RECIST 1.1 | Full analysis set | Posted | Number | 95% Confidence Interval | Percentage of participants | Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months. (from date of enrolment to final analysis data cut-off) |
|
|
| |||||||||||||||||||||||||
| Secondary | ICR-assessed DoR (Duration of Response) | DoR is time from the initial confirmed response (CR or PR) until documented tumour progression or death from any cause. | Full analysis set (patients with confirmed objective response included in the analysis) | Posted | Median | 95% Confidence Interval | Months | Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months. |
|
| ||||||||||||||||||||||||||
| Secondary | Investigator-assessed DoR (Duration of Response) | DoR is time from the initial confirmed response (CR or PR) until documented tumour progression or death from any cause. | Full analysis set (patients with confirmed objective response included in the analysis) | Posted | Median | 95% Confidence Interval | Months | Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months. |
|
| ||||||||||||||||||||||||||
| Secondary | ICR-assessed and Investigator-assessed DCR (Disease Control Rate) | DCR is the percentage of participants who achieved confirmed CR, PR, or SD during study intervention. | Full analysis set | Posted | Number | 95% Confidence Interval | Percentage of participants | Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months. |
|
| ||||||||||||||||||||||||||
| Secondary | ICR-assessed and Investigator-assessed PFS (Progression-free Survival) | PFS is the time from date of enrolment until first objective radiographic tumour progression or death from any cause. | Full analysis set | Posted | Median | 95% Confidence Interval | Months | Tumour assessments every 6 weeks after enrolment for the first 48 weeks and then every 9 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Assessed up to 28 months. |
|
| ||||||||||||||||||||||||||
| Secondary | OS (Overall Survival) | OS is the time from date of enrolment until death from any cause. | Full analysis set | Posted | Median | 95% Confidence Interval | Months | From date of enrolment until death due to any cause. Assessed up to 28 months. |
|
| ||||||||||||||||||||||||||
| Secondary | ICR-assessed CNS-PFS (Central Nervous System Progression-free Survival) | CNS-PFS is the time from date of enrolment until CNS tumour progression per RECIST 1.1 as assessed by ICR or death due to any cause in the absence of CNS progression. | Full analysis set | Posted | Median | 95% Confidence Interval | Months | Tumour assessments every 6 weeks after enrolment for the first 48 weeks and then every 9 weeks thereafter until date of RECIST 1.1 defined CNS tumour progressive disease or death in the absence of CNS progression. Assessed up to 28 months. |
|
| ||||||||||||||||||||||||||
| Secondary | Serum Concentrations of T-DXd | Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for T-DXd. | PK analysis set | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | 24 weeks from day 1 of cycle 1 to cycle 8 |
|
| ||||||||||||||||||||||||||
| Secondary | Serum Concentrations of Total Anti-HER2 Antibody | Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for total anti-HER2 antibody. | PK analysis set | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | 24 weeks from day 1 of cycle 1 to cycle 8 |
|
| ||||||||||||||||||||||||||
| Secondary | Serum Concentrations of DXd | Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for DXd. | PK analysis set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 24 weeks from day 1 of cycle 1 to cycle 8 |
|
| ||||||||||||||||||||||||||
| Primary | ICR-assessed ORR (Objective Response Rate) | Confirmed ORR, defined as the percentage of participants with confirmed complete response or partial response, as assessed by independent central review(ICR) based on RECIST 1.1. | Full analysis set | Posted | Number | 95% Confidence Interval | Percentage of participants | Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months. (from date of enrolment to final analysis data cut-off) |
|
|
From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | T-DXd | Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle. | 41 | 72 | 41 | 72 | 72 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Covid-19 pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diaphragmatic hernia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Covid-19 pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Alpha hydroxybutyrate dehydrogenase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Bile acids increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood bilirubin unconjugated increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 22, 2023 | Sep 4, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000614160 | trastuzumab deruxtecan |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
| Title | Denominators | Categories |
|---|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Cycle 1 Pre-dose |
|
| ||||
| Cycle 1 End of infusion |
|
| ||||
| Cycle 1 5 hour post-dose |
|
| ||||
| Cycle 2 Pre-dose |
|
| ||||
| Cycle 2 End of infusion |
|
| ||||
| Cycle 3 Pre-dose |
|
| ||||
| Cycle 3 End of infusion |
|
| ||||
| Cycle 4 Pre-dose |
|
| ||||
| Cycle 4 End of infusion |
|
| ||||
| Cycle 6 Pre-dose |
|
| ||||
| Cycle 8 Pre-dose |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Cycle 1 Pre-dose |
|
| ||||
| Cycle 1 End of infusion |
|
| ||||
| Cycle 1 5 hour post-dose |
|
| ||||
| Cycle 2 Pre-dose |
|
| ||||
| Cycle 2 End of infusion |
|
| ||||
| Cycle 3 Pre-dose |
|
| ||||
| Cycle 3 End of infusion |
|
| ||||
| Cycle 4 Pre-dose |
|
| ||||
| Cycle 4 End of infusion |
|
| ||||
| Cycle 6 Pre-dose |
|
| ||||
| Cycle 8 Pre-dose |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Cycle 1 Pre-dose |
|
| ||||
| Cycle 1 End of infusion |
|
| ||||
| Cycle 1 5 hour post-dose |
|
| ||||
| Cycle 2 Pre-dose |
|
| ||||
| Cycle 2 End of infusion |
|
| ||||
| Cycle 3 Pre-dose |
|
| ||||
| Cycle 3 End of infusion |
|
| ||||
| Cycle 4 Pre-dose |
|
| ||||
| Cycle 4 End of infusion |
|
| ||||
| Cycle 6 Pre-dose |
|
| ||||
| Cycle 8 Pre-dose |
|
|
|