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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001316-29 | EudraCT Number |
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| Name | Class |
|---|---|
| iTeos Belgium SA | INDUSTRY |
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This study is a sub-study of the master protocol 205801 (NCT03739710). This sub study has assessed the clinical activity of novel regimen (Feladilimab plus Docetaxel) with SOC (Docetaxel) in participants with NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel | Active Comparator |
| |
| Feladilimab plus Docetaxel | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel was administered as IV infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival was calculated as time from randomization to death. Confidence Intervals estimated using the Brookmeyer Crowley method. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier Estimates of Overall Survival at 12 and 18 Months | Overall survival was defined as the time between date of randomization and death due to any cause. Kaplan-Meier estimates of the percentage of participants who died at each time point was calculated. Confidence Intervals estimated using the Brookmeyer Crowley method. | Month 12 and 18 |
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Inclusion Criteria:
Participants capable of giving signed informed consent/assent.
Male or female, aged 18 years or older at the time consent is obtained. Participants in Korea must be age 19 years or older at the time consent is obtained.
Participants with histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous) and
a) Documented disease progression based on radiographic imaging, during or after a maximum of 2 lines of systemic treatment for locally/regionally advanced recurrent, Stage IIIb/Stage IIIc/Stage IV or metastatic disease. Two components of treatment must have been received in the same line or as separate lines of therapy: i) No more than or less than 1 line of platinum-containing chemotherapy regimen, and ii) No more than or less than 1 line of Programmed cell death ligand 1 (PD[L]1) monoclonal antibody (mAb) containing regimen.
b) Participants with known BRAF molecular alterations must have had disease progression after receiving the locally available SoC treatment for the molecular alteration.
c) Participants who received prior anti-PD(L)1 therapy must fulfill the following requirements: i) Have achieved a CR, PR or SD and subsequently had disease progression (per RECIST 1.1 criteria) either on or after completing PD(L)1 therapy ii) Have not progressed or recurred within the first 12 weeks of PD(L)1 therapy, either clinically or per RECIST 1.1 criteria
Measurable disease, presenting with at least 1 measurable lesion per RECIST 1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
A tumor tissue sample obtained at any time from the initial diagnosis of NSCLC to time of study entry is mandatory. Although a fresh tumor tissue sample obtained during screening is preferred, archival tumor specimen is acceptable.
Adequate organ function as defined in the protocol.
A male participant must agree to use a highly effective contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions apply:
i) Not a woman of childbearing potential (WOCBP) or ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
Life expectancy of at least 12 weeks.
Exclusion Criteria:
Participants who received prior treatment with the following therapies (calculation is based on date of last therapy to date of first dose of study treatment):
Received greater than (>)2 prior lines of therapy for NSCLC, including participants with BRAF molecular alternations.
Invasive malignancy or history of invasive malignancy other than disease under study within the last 2 years, except
Carcinomatous meningitis (regardless of clinical status) and uncontrolled or symptomatic Central nervous system (CNS) metastases.
Major surgery less than or equal to (<=) 28 days of first dose of study treatment.
Autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years. Replacement therapies which include physiological doses of corticosteroids for treatment of endocrinopathies (for example, adrenal insufficiency) are not considered systemic treatments.
Receiving systemic steroids (>10 milligrams [mg]) oral prednisone or equivalent) or other immunosuppressive agents within 7 days prior to first dose of study treatment.
Prior allogeneic/autologous bone marrow or solid organ transplantation.
Receipt of any live vaccine within 30 days prior to first dose of study treatment.
Toxicity from previous anticancer treatment that includes:
History (current and past) of idiopathic pulmonary fibrosis, pneumonitis (for past- pneumonitis exclusion only if steroids were required for treatment), interstitial lung disease, or organizing pneumonia.
Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions.
Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess.
History or evidence of cardiac abnormalities within the 6 months prior to enrollment which include
Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypo-albuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
Active infection requiring systemic therapy <=7 days prior to first dose of study treatment.
Participants with known human immunodeficiency virus infection.
Participants with history of severe hypersensitivity to mAb or hypersensitivity to any of the study treatment(s) or their excipients.
Participants requiring ongoing therapy with a medication that is a strong inhibitor or inducer of the cytochrome P 3A4 (CYP3A4) enzymes.
Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other condition that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator.
Pregnant or lactating female participants.
Participant who is currently participating in or has participated in a study of an investigational device within 4 weeks prior to the first dose of study treatment.
Participants with presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention.
Participants with positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
Participants with positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment.
Receipt of transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor, and recombinant erythropoietin) within 14 days before the first dose of study intervention.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | St Louis | Missouri | 63110-1093 | United States | ||
| GSK Investigational Site |
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Docetaxel 75 mg/m^2 | Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion once every 3 weeks (Q3W). |
| FG001 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 |
| 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 | May 23, 2022 | Nov 4, 2022 |
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| Feladilimab | Drug | Feladilimab was administered as IV infusion. |
|
| Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD) or Not Evaluable | CR, PR, SD and PD will be evaluated as per RECIST version 1.1 criteria. Complete Response (CR) was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm. | Up to 2 years |
| Kaplan-Meier Estimates of Progression-Free Survival (PFS) | PFS is defined as time from the date of randomization to the date of disease progression as per RECIST v1.1. or death whichever occurs earlier. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm. Confidence Intervals estimated using the Brookmeyer Crowley method. | Up to 2 years |
| Objective Response Rate | ORR was calculated as the percentage of participants with a confirmed complete response (CR) or partial response (PR) relative to the total number of participants in the analysis population per response evaluation criteria in solid tumors (RECIST) version (v)1.1. Complete Response (CR) was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. | Up to 2 years |
| Kaplan-Meier Estimates of Duration of Response (DOR) in Participants With Objective Response | DOR is defined as the time for first documented evidence of CR or PR until disease progression or death, per RECIST 1.1 criteria. Complete Response (CR) was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Confidence Intervals estimated using the Brookmeyer Crowley method. | Up to 2 years |
| Disease Control Rate (DCR) | DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =>12 weeks as per RECIST v1.1. Complete Response (CR) was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. | Up to 2 years |
| Number of Participants With iRECIST Complete Response (iCR), Partial Response (iPR), Unconfirmed Progressive Disease (iUPD), Confirmed Progressive Disease (iCPD), Stable Disease (iSD) or Not Evaluable | Modified RECIST 1.1 for immune-based therapeutics (iRECIST) is based on RECIST v 1.1 but adapted to account for the unique tumor response seen with immunotherapeutic drugs. iRECIST was used to assess tumor response and progression and make treatment decisions. iCR: disappearance of all target lesions; iPR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). iCPD: either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; iSD: stable disease in the absence of CR or PD and iUPD: unconfirmed progressive disease when PD is unconfirmed and NE: not evaluable. | Up to 2 years |
| Kaplan-Meier Estimates of iRECIST Progression-free Survival (iPFS) | iPFS is defined as time from the date of randomization to the date of disease progression or death, whichever occurs earlier, per iRECIST criteria. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm. Confidence Intervals estimated using the Brookmeyer Crowley method. | Up to 2 years |
| iRECIST Objective Response Rate (iORR) | iORR is defined as the percentage of participants with a confirmed iCR or iPR at any time per iRECIST criteria. iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. | Up to 2 years |
| Kaplan-Meier Estimates of iRECIST Duration of Response (iDOR) in Participants With Objective Response | iDOR is defined as the time from first documented evidence of CR or PR until disease progression or death, per iRECIST criteria. iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Confidence Intervals estimated using the Brookmeyer Crowley method. | Up to 2 years |
| Number of Participants With AEs, Adverse Events of Special Interest (AESI), SAEs and AE/SAEs Leading to Dose Modifications/Delays/Withdrawals | An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement. AESI are considered to be Infusion Related Reactions (IRRs) and those of potential immunologic etiology. | Up to 2 years |
| Number of Participants With Maximum Grade Increase in Clinical Chemistry Parameters at Worst Case Post-Baseline | Blood samples were collected for assessment of the clinical chemistry parameters. Laboratory grades were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE. Number of participants with clinical chemistry results by maximum grade increase (Increase to Grade 3 or Increase to Grade 4) are presented. | Up to 2 years |
| Number of Participants With Maximum Grade Increase in Hematology Parameters at Worst Case Post-Baseline | Blood samples were collected for assessment of the hematology parameters. Laboratory grades were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE. Number of participants with Hematology results by maximum grade increase (Increase to Grade 3 or Increase to Grade 4) are presented. | Up to 2 years |
| Number of Participants With Maximum Grade Increase in Vital Signs (Systolic Blood Pressure and Diastolic Blood Pressure) Parameters at Worst Case Post-Baseline | Blood Pressure was measured after 5 minutes of rest and was taken in the same position throughout the study. Laboratory grades were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE. Number of participants with vital signs results by maximum grade increase (Increase to Grade 2 or Increase to Grade 3) are presented. | Up to 2 years |
| Number of Participants With Vital Signs (Temperature) Parameter Results at Worst Case Post-Baseline | Body temperature was measured after 5 minutes of rest. Results are presented in the following categories: Decrease to <=35 Degrees Celsius, Change to Normal or No Change and Increase to >=38 Degrees Celsius. | Up to 2 years |
| Number of Participants With Vital Signs (Pulse Rate) Parameter Results at Worst Case Post-Baseline | Pulse Rate was measured after 5 minutes of rest. Results are presented in the following categories: Decrease to <50 beats per minute, Change to Normal or No Change and Increase to >120 beats per minute. | Up to 2 years |
| Minimum Observed Concentration (CmIn) of Feladilimab | Blood samples were collected for assessment of the pharmacokinetic parameters. | Week 1 |
| Maximum Observed Concentration (Cmax) of Feladilimab | Blood samples were collected for assessment of the pharmacokinetic parameters. | Week 1, Week 13 and Week 25 |
| Maximum Observed Concentration (Cmax) of Docetaxel | Blood samples were collected for assessment of the pharmacokinetic parameters. | Week 1, Week 4, Week 7, Week 10, Week 13, Week 16, Week 19 and Week 22 |
| Number of Participants With Positive Anti-drug Antibodies (ADA) Against Docetaxel | Up to 2 years |
| Number of Participants With Positive ADA Against Feladilimab | Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 37, 49, 61 and 73 |
| Nashville |
| Tennessee |
| 37203 |
| United States |
| GSK Investigational Site | Dallas | Texas | 75230 | United States |
| GSK Investigational Site | Toronto | Ontario | M5G 2M9 | Canada |
| GSK Investigational Site | Bordeaux | 33076 | France |
| GSK Investigational Site | Caen | 14033 | France |
| GSK Investigational Site | Nantes | 44093 | France |
| GSK Investigational Site | Paris | 75018 | France |
| GSK Investigational Site | Paris | 75248 | France |
| GSK Investigational Site | Villejuif | 94805 | France |
| GSK Investigational Site | Gauting | Bavaria | Germany |
| GSK Investigational Site | Immenhausen | Hesse | 34376 | Germany |
| GSK Investigational Site | Leipzig | Saxony | Germany |
| GSK Investigational Site | Großhansdorf | Schleswig-Holstein | 22927 | Germany |
| GSK Investigational Site | Berlin | 14165 | Germany |
| GSK Investigational Site | Meldola (FC) | Emilia-Romagna | 47014 | Italy |
| GSK Investigational Site | Ravenna | Emilia-Romagna | 48121 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20133 | Italy |
| GSK Investigational Site | Orbassano (TO) | Piedmont | 10043 | Italy |
| GSK Investigational Site | Maastricht | 6229 HX | Netherlands |
| GSK Investigational Site | Lodz | 93-513 | Poland |
| GSK Investigational Site | Poznan | 60-569 | Poland |
| GSK Investigational Site | Warsaw | 02-781 | Poland |
| GSK Investigational Site | Bucharest | 020142 | Romania |
| GSK Investigational Site | Craiova | 200347 | Romania |
| GSK Investigational Site | Floreşti | 407280 | Romania |
| GSK Investigational Site | Otopeni | 075100 | Romania |
| GSK Investigational Site | Timișoara | 300166 | Romania |
| GSK Investigational Site | Chelyabinsk | 454048 | Russia |
| GSK Investigational Site | Saint Petersburg | 194291 | Russia |
| GSK Investigational Site | Saint Petersburg | 197183 | Russia |
| GSK Investigational Site | Cheongju-si | 28644 | South Korea |
| GSK Investigational Site | Gyeonggi-do | 10408 | South Korea |
| GSK Investigational Site | Seongnam | 13620 | South Korea |
| GSK Investigational Site | Seoul | 05505 | South Korea |
| GSK Investigational Site | Barcelona | 08035 | Spain |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | Madrid | 28027 | Spain |
| GSK Investigational Site | Madrid | 28033 | Spain |
| GSK Investigational Site | Madrid | Spain |
| GSK Investigational Site | Santander | 39008 | Spain |
| GSK Investigational Site | Seville | 41009 | Spain |
| GSK Investigational Site | Uppsala | SE- 75 185 | Sweden |
Participants with NSCLC were administered with Feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Docetaxel 75 mg/m^2 | Participants with NSCLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion once every 3 weeks (Q3W). |
| BG001 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 | Participants with NSCLC were administered with Feladilimab 80 mg IV infusion Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | |||||||||||||||||||||||
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| Primary | Overall Survival | Overall survival was calculated as time from randomization to death. Confidence Intervals estimated using the Brookmeyer Crowley method. | Intent To Treat population (ITT) included all participants who were randomized to treatment regardless of whether the participants actually received study treatment. | Posted | Median | 95% Confidence Interval | Months | Up to 2 years |
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| Secondary | Kaplan-Meier Estimates of Overall Survival at 12 and 18 Months | Overall survival was defined as the time between date of randomization and death due to any cause. Kaplan-Meier estimates of the percentage of participants who died at each time point was calculated. Confidence Intervals estimated using the Brookmeyer Crowley method. | Intent-To-Treat Population. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 12 and 18 |
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| Secondary | Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD) or Not Evaluable | CR, PR, SD and PD will be evaluated as per RECIST version 1.1 criteria. Complete Response (CR) was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm. | Intent-To-Treat Population. | Posted | Count of Participants | Participants | Up to 2 years |
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| Secondary | Kaplan-Meier Estimates of Progression-Free Survival (PFS) | PFS is defined as time from the date of randomization to the date of disease progression as per RECIST v1.1. or death whichever occurs earlier. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm. Confidence Intervals estimated using the Brookmeyer Crowley method. | Intent to Treat Population. Only those participants with data available at specified data points have been analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to 2 years |
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| Secondary | Objective Response Rate | ORR was calculated as the percentage of participants with a confirmed complete response (CR) or partial response (PR) relative to the total number of participants in the analysis population per response evaluation criteria in solid tumors (RECIST) version (v)1.1. Complete Response (CR) was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. | Intent-To-Treat Population | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 2 years |
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| Secondary | Kaplan-Meier Estimates of Duration of Response (DOR) in Participants With Objective Response | DOR is defined as the time for first documented evidence of CR or PR until disease progression or death, per RECIST 1.1 criteria. Complete Response (CR) was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Confidence Intervals estimated using the Brookmeyer Crowley method. | Intent To Treat Population. Only participants who achieved Objective Response were evaluated. | Posted | Median | 95% Confidence Interval | Months | Up to 2 years |
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| Secondary | Disease Control Rate (DCR) | DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =>12 weeks as per RECIST v1.1. Complete Response (CR) was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. | Intent-to-Treat Population. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 2 years |
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| Secondary | Number of Participants With iRECIST Complete Response (iCR), Partial Response (iPR), Unconfirmed Progressive Disease (iUPD), Confirmed Progressive Disease (iCPD), Stable Disease (iSD) or Not Evaluable | Modified RECIST 1.1 for immune-based therapeutics (iRECIST) is based on RECIST v 1.1 but adapted to account for the unique tumor response seen with immunotherapeutic drugs. iRECIST was used to assess tumor response and progression and make treatment decisions. iCR: disappearance of all target lesions; iPR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). iCPD: either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; iSD: stable disease in the absence of CR or PD and iUPD: unconfirmed progressive disease when PD is unconfirmed and NE: not evaluable. | Intent-To-Treat Population. | Posted | Count of Participants | Participants | Up to 2 years |
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| Secondary | Kaplan-Meier Estimates of iRECIST Progression-free Survival (iPFS) | iPFS is defined as time from the date of randomization to the date of disease progression or death, whichever occurs earlier, per iRECIST criteria. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm. Confidence Intervals estimated using the Brookmeyer Crowley method. | Intent-to-Treat population. Only those participants with data available at specified data points have been analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to 2 years |
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| Secondary | iRECIST Objective Response Rate (iORR) | iORR is defined as the percentage of participants with a confirmed iCR or iPR at any time per iRECIST criteria. iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. | Intent-to-Treat population. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 2 years |
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| Secondary | Kaplan-Meier Estimates of iRECIST Duration of Response (iDOR) in Participants With Objective Response | iDOR is defined as the time from first documented evidence of CR or PR until disease progression or death, per iRECIST criteria. iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Confidence Intervals estimated using the Brookmeyer Crowley method. | Intent-To-Treat Population. Only the participants with Objective Response were evaluated. | Posted | Median | 95% Confidence Interval | Months | Up to 2 years |
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| Secondary | Number of Participants With AEs, Adverse Events of Special Interest (AESI), SAEs and AE/SAEs Leading to Dose Modifications/Delays/Withdrawals | An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement. AESI are considered to be Infusion Related Reactions (IRRs) and those of potential immunologic etiology. | Safety Population included all the randomized participants who received at least one dose of Standard of Care (SoC), or experimental regimen based on actual treatment received. | Posted | Count of Participants | Participants | Up to 2 years |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Maximum Grade Increase in Clinical Chemistry Parameters at Worst Case Post-Baseline | Blood samples were collected for assessment of the clinical chemistry parameters. Laboratory grades were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE. Number of participants with clinical chemistry results by maximum grade increase (Increase to Grade 3 or Increase to Grade 4) are presented. | Safety Population. Only those participants with data available at specified data points have been analyzed. | Posted | Count of Participants | Participants | Up to 2 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Maximum Grade Increase in Hematology Parameters at Worst Case Post-Baseline | Blood samples were collected for assessment of the hematology parameters. Laboratory grades were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE. Number of participants with Hematology results by maximum grade increase (Increase to Grade 3 or Increase to Grade 4) are presented. | Safety Population. Only those participants with data available at specified data points have been analyzed. | Posted | Count of Participants | Participants | Up to 2 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Maximum Grade Increase in Vital Signs (Systolic Blood Pressure and Diastolic Blood Pressure) Parameters at Worst Case Post-Baseline | Blood Pressure was measured after 5 minutes of rest and was taken in the same position throughout the study. Laboratory grades were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE. Number of participants with vital signs results by maximum grade increase (Increase to Grade 2 or Increase to Grade 3) are presented. | Safety Population. Only those participants with data available at specified time points have been analyzed. | Posted | Count of Participants | Participants | Up to 2 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Vital Signs (Temperature) Parameter Results at Worst Case Post-Baseline | Body temperature was measured after 5 minutes of rest. Results are presented in the following categories: Decrease to <=35 Degrees Celsius, Change to Normal or No Change and Increase to >=38 Degrees Celsius. | Safety Population. Only those participants with data available at specified data points have been analyzed. | Posted | Count of Participants | Participants | Up to 2 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Vital Signs (Pulse Rate) Parameter Results at Worst Case Post-Baseline | Pulse Rate was measured after 5 minutes of rest. Results are presented in the following categories: Decrease to <50 beats per minute, Change to Normal or No Change and Increase to >120 beats per minute. | Safety Population. Only those participants with data available at specified data points have been analyzed. | Posted | Count of Participants | Participants | Up to 2 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Minimum Observed Concentration (CmIn) of Feladilimab | Blood samples were collected for assessment of the pharmacokinetic parameters. | Pharmacokinetic (PK) population will consist of all participants from the ITT Population from whom a blood sample was obtained and analyzed for PK concentration. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per millimeter (ng/mL) | Week 1 |
|
| |||||||||||||||||||||||||||||
| Secondary | Maximum Observed Concentration (Cmax) of Feladilimab | Blood samples were collected for assessment of the pharmacokinetic parameters. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per millimeter (ng/mL) | Week 1, Week 13 and Week 25 |
|
| |||||||||||||||||||||||||||||
| Secondary | Maximum Observed Concentration (Cmax) of Docetaxel | Blood samples were collected for assessment of the pharmacokinetic parameters. | Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per millimeter (ng/mL) | Week 1, Week 4, Week 7, Week 10, Week 13, Week 16, Week 19 and Week 22 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Anti-drug Antibodies (ADA) Against Docetaxel | Data was not collected. | Posted | Up to 2 years |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive ADA Against Feladilimab | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Count of Participants | Participants | Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 37, 49, 61 and 73 |
|
|
All cause mortality, non-SAEs and SAEs were collected up to 2 years.
Safety population included all randomized participants who received at least one dose of SoC or experimental regimen based on actual treatment received.
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 | Docetaxel 75 mg/m^2 | Participants with NSLC were administered with Docetaxel 75 milligram per meter square (mg/m^2) monotherapy as intravenous (IV) infusion once every 3 weeks (Q3W). | 25 | 34 | 16 | 34 | 31 | 34 |
| EG001 | Feladilimab 80 mg Plus Docetaxel 75 mg/m^2 | Participants with NSLC were administered with feladilimab 80 mg IV infusion once Q3W in combination with Docetaxel 75 mg/m^2 IV infusion Q3W. | 62 | 70 | 34 | 70 | 66 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Acute respiratory distress Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (25.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 8, 2021 | Nov 4, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| 65-74 |
|
| 75-84 |
|
| >=85 |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| South Korea |
|
| Netherlands |
|
| Sweden |
|
| Romania |
|
| United States |
|
| Poland |
|
| Italy |
|
| France |
|
| Germany |
|
| Spain |
|
| Russia |
|
|
|
|
| Units | Counts |
|---|
| Participants |
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| Participants |
|
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| Participants |
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| Participants |
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|
| Units |
|---|
| Counts |
|---|
| Participants |
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| Participants |
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| Participants |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Week 1 |
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| Week 4 |
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| Week 7 |
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| Week 10 |
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| Week 13 |
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| Week 16 |
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| Week 19 |
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| Week 22 |
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| Week 25 |
|
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| Week 37 |
|
| ||||
| Week 49 |
|
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| Week 61 |
|
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| Week 73 |
|
|