Trial Outcomes & Findings for Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 2 (NCT NCT06790303)
NCT ID: NCT06790303
Last Updated: 2025-06-04
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).
TERMINATED
PHASE2
8 participants
Up to 29 weeks
2025-06-04
Participant Flow
This is a sub-study of the master study NCT03739710. This sub study was terminated due to low enrolment of participants. The study was planned to include two phases - Part 1 and Part 2. No participants from this sub study were enrolled in part 2 as study was early terminated.
Participant milestones
| Measure |
Feladilimab + Ipilimumab
Participants with Non-Small Cell Lung Cancer (NSCLC) received 24 milligram (mg) Feladilimab first as a 30-minute intravenous (IV) infusion followed by 1 mg/ kilogram (kg) Ipilimumab as IV infusion (started at least 30 minutes following the end of the feladilimab) once every 3 weeks (Q3W).
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|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Feladilimab + Ipilimumab
Participants with Non-Small Cell Lung Cancer (NSCLC) received 24 milligram (mg) Feladilimab first as a 30-minute intravenous (IV) infusion followed by 1 mg/ kilogram (kg) Ipilimumab as IV infusion (started at least 30 minutes following the end of the feladilimab) once every 3 weeks (Q3W).
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|---|---|
|
Overall Study
Study Terminated by sponsor
|
4
|
|
Overall Study
Death
|
4
|
Baseline Characteristics
Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 2
Baseline characteristics by cohort
| Measure |
Feladilimab + Ipilimumab
n=8 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) received 24 milligram (mg) Feladilimab first as a 30-minute intravenous (IV) infusion followed by 1 mg/ kilogram (kg) Ipilimumab as IV infusion (started at least 30 minutes following the end of the feladilimab) once every 3 weeks (Q3W).
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|---|---|
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Age, Customized
18 to 84 years
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
All other races
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8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 29 weeksPopulation: Safety Population included all participants who received at least one dose of treatment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).
Outcome measures
| Measure |
Feladilimab + Ipilimumab
n=8 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) received 24 milligram (mg) Feladilimab first as a 30-minute intravenous (IV) infusion followed by 1 mg/ kilogram (kg) Ipilimumab as IV infusion (started at least 30 minutes following the end of the feladilimab) once every 3 weeks (Q3W).
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|---|---|
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Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AE
|
8 Participants
|
|
Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAE
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 21 daysPopulation: Safety Population
Criteria for dose-limiting toxicity (DLT) included hematologic indicators such as febrile neutropenia as defined by CTCAE v5; Grade 4 neutropenia of \>7 days in duration; Grade 4 anemia and Grade 3-4 thrombocytopenia with bleeding. Non-hematologic criteria, comprising Grade 4 toxicity; Grade 3 pneumonitis of any duration; Grade 3 toxicity that does not resolve to ≤Grade 1 or baseline within 3 days despite optimal supportive care; any Grade 2 ocular toxicity requiring systemic steroids, or any ≥ Grade 3 ocular toxicity Any other toxicity considered to be dose-limiting that occurs beyond four weeks was considered as DLT. Any other event which in the judgment of the investigator and GSK Medical Monitor is considered to be a DLT.
Outcome measures
| Measure |
Feladilimab + Ipilimumab
n=8 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) received 24 milligram (mg) Feladilimab first as a 30-minute intravenous (IV) infusion followed by 1 mg/ kilogram (kg) Ipilimumab as IV infusion (started at least 30 minutes following the end of the feladilimab) once every 3 weeks (Q3W).
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|---|---|
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Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to 29 weeksPopulation: Safety Population
Blood samples were collected for evaluation of hematology parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Outcome measures
| Measure |
Feladilimab + Ipilimumab
n=8 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) received 24 milligram (mg) Feladilimab first as a 30-minute intravenous (IV) infusion followed by 1 mg/ kilogram (kg) Ipilimumab as IV infusion (started at least 30 minutes following the end of the feladilimab) once every 3 weeks (Q3W).
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|---|---|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Lymphocytes, Decrease to Low
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Hematocrit, Change to Normal or No Change
|
8 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Eosinophils, Change to Normal or No Change
|
7 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Basophils, Decrease to Low
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Basophils, Change to Normal or No Change
|
8 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Basophils, Increase to High
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Eosinophils, Decrease to Low
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Eosinophils, Increase to High
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Erythrocytes, Decrease to Low
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Erythrocytes, Change to Normal or No Change
|
6 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Erythrocytes, Increase to High
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Hemoglobin, Decrease to Low
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Hemoglobin, Change to Normal or No Change
|
8 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Hemoglobin, Increase to High
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Ery. Mean Corpuscular HGB Concentration (EMCHC), Decrease to Low
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
EMCHC, Change to Normal or No Change
|
7 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
EMCHC, Increase to High
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Ery. Mean Corpuscular Hemoglobin (EMCH), Decrease to Low
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
EMCH, Change to Normal or No Change
|
7 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
EMCH, Increase to High
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Ery. Mean Corpuscular Volume (EMCV), Decrease to Low
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
EMCV, Change to Normal or No Change
|
7 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
EMCV, Increase to High
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Hematocrit, Decrease to Low
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Hematocrit, Increase to High
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Leukocytes, Decrease to Low
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Leukocytes, Change to Normal or No Change
|
7 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Leukocytes, Increase to High
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Lymphocytes, Change to Normal or No Change
|
8 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Lymphocytes, Increase to High
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Monocytes, Decrease to Low
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Monocytes, Change to Normal or No Change
|
7 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Monocytes, Increase to High
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Neutrophils, Decrease to Low
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Neutrophils, Change to Normal or No Change
|
6 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Neutrophils, Increase to High
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Platelets, Decrease to Low
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Platelets, Change to Normal or No Change
|
6 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Platelets, Increase to High
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to 29 weeksPopulation: Safety Population. Only those participants with data available in specified categories have been analyzed.
Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Outcome measures
| Measure |
Feladilimab + Ipilimumab
n=8 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) received 24 milligram (mg) Feladilimab first as a 30-minute intravenous (IV) infusion followed by 1 mg/ kilogram (kg) Ipilimumab as IV infusion (started at least 30 minutes following the end of the feladilimab) once every 3 weeks (Q3W).
|
|---|---|
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Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Aspartate Aminotransferase (AST), Decrease to Low
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Protein, Decrease to Low
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Protein, Change to Normal or No Change
|
7 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Protein, Increase to High
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Alanine aminotransferase (ALT), Decrease to Low
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
ALT, Change to Normal or No Change
|
6 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
ALT, Increase to High
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Albumin, Decrease to Low
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Albumin, Change to Normal or No Change
|
6 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Albumin, Increase to High
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Alkaline Phosphatase (AP), Decrease to Low
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
AP, Change to Normal or No Change
|
8 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
AP, Increase to High
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
AST, Change to Normal or No Change
|
8 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
AST, Increase to High
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Bilirubin, Decrease to Low
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Bilirubin, Change to Normal or No Change
|
8 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Bilirubin, Increase to High
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
C Reactive Protein (mg/L), Decrease to Low
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
C Reactive Protein, Change to Normal or No Change
|
3 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
C Reactive Protein, Increase to High
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Calcium, Decrease to Low
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Calcium, Change to Normal or No Change
|
7 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Calcium, Increase to High
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Creatinine, Decrease to Low
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Creatinine, Change to Normal or No Change
|
6 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Creatinine, Increase to High
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Glucose, Decrease to Low
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Glucose, Change to Normal or No Change
|
7 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Glucose, Increase to High
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Lactate Dehydrogenase (LDH), Decrease to Low
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
LDH, Change to Normal or No Change
|
8 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
LDH, Increase to High
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Potassium, Decrease to Low
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Potassium, Change to Normal or No Change
|
7 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Potassium, Increase to High
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Sodium, Decrease to Low
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Sodium, Change to Normal or No Change
|
7 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Sodium, Increase to High
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Thyrotropin, Decrease to Low
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Thyrotropin, Change to Normal or No Change
|
5 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Thyrotropin, Increase to High
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Triiodothyronine, Free, Decrease to Low
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Triiodothyronine, Free, Change to Normal or No Change
|
3 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Triiodothyronine, Free, Increase to High
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Troponin T, Decrease to Low
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Troponin T, Change to Normal or No Change
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Troponin T, Increase to High
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Urea, Decrease to Low
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Urea, Change to Normal or No Change
|
3 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Urea, Increase to High
|
5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to 29 weeksPopulation: Safety Population. Only those participants with data available in specified categories have been analyzed.
Urine samples were collected for evaluation of urinalysis parameters using dipstick method. The dipstick test gave results in a semi-quantitative manner. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'Any increase', or 'no changes/decreased' values have been presented.
Outcome measures
| Measure |
Feladilimab + Ipilimumab
n=6 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) received 24 milligram (mg) Feladilimab first as a 30-minute intravenous (IV) infusion followed by 1 mg/ kilogram (kg) Ipilimumab as IV infusion (started at least 30 minutes following the end of the feladilimab) once every 3 weeks (Q3W).
|
|---|---|
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Part 1: Number of Participants With Worst Case Change Post-baseline in Urinalysis Parameters
Protein, No Change/Decreased
|
3 Participants
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Urinalysis Parameters
Occult Blood, No Change/Decreased
|
6 Participants
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Urinalysis Parameters
Protein, Any Increase
|
3 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), week 4, week 7, week 10, week 13 and week 29 (Treatment Discontinuation)Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Urine samples were collected from participants to assess urine pH levels. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Changes from baseline in urine pH were reported.
Outcome measures
| Measure |
Feladilimab + Ipilimumab
n=6 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) received 24 milligram (mg) Feladilimab first as a 30-minute intravenous (IV) infusion followed by 1 mg/ kilogram (kg) Ipilimumab as IV infusion (started at least 30 minutes following the end of the feladilimab) once every 3 weeks (Q3W).
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|---|---|
|
Part 1: Change From Baseline in Potential of Hydrogen (pH) of Urine
Baseline (Day 1)
|
6.33 Potential of Hydrogen (pH)
Standard Deviation 0.816
|
|
Part 1: Change From Baseline in Potential of Hydrogen (pH) of Urine
WEEK 4
|
-0.80 Potential of Hydrogen (pH)
Standard Deviation 0.975
|
|
Part 1: Change From Baseline in Potential of Hydrogen (pH) of Urine
WEEK 7
|
-0.50 Potential of Hydrogen (pH)
Standard Deviation 0.707
|
|
Part 1: Change From Baseline in Potential of Hydrogen (pH) of Urine
WEEK 10
|
0.00 Potential of Hydrogen (pH)
Standard Deviation NA
Standard deviation was not estimable for single participant.
|
|
Part 1: Change From Baseline in Potential of Hydrogen (pH) of Urine
WEEK 13
|
0.50 Potential of Hydrogen (pH)
Standard Deviation NA
Standard deviation was not estimable for single participant.
|
|
Part 1: Change From Baseline in Potential of Hydrogen (pH) of Urine
WEEK 29 (Treatment Discontinuation)
|
-0.50 Potential of Hydrogen (pH)
Standard Deviation 0.866
|
PRIMARY outcome
Timeframe: Baseline (Day 1), week 4, week 7, week 10, week 13 and week 29 (Treatment Discontinuation)Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Urine samples were collected from participants to analyze urine specific gravity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Changes from baseline in specific gravity of urine were reported.
Outcome measures
| Measure |
Feladilimab + Ipilimumab
n=6 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) received 24 milligram (mg) Feladilimab first as a 30-minute intravenous (IV) infusion followed by 1 mg/ kilogram (kg) Ipilimumab as IV infusion (started at least 30 minutes following the end of the feladilimab) once every 3 weeks (Q3W).
|
|---|---|
|
Part 1: Change From Baseline in Specific Gravity of Urine
Baseline (Day 1)
|
1.0175 Kilogram per cubic meter
Standard Deviation 0.00418
|
|
Part 1: Change From Baseline in Specific Gravity of Urine
WEEK 4
|
0.0050 Kilogram per cubic meter
Standard Deviation 0.01173
|
|
Part 1: Change From Baseline in Specific Gravity of Urine
WEEK 7
|
0.0150 Kilogram per cubic meter
Standard Deviation 0.01414
|
|
Part 1: Change From Baseline in Specific Gravity of Urine
WEEK 10
|
0.0000 Kilogram per cubic meter
Standard Deviation NA
Standard deviation was not estimable for single participant
|
|
Part 1: Change From Baseline in Specific Gravity of Urine
WEEK 13
|
0.0250 Kilogram per cubic meter
Standard Deviation NA
Standard deviation was not estimable for single participant.
|
|
Part 1: Change From Baseline in Specific Gravity of Urine
WEEK 29 (Treatment Discontinuation)
|
0.0017 Kilogram per cubic meter
Standard Deviation 0.00764
|
PRIMARY outcome
Timeframe: Up to 29 weeksPopulation: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. The number of participants who experienced AE leading to dose modifications were evaluated.
Outcome measures
| Measure |
Feladilimab + Ipilimumab
n=8 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) received 24 milligram (mg) Feladilimab first as a 30-minute intravenous (IV) infusion followed by 1 mg/ kilogram (kg) Ipilimumab as IV infusion (started at least 30 minutes following the end of the feladilimab) once every 3 weeks (Q3W).
|
|---|---|
|
Part 1: Number of Participants With AE Leading to Dose Modifications
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 29 weeksPopulation: No participants were enrolled in Part 2 as study was terminated.
OS is defined as the time from randomization until death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: Safety Population
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or confirmed partial response (PR) as their best overall response (BOR) recorded from the date of randomization until disease progression or initiation of new anti-cancer therapy, whichever is earlier based on blinded independent central review (BICR) evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeter in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters (e.g., percent change from baseline).
Outcome measures
| Measure |
Feladilimab + Ipilimumab
n=8 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) received 24 milligram (mg) Feladilimab first as a 30-minute intravenous (IV) infusion followed by 1 mg/ kilogram (kg) Ipilimumab as IV infusion (started at least 30 minutes following the end of the feladilimab) once every 3 weeks (Q3W).
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|---|---|
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Part 1: Overall Response Rate (ORR)
Complete response
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Part 1: Overall Response Rate (ORR)
Partial response
|
0 Percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: Safety population. No participants had CR, PR, and SD.
DCR was defined as the percentage of participants with a confirmed CR + PR at any time, plus stable disease (SD) \>=12 weeks. PR was defined as at least 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 mm. Stable Disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: PK Population included all participants from the ITT Population from whom a blood sample is obtained and analyzed for PK concentration. As a result of the study termination, none of the participants had sufficient samples for analysis. Consequently, data was neither collected nor analyzed, and data will never be analyzed for this outcome measure in the future.
Blood samples were collected for PK analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 12 and 18 monthsPopulation: No participants were enrolled in Part 2 as study was terminated.
Milestone survival rate is the proportion of participants who are alive at a specific, predefined point in time after a certain event or diagnosis post treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: No participants were enrolled in Part 2 as study was terminated.
Complete Response \[CR\], Partial Response \[PR\], stable disease \[SD\], and progressive disease (PD) as assessed by the investigator per IMWG. CR defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 mm; PR was defined as at least 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Stable Disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. PD 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: No participants were enrolled in Part 2 as study was terminated.
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 to be 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: No participants were enrolled in Part 2 as study was terminated.
PFS defined as time from the date of randomization to the date of disease progression or death, whichever will occurs earlier, per RECIST criteria. ORR defined as the percentage of participants with a confirmed CR or PR at any time per RECIST criteria. DOR defined as the time from first documented evidence of CR or PR until disease progression or death, per RECIST criteria. DCR was defined as the percentage of participants with a confirmed CR + PR at any time, plus stable disease (SD) \>=12 weeks.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: No participants were enrolled in Part 2 as study was terminated.
iPFS defined as time from the date of randomization to the date of disease progression or death, whichever will occurs earlier, per iRECIST criteria. iORR defined as the percentage of participants with a confirmed iCR or iPR at any time per iRECIST criteria. iDOR defined as the time from first documented evidence of CR or PR until disease progression or death, per iRECIST criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: No participants were enrolled in Part 2 as study was terminated.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. AEs and SAEs were planned to be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: No participants were enrolled in Part 2 as study was terminated.
Number of participants with AESI were planned to be evaluated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: No participants were enrolled in Part 2 as study was terminated.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. AEs and SAEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system. Number of participants with AEs and SAEs leading to dose modification (delays/withdrawal) were planned to be evaluated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: No participants were enrolled in Part 2 as study was terminated.
Blood samples were to be collected for the analysis of hematology parameters. The laboratory parameters were to be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe or medically significant. Higher grade indicates greater severity and an increase in CTCAE grade were to be defined relative to the Baseline grade.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: No participants were enrolled in Part 2 as study was terminated.
Blood samples were to be collected for the analysis of chemistry parameters. The laboratory parameters were to be graded according to CTCAE version 5. G1: mild; G2: moderate; G3: severe or medically significant. Higher grade indicates greater severity and an increase in CTCAE grade were to be defined relative to the Baseline grade.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: No participants were enrolled in Part 2 as study was terminated.
Vital signs were planned to be measured after 5 minutes of rest and taken in the same position throughout the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: No participants were enrolled in Part 2 as study was terminated.
Blood samples were planned to be collected for PK analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: No participants were enrolled in Part 2 as study was terminated.
Serum samples were to be collected for the analysis of the presence of ADAs using validated immunoassays.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 29 weeksPopulation: No participants were enrolled in Part 2 as study was terminated.
Serum samples were to be collected for the analysis of the presence of ADAs using validated immunoassays.
Outcome measures
Outcome data not reported
Adverse Events
Feladilimab + Ipilimumab
Serious adverse events
| Measure |
Feladilimab + Ipilimumab
n=8 participants at risk
Participants with Non-Small Cell Lung Cancer (NSCLC) received 24 milligram (mg) Feladilimab first as a 30-minute intravenous (IV) infusion followed by 1 mg/ kilogram (kg) Ipilimumab as IV infusion (started at least 30 minutes following the end of the feladilimab) once every 3 weeks (Q3W).
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|---|---|
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General disorders
Pyrexia
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
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Infections and infestations
Pneumonia staphylococcal
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
|
Injury, poisoning and procedural complications
Overdose
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
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Nervous system disorders
Spinal cord compression
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
|
Nervous system disorders
Subacute inflammatory demyelinating polyneuropathy
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
|
Psychiatric disorders
Confusional state
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
Other adverse events
| Measure |
Feladilimab + Ipilimumab
n=8 participants at risk
Participants with Non-Small Cell Lung Cancer (NSCLC) received 24 milligram (mg) Feladilimab first as a 30-minute intravenous (IV) infusion followed by 1 mg/ kilogram (kg) Ipilimumab as IV infusion (started at least 30 minutes following the end of the feladilimab) once every 3 weeks (Q3W).
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
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Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
2/8 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
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Blood and lymphatic system disorders
Lymphopenia
|
12.5%
1/8 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
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Gastrointestinal disorders
Abdominal pain
|
25.0%
2/8 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
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Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
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General disorders
General physical health deterioration
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
|
Infections and infestations
Bronchitis
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
|
Infections and infestations
Oral fungal infection
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
|
Infections and infestations
Pneumonia klebsiella
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
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Metabolism and nutrition disorders
Hypercalcaemia
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
2/8 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
|
Nervous system disorders
Cerebellar ataxia
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
|
Nervous system disorders
Memory impairment
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
|
Nervous system disorders
Nervous system disorder
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
|
Psychiatric disorders
Confusional state
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
|
Psychiatric disorders
Psychomotor retardation
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER