Trial · NCT02783300
Registered outcomes66
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 66
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 30 months | 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. A summary of number of participants with any AEs and SAEs is presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary). |
| Primary | Part 1: Number of Participants Withdrawn Due to AEs | Up to 30 months | The data for number of participants withdrawn due to AEs have been presented. |
| Primary | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Up to 21 days | DLT is considered to be clinically relevant AE by investigator if it met at least one of the criteria: Grade(G)3 neutropenia for \>=5 days/G4 neutropenia of any duration, G3 or greater febrile neutropenia, G4 or greater anemia of any duration and thrombocytopenia, or G3 thrombocytopenia with bleeding, Alanine aminotransferase (ALT) \>3x upper limit of normal (ULN)+bilirubin, \>=2xULN or ALT between 3-5 X ULN with bilirubin \< 2Xuln but with hepatitis symptoms/rash, G3 nausea/vomiting/diarrhea that does not improve within 72 hour, G4 or greater nausea/vomiting/diarrhea, G3 or greater hypertension, G3 or greater clinically significant non-hematologic toxicity per National Cancer Institute -- Common Terminology Criteria for Adverse Events (NCICTCAE), Inability to receive at least 80% of scheduled doses in the DLT observation period due to toxicity, G2 or higher toxicity that occurs beyond 21 days which in the judgment of the investigator and GSK Medical Monitor was considered to be a DLT. |
| Primary | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Up to 30 months | The number of participants who experienced any dose modifications (interruptions and reductions) of GSK3326595 have been presented. |
| Primary | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Baseline (Day 1) and up to 30 months | 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, changes to normal or no changes from Baseline, and increases to high values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. |
| Primary | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Baseline (Day 1) and up to 30 months | 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, changes to normal or no changes from Baseline, and increases to high values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. |
| Primary | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Baseline (Day 1) and up to 30 months | Blood samples were collected for evaluation of coagulation 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 v4.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. |
| Primary | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Baseline (Day 1) and up to 30 months | Urine samples were collected for evaluation of urinalysis 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 no change or change to negative and change to positive have been presented. |
| Primary | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline (Day 1) and up to week 132 | Urine samples were collected from participants to assess urine pH levels. |
| Primary | Part 1: Changes From Baseline in Urine Specific Gravity | Baseline (Day 1) and up to week 132 | Urine samples were collected from participants to assess urine specific gravity. |
| Primary | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Baseline (Day 1) and up to 30 months | The abnormal vital sign ranges are: Heart Rate:- Low (\<60 beats per minute (bpm)), Normal (\>=60 bpm to \<=100 bpm), High (\>100 bpm); Temperature:- Low (\<=35 degree Celsius (°C)), Normal (\>35 °C and \<38 °C), High (\>=38 °C); Systolic Blood Pressure:- Low (\<90 millimeter of mercury (mmHg)), Normal (\>=90 mmHg to \<120 mmHg), High (\>=120 mmHg); Diastolic Blood Pressure:- Low (\<60 mmHg), Normal (\>=60 mmHg to \<80 mmHg), High (\>=80 mmHg). Participants were counted in the worst-case category and their value changes to (low, normal or high), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. |
| Primary | Part 3: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 10 months | 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 was a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. A summary of number of participants with any AEs and SAEs is presented. AEs were coded using the MedDRA dictionary. |
| Primary | Part 3: Number of Participants Withdrawn Due to AEs | Up to 10 months | The data for number of participants withdrawn due to AEs have been presented. |
| Primary | Part 3: Number of Participants With Dose Modifications of GSK3326595 and Pembrolizumab | Up to 10 months | The number of participants who experienced any dose modifications (interruptions and reductions) of GSK3326595 and pembrolizumab have been presented. |
| Primary | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Baseline (Day 1) and up to 10 months | 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 CTCAE v5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. |
| Primary | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Baseline (Day 1) and up to 10 months | 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, changes to normal or no changes from Baseline, and increases to high values have been presented. |
| Primary | Part 3: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Baseline (Day 1) and up to 10 months | Blood samples were collected for evaluation of coagulation 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', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented. |
| Primary | Part 3: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Baseline (Day 1) and up to 10 months | Urine samples were collected for evaluation of urinalysis 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 no change or change to negative and change to positive values have been presented. |
| Primary | Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline (Day 1) and up to Week 42 | Urine samples were collected from participants to assess urine pH levels. |
| Primary | Part 3: Changes From Baseline in Urine Specific Gravity | Baseline (Day 1) and up to Week 42 | Urine samples were collected from participants to assess urine specific gravity. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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