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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003296-34 | EudraCT Number |
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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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The aim of this Phase I/IIa study is to identify a safe and tolerable dosage regimen of intravenously administered otelixizumab. In addition, the C-peptide decline in new onset type 1 diabetes mellitus (NOT1DM) patients and possible immunological mechanisms will be investigated with a view to identifying trends and early immunological biomarkers which could predict response in halting/slowing Beta-cell destruction in this patient population.
This exploratory study will explore the safety and tolerability between the well tolerated but non-efficacious cumulative dose of 3.1 mg and a cumulative dose of 48 mg at which efficacy based on C-peptide analysis was demonstrated, albeit with evidence of Epstein Barr Virus (EBV) reactivation and Cytokine Release Syndrome (CRS). Exploration of the tolerability dose response is considered a necessary first step to determining the therapeutic index of otelixizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Otelixizumab 9 mg | Experimental | Each subject will receive otelixizumab 1.5 mg diluted with 0.9% weight /volume sodium chloride intravenously daily for 6 consecutive days (cumulative dose-9 mg) |
|
| Otelixizumab 18 mg | Experimental | Each subject will receive otelixizumab 3 mg diluted with 0.9% weight /volume sodium chloride intravenously daily for 6 consecutive days (cumulative dose-18 mg) |
|
| Otelixizumab 27 mg | Experimental | Each subject will receive otelixizumab 4.5 mg diluted with 0.9% weight /volume sodium chloride intravenously daily for 6 consecutive days (cumulative dose-27 mg) |
|
| Otelixizumab 36 mg | Experimental | Each subject will receive otelixizumab 1.5 mg diluted with 0.9% weight /volume sodium chloride intravenously daily for 6 consecutive days (cumulative dose-36 mg) |
|
| Placebo | Placebo Comparator | Each subject will receive otelixizumab matching placebo diluted with 0.9% weight /volume sodium chloride intravenously daily for 6 consecutive days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Otelixizumab | Biological | Otelixizumab is available at unit dose strength of 5 milligram/mL provided as 1 mL solution per vial to be diluted to 0.1 mg/mL in 0.9% sodium chloride. The 0.1 mg/mL solution is to be administered by intravenous infusion using a syringe pump and an in-line 0.2 micron filter by study personnel following specified regimens |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) Related to Cytokine Release Syndrome (CRS) | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs have been reported. Safety Population comprised of all participants who received at least one dose of study treatment. | Up to Day 14 |
| Epstein-Barr Virus (EBV) Viral Load Detection | Blood samples were collected for analysis of EBV viral load and detection was done by polymerase chain reaction (PCR). | Week 3, Week 6, Week 8, Week 12, Week 24 and Week 96 |
| Number of Participants With Abnormal Laboratory Results | Blood samples were collected to analyze the laboratory parameters which included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bilirubin, calcium, chloride, creatinine, direct bilirubin, glucose, potassium, protein, sodium, urate, urea nitrogen, basophil, eosinophil, mean corpuscular haemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), mean corpuscular volume (MCV), erythrocytes, haematocrit, haemoglobin, leukocytes, lymphocytes, monocytes, neutrophils, platelets and reticulocytes. | Up to Month 24 |
| Number of Participants With Increase in QT Interval Corrected for Heart Rate (QTc) | 12-lead electrocardiograms (ECGs) were obtained in semi-supine position after 5 minutes rest for the participants at indicated time points to measure QTc. | Up to Month 24 |
| Number of Participants With Abnormal Vital Sign Results | Vital signs were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Vital signs included systolic, diastolic blood pressure, pulse rate and respiratory rate |
| Measure | Description | Time Frame |
|---|---|---|
| Free Serum Otelixizumab Concentrations by Treatment | Blood samples were collected at designated timepoints. Free serum Otelixizumab concentrations were calculated by linear and semi-logarithmic individual serum concentration-time profiles. Fully treated population comprised of all randomized participants who received the full 6 days of treatment based on actual exposure data. NA indicates that data could not be calculated as >30% of samples were below the limit of quantification. |
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Inclusion Criteria:
NOTE: Subjects aged 16 to 17 years must be Tanner Stage >= 2. All subjects must weigh at least 31 kg.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Brussels | 1070 | Belgium | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33145642 | Derived | Keymeulen B, van Maurik A, Inman D, Oliveira J, McLaughlin R, Gittelman RM, Roep BO, Gillard P, Hilbrands R, Gorus F, Mathieu C, Van de Velde U, Wisniacki N, Napolitano A. A randomised, single-blind, placebo-controlled, dose-finding safety and tolerability study of the anti-CD3 monoclonal antibody otelixizumab in new-onset type 1 diabetes. Diabetologia. 2021 Feb;64(2):313-324. doi: 10.1007/s00125-020-05317-y. Epub 2020 Nov 4. | |
| 30566758 |
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A total of 30 participants were enrolled at different centers in Belgium, which was conducted from 12-Mar-2014 to 27-Sep-2018.
The study was a multi-centered, single-blind, randomized, placebo-controlled 6 Day repeat dose study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, efficacy and immunological profile of intravenously administered Otelixizumab (OTX) in New Onset Type 1 Diabetes Mellitus participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days |
| FG001 | Otelixizumab 9 mg | Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days |
| FG002 | Otelixizumab 18 mg | Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days |
| FG003 | Otelixizumab 27 mg | Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Population comprised of participants who received at least one dose of study treatment. 1 participant withdrew after being randomized, prior to receiving any treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days |
| BG001 | Otelixizumab 9 mg | Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Safety Population comprised of participants who received at least one dose of study treatment. 1 participant withdrew after being randomized, prior to receiving any treatment. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) Related to Cytokine Release Syndrome (CRS) | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs have been reported. Safety Population comprised of all participants who received at least one dose of study treatment. | Safety population | Posted | Number | Participants | Up to Day 14 |
|
On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months.
Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 20, 2018 | Feb 14, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 26, 2017 | Feb 15, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D000080424 | Cytokine Release Syndrome |
| D020031 | Epstein-Barr Virus Infections |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C550701 | otelixizumab |
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|
|
| Placebo | Biological | Placebo is available 0.9% w/v sodium chloride |
|
| Up to Month 24 |
| Pre-dose on Day 1,2,3,4,5,6 and 14; 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 16 hours post-dose on Day 1, and 1 hour post-dose on Day 6. |
| Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Blood samples were collected at indicated time points to assess levels of C-peptide. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Mixed meal-stimulated C-peptide AUC was calculated from area under C-peptide/time curve from time 0 to 120 minutes, using trapezoidal rule. ITT treated population comprised of all randomized participants who received at least one dose of study treatment. | Baseline (Day-1), Month 3, Month 6, Month 12, Month 18 and Month 24 |
| Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Blood samples were collected at indicated time points to assess levels of glucose. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Mixed meal-stimulated glucose was calculated from area under the glucose /time curve from time 0 to 120 minutes, using trapezoidal rule. | Baseline (Day-1), Month 3, Month 6, Month 12, Month 18 and Month 24 |
| Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 60 to 140 Minutes, [AUC 60-140 Minutes]) From Hyperglycemic Clamp Test | Blood samples were collected at indicated time points to assess levels of C-peptide during hyperglycemic (H) phase. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from specified time point value. C-peptide AUC was calculated from area under C-peptide/time curve from time H60 to H140 minutes. | Baseline (Day-1), Month 6, Month 24 |
| Change From Baseline in Glucose Weighted Mean (Area Under Curve From 60 to 140 Minutes, AUC60-140 Minutes) From Hyperglycemic Clamp Test | Blood samples were collected at indicated time points to assess levels of glucose during hyperglycemic (H) phase. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Glucose AUC was calculated from area under the C-peptide/time curve from time H60 to H140 minutes. | Baseline (Day-1), Month 6 and Month 24 |
| Change From Baseline in Insulin Sensitivity (IS) Index From Hyperglycemic Clamp Test | Insulin sensitivity index is defined as the ratio of glucose metabolized and average insulin concentration multiplied by 100 by hyperglycemic clamp test. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Baseline (Day-1), Month 6, Month 24 |
| Change From Baseline in Mean Daily Insulin Use | Participants were asked to record their daily insulin usage thoroughly and accurately in a diary from 7 days prior to study visit. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Baseline (Day-1), Week 2, Week 3, Week 6, Week 8, Week 12, Week 24, Week 36, Week 48, Week 72 and Week 96 |
| Change From Baseline in Hemoglobin A1c | Hemoglobin A1C levels were measured at indicated time points. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Baseline (Day-1), Month 6, Month 12 and Month 24 |
| Absolute Body Weight | Body weight was measured at indicated time points. | Day-1, Month 12, Month 18 and Month 24 |
| Time-normalized Number of Hypoglycemic and Hyperglycemic Events | As per American Diabetes Association (ADA), hypoglycemia is defined as blood glucose level <= 70 milligram/deciliter (mg/dl) and hyperglycemia is defined as blood glucose level > 250 mg/dL. Hypoglycaemic and hyperglycaemic events will be recorded in a diary whenever they occur, along with the start and stop dates. Mean number of events is defined as the average number of events reported per subject. Normalization is expressed by dividing number of events by length of reporting period in month (1 month = 30 days). | Up to Month 24 |
| Relative Change From Baseline in Percentage (%) in CD4+ Cells | Whole blood samples were collected and analyzed by flow cytometry. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Relative change from Baseline (percentage) was calculated as change from Baseline relative to Baseline in percentage. | Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14 |
| Relative Change From Baseline in Percentage (%) in CD8+ Cells | Whole blood samples were collected and analyzed by flow cytometry. Day1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Relative change from baseline (%) was calculated as change from Baseline relative to Baseline in %. NA indicates that standard deviation could not be calculated for a single participant. | Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14 |
| Change From Baseline in Free CD3 on CD8+ Cells | Whole blood samples were drawn and analyzed by flow cytometry. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. NA indicates that standard deviation could not be calculated for a single participant. | Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14 |
| Change From Baseline in Free CD3 on CD4+ Cells | Whole blood samples were drawn and analyzed by flow cytometry. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. NA indicates that standard deviation could not be calculated for a single participant. | Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14 |
| Change From Baseline in Bound CD3 Copies on CD4+ Cells | Whole blood samples were drawn and analyzed by flow cytometry. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. NA indicates that standard deviation could not be calculated for a single participant. | Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14 |
| Change From Baseline in Bound CD3 Copies on CD8+ Cells | Whole blood samples were drawn and analyzed by flow cytometry. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. NA indicates that standard deviation could not be calculated for a single participant. | Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14 |
| Number of Participants With Anti-drug Antibody Binding | Samples were analyzed for the presence of anti-Otelixizumab antibodies using a validated immunoelectrochemiluminescent (ECL) assay. | Day-1, Month 3 and Month 6 |
| Brussels |
| 1090 |
| Belgium |
| GSK Investigational Site | Edegem | 2650 | Belgium |
| GSK Investigational Site | Ghent | 9000 | Belgium |
| GSK Investigational Site | Leuven | 3000 | Belgium |
| GSK Investigational Site | Liège | 4000 | Belgium |
| Derived |
| Vlasakakis G, Napolitano A, Barnard R, Brown K, Bullman J, Inman D, Keymeulen B, Lanham D, Leirens Q, MacDonald A, Mezzalana E, Page K, Patel M, Savage CO, Zamuner S, van Maurik A. Target engagement and cellular fate of otelixizumab: a repeat dose escalation study of an anti-CD3epsilon mAb in new-onset type 1 diabetes mellitus patients. Br J Clin Pharmacol. 2019 Apr;85(4):704-714. doi: 10.1111/bcp.13842. Epub 2019 Feb 5. |
| Adverse Event |
|
| Lost to Follow-up |
|
| BG002 | Otelixizumab 18 mg | Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days |
| BG003 | Otelixizumab 27 mg | Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Safety Population comprised of participants who received at least one dose of study treatment. 1 participant withdrew after being randomized, prior to receiving any treatment. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Safety Population comprised of participants who received at least one dose of study treatment. 1 participant withdrew after being randomized, prior to receiving any treatment. | Number | Count of Participants |
|
Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
| OG002 | Otelixizumab 18 mg | Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days |
| OG003 | Otelixizumab 27 mg | Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days |
|
|
| Primary | Epstein-Barr Virus (EBV) Viral Load Detection | Blood samples were collected for analysis of EBV viral load and detection was done by polymerase chain reaction (PCR). | Safety population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Geometric Mean | Geometric Coefficient of Variation | Copies per million cells | Week 3, Week 6, Week 8, Week 12, Week 24 and Week 96 |
|
|
|
| Primary | Number of Participants With Abnormal Laboratory Results | Blood samples were collected to analyze the laboratory parameters which included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bilirubin, calcium, chloride, creatinine, direct bilirubin, glucose, potassium, protein, sodium, urate, urea nitrogen, basophil, eosinophil, mean corpuscular haemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), mean corpuscular volume (MCV), erythrocytes, haematocrit, haemoglobin, leukocytes, lymphocytes, monocytes, neutrophils, platelets and reticulocytes. | Safety population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Number | Participants | Up to Month 24 |
|
|
|
| Primary | Number of Participants With Increase in QT Interval Corrected for Heart Rate (QTc) | 12-lead electrocardiograms (ECGs) were obtained in semi-supine position after 5 minutes rest for the participants at indicated time points to measure QTc. | Safety population | Posted | Number | Participants | Up to Month 24 |
|
|
|
| Primary | Number of Participants With Abnormal Vital Sign Results | Vital signs were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Vital signs included systolic, diastolic blood pressure, pulse rate and respiratory rate | Safety population | Posted | Number | Participants | Up to Month 24 |
|
|
|
| Secondary | Free Serum Otelixizumab Concentrations by Treatment | Blood samples were collected at designated timepoints. Free serum Otelixizumab concentrations were calculated by linear and semi-logarithmic individual serum concentration-time profiles. Fully treated population comprised of all randomized participants who received the full 6 days of treatment based on actual exposure data. NA indicates that data could not be calculated as >30% of samples were below the limit of quantification. | Fully Treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Nanogram per milliliter (ng/mL) | Pre-dose on Day 1,2,3,4,5,6 and 14; 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 16 hours post-dose on Day 1, and 1 hour post-dose on Day 6. |
|
|
|
| Secondary | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test | Blood samples were collected at indicated time points to assess levels of C-peptide. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Mixed meal-stimulated C-peptide AUC was calculated from area under C-peptide/time curve from time 0 to 120 minutes, using trapezoidal rule. ITT treated population comprised of all randomized participants who received at least one dose of study treatment. | Intent-To-Treat (ITT) treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Nanomoles minute per liter | Baseline (Day-1), Month 3, Month 6, Month 12, Month 18 and Month 24 |
|
|
|
| Secondary | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test | Blood samples were collected at indicated time points to assess levels of glucose. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Mixed meal-stimulated glucose was calculated from area under the glucose /time curve from time 0 to 120 minutes, using trapezoidal rule. | ITT treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Millmoles minute per liter | Baseline (Day-1), Month 3, Month 6, Month 12, Month 18 and Month 24 |
|
|
|
| Secondary | Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 60 to 140 Minutes, [AUC 60-140 Minutes]) From Hyperglycemic Clamp Test | Blood samples were collected at indicated time points to assess levels of C-peptide during hyperglycemic (H) phase. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from specified time point value. C-peptide AUC was calculated from area under C-peptide/time curve from time H60 to H140 minutes. | ITT treated population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Nanomoles minute per liter | Baseline (Day-1), Month 6, Month 24 |
|
|
|
| Secondary | Change From Baseline in Glucose Weighted Mean (Area Under Curve From 60 to 140 Minutes, AUC60-140 Minutes) From Hyperglycemic Clamp Test | Blood samples were collected at indicated time points to assess levels of glucose during hyperglycemic (H) phase. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Glucose AUC was calculated from area under the C-peptide/time curve from time H60 to H140 minutes. | ITT treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Millmoles minute per liter | Baseline (Day-1), Month 6 and Month 24 |
|
|
|
| Secondary | Change From Baseline in Insulin Sensitivity (IS) Index From Hyperglycemic Clamp Test | Insulin sensitivity index is defined as the ratio of glucose metabolized and average insulin concentration multiplied by 100 by hyperglycemic clamp test. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | ITT treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | (100*mmol*l)/(pmol*kg*min) | Baseline (Day-1), Month 6, Month 24 |
|
|
|
| Secondary | Change From Baseline in Mean Daily Insulin Use | Participants were asked to record their daily insulin usage thoroughly and accurately in a diary from 7 days prior to study visit. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | ITT treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | International unit | Baseline (Day-1), Week 2, Week 3, Week 6, Week 8, Week 12, Week 24, Week 36, Week 48, Week 72 and Week 96 |
|
|
|
| Secondary | Change From Baseline in Hemoglobin A1c | Hemoglobin A1C levels were measured at indicated time points. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | ITT treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Percentage of HbA1c | Baseline (Day-1), Month 6, Month 12 and Month 24 |
|
|
|
| Secondary | Absolute Body Weight | Body weight was measured at indicated time points. | ITT treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Kilogram | Day-1, Month 12, Month 18 and Month 24 |
|
|
|
| Secondary | Time-normalized Number of Hypoglycemic and Hyperglycemic Events | As per American Diabetes Association (ADA), hypoglycemia is defined as blood glucose level <= 70 milligram/deciliter (mg/dl) and hyperglycemia is defined as blood glucose level > 250 mg/dL. Hypoglycaemic and hyperglycaemic events will be recorded in a diary whenever they occur, along with the start and stop dates. Mean number of events is defined as the average number of events reported per subject. Normalization is expressed by dividing number of events by length of reporting period in month (1 month = 30 days). | ITT treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Number of events | Up to Month 24 |
|
|
|
| Secondary | Relative Change From Baseline in Percentage (%) in CD4+ Cells | Whole blood samples were collected and analyzed by flow cytometry. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Relative change from Baseline (percentage) was calculated as change from Baseline relative to Baseline in percentage. | Fully treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Percentage | Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14 |
|
|
|
| Secondary | Relative Change From Baseline in Percentage (%) in CD8+ Cells | Whole blood samples were collected and analyzed by flow cytometry. Day1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Relative change from baseline (%) was calculated as change from Baseline relative to Baseline in %. NA indicates that standard deviation could not be calculated for a single participant. | Fully treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Percentage | Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14 |
|
|
|
| Secondary | Change From Baseline in Free CD3 on CD8+ Cells | Whole blood samples were drawn and analyzed by flow cytometry. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. NA indicates that standard deviation could not be calculated for a single participant. | Fully treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Copies per cell | Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14 |
|
|
|
| Secondary | Change From Baseline in Free CD3 on CD4+ Cells | Whole blood samples were drawn and analyzed by flow cytometry. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. NA indicates that standard deviation could not be calculated for a single participant. | Fully treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Copies per cell | Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14 |
|
|
|
| Secondary | Change From Baseline in Bound CD3 Copies on CD4+ Cells | Whole blood samples were drawn and analyzed by flow cytometry. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. NA indicates that standard deviation could not be calculated for a single participant. | Fully treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Copies per cell | Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14 |
|
|
|
| Secondary | Change From Baseline in Bound CD3 Copies on CD8+ Cells | Whole blood samples were drawn and analyzed by flow cytometry. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. NA indicates that standard deviation could not be calculated for a single participant. | Fully treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Copies per cell | Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14 |
|
|
|
| Secondary | Number of Participants With Anti-drug Antibody Binding | Samples were analyzed for the presence of anti-Otelixizumab antibodies using a validated immunoelectrochemiluminescent (ECL) assay. | Safety population | Posted | Number | Participants | Day-1, Month 3 and Month 6 |
|
|
|
| 0 |
| 5 |
| 1 |
| 5 |
| 5 |
| 5 |
| EG001 | Otelixizumab 9 mg | Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days | 0 | 9 | 2 | 9 | 9 | 9 |
| EG002 | Otelixizumab 18 mg | Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days | 0 | 8 | 1 | 8 | 8 | 8 |
| EG003 | Otelixizumab 27 mg | Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days | 0 | 7 | 1 | 7 | 7 | 7 |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Metabolic disorder | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Metabolic disorder | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Gingival recession | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Tongue disorder | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Generalised erythema | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Body tinea | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Gingival abscess | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Application site scab | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Facial pain | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Infusion site reaction | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Nodule | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Electrocardiogram QT Prolonged | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Heart rate irregular | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Repetitive strain injury | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Monocytosis | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
|
| Depressive symptom | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
|
| Intentional self-injury | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Ear disorder | Ear and labyrinth disorders | MedDRA 21.1 | Systematic Assessment |
|
| Motion sickness | Ear and labyrinth disorders | MedDRA 21.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 21.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 21.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Microalbuminuria | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Balanoposthitis | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
|
| Nipple pain | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
|
| Nail operation | Surgical and medical procedures | MedDRA 21.1 | Systematic Assessment |
|
| Wisdom teeth removal | Surgical and medical procedures | MedDRA 21.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 21.1 | 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.
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
|
| Week 6, n=4, 9, 8, 7 |
|
|
| Week 8, n=5, 9, 7, 5 |
|
|
| Week 12, n=4, 9, 8, 6 |
|
|
| Week 24, n=4, 9, 7, 7 |
|
|
| Week 96, n=4, 9, 7, 7 |
|
|
|
| ALT, High, n= 5, 9, 8, 7 |
|
|
| Albumin, Low, n= 5, 9, 8, 7 |
|
|
| Albumin, High, n= 5, 9, 8, 7 |
|
|
| ALP, Low, n= 5, 9, 8, 7 |
|
|
| ALP, High, n= 5, 9, 8, 7 |
|
|
| AST, Low, n= 5, 9, 8, 7 |
|
|
| AST, High, n= 5, 9, 8, 7 |
|
|
| Bilirubin, Low, n= 5, 9, 8, 7 |
|
|
| Bilirubin, High, n= 5, 9, 8, 7 |
|
|
| Calcium, Low, n= 5, 9, 8, 7 |
|
|
| Calcium, High, n= 5, 9, 8, 7 |
|
|
| Chloride, Low, n= 5, 9, 8, 7 |
|
|
| Chloride, High, n= 5, 9, 8, 7 |
|
|
| Creatinine, Low, n= 5, 9, 8, 7 |
|
|
| Creatinine, High, n= 5, 9, 8, 7 |
|
|
| Direct Bilirubin, Low, n= 1, 5, 4, 5 |
|
|
| Direct Bilirubin, High, n= 1, 5, 4, 5 |
|
|
| Glucose, Low, n= 5, 9, 8, 7 |
|
|
| Glucose, High, n= 5, 9, 8, 7 |
|
|
| Potassium, Low, n= 5, 9, 8, 7 |
|
|
| Potassium, High, n= 5, 9, 8, 7 |
|
|
| Protein, Low, n= 5, 9, 8, 7 |
|
|
| Protein, High, n= 5, 9, 8, 7 |
|
|
| Sodium, Low, n= 5, 9, 8, 7 |
|
|
| Sodium, High, n= 5, 9, 8, 7 |
|
|
| Urate, Low, n= 5, 9, 8, 7 |
|
|
| Urate, High, n= 5, 9, 8, 7 |
|
|
| Urea Nitrogen, Low, n= 5, 9, 8, 7 |
|
|
| Urea Nitrogen, High, n= 5, 9, 8, 7 |
|
|
| Basophils, Low, n= 5, 9, 8, 7 |
|
|
| Basophils, High, n= 5, 9, 8, 7 |
|
|
| Eosinophils, Low, n= 5, 9, 8, 7 |
|
|
| Eosinophils, High, n= 5, 9, 8, 7 |
|
|
| MCHC, Low, n= 5, 9, 8, 7 |
|
|
| MCHC, High, n= 5, 9, 8, 7 |
|
|
| MCH, Low, n= 5, 9, 8, 7 |
|
|
| MCH, High, n= 5, 9, 8, 7 |
|
|
| MCV, Low, n= 5, 9, 8, 7 |
|
|
| MCV, High, n= 5, 9, 8, 7 |
|
|
| Erythrocytes, Low, n= 5, 9, 8, 7 |
|
|
| Erythrocytes, High, n= 5, 9, 8, 7 |
|
|
| Hematocrit, Low, n= 5, 9, 8, 7 |
|
|
| Hematocrit, High, n= 5, 9, 8, 7 |
|
|
| Hemoglobin, Low, n= 5, 9, 8, 7 |
|
|
| Hemoglobin, High, n= 5, 9, 8, 7 |
|
|
| Leukocytes, Low, n= 5, 9, 8, 7 |
|
|
| Leukocytes, High, n= 5, 9, 8, 7 |
|
|
| Lymphocytes, Low, n= 5, 9, 8, 7 |
|
|
| Lymphocytes, High, n= 5, 9, 8, 7 |
|
|
| Monocytes, Low, n= 5, 9, 8, 7 |
|
|
| Monocytes, High, n= 5, 9, 8, 7 |
|
|
| Neutrophils, Low, n= 5, 9, 8, 7 |
|
|
| Neutrophils, High, n= 5, 9, 8, 7 |
|
|
| Platelets, Low, n= 5, 9, 8, 7 |
|
|
| Platelets, High, n= 5, 9, 8, 7 |
|
|
| Reticulocytes, Low, n= 1, 3, 4, 4 |
|
|
| Reticulocytes, High, n= 1, 3, 4, 4 |
|
|
| QTc Interval (Fridericia), Increase >60 millisec |
|
| Systolic Blood Pressure, High |
|
| Diastolic Blood Pressure, Low |
|
| Diastolic Blood Pressure, High |
|
| Pulse Rate, Low |
|
| Pulse Rate, High |
|
| Respiratory Rate, Low |
|
| Respiratory Rate, High |
|
| Day 1, 30 minutes, n=8, 8, 6 |
|
|
| Day 1, 1 hour, n=8, 8, 6 |
|
|
| Day 1, 2 hours, n=8, 8, 6 |
|
|
| Day 1, 4 hours, n=7, 8, 6 |
|
|
| Day 1, 6 hours, n=8, 8, 6 |
|
|
| Day 1, 8 hours, n=8, 7, 6 |
|
|
| Day 1, 9 hours, n=7, 8, 6 |
|
|
| Day 1, 16 hours, n=7, 8, 6 |
|
|
| Day 2, Pre-Dose, n=8, 8, 6 |
|
|
| Day 3, Pre-Dose, n=8, 8, 6 |
|
|
| Day 4, Pre-Dose, n=8, 8, 6 |
|
|
| Day 5, Pre-Dose, n=8, 8, 6 |
|
|
| Day 6, Pre-Dose, n=8, 8, 6 |
|
|
| Day 6, 1 hour, n=8, 8, 6 |
|
|
| Day 14, n=7, 8, 5 |
|
|
|
| Month 6, n=5, 8, 8, 7 |
|
|
| Month 12, n=5, 8, 8, 7 |
|
|
| Month 18, n=5, 8, 7, 7 |
|
|
| Month 24, n=4, 7, 7, 7 |
|
|
|
| Month 6, n=5, 8, 8, 7 |
|
|
| Month 12, n=5, 8, 8, 7 |
|
|
| Month 18, n=5, 8, 7, 7 |
|
|
| Month 24, n=4, 7, 7, 7 |
|
|
|
| Month 24, n=4, 5, 7, 7 |
|
|
|
| Month 24, n=4, 5, 7, 7 |
|
|
|
| Month 24, n=4, 4, 6, 6 |
|
|
|
| Week 3, n=5, 8, 8, 7 |
|
|
| Week 6, n=5, 4, 8, 7 |
|
|
| Week 8, n=4, 7, 5, 6 |
|
|
| Week 12, n=4, 8, 8, 7 |
|
|
| Week 24, n=5, 8, 5, 7 |
|
|
| Week 36, n=4, 8, 7, 7 |
|
|
| Week 48, n=5, 8, 8, 7 |
|
|
| Week 72, n=5, 8, 7, 5 |
|
|
| Week 96, n=4, 6, 7, 7 |
|
|
|
| Month 12, n=5, 9, 8, 7 |
|
|
| Month 24, n=4, 9, 7, 7 |
|
|
|
| Month 12, n=5, 9, 8, 7 |
|
|
| Month 18, n=5, 9, 7, 7 |
|
|
| Month 24, n=4, 9, 7, 7 |
|
|
| Hyperglycemia |
|
|
| Day 1, 1 hour, n=5, 7, 8, 6 |
|
|
| Day 1, 2 hours, n=5, 7, 8, 6 |
|
|
| Day 1, 4 hours, n=5, 7, 8, 6 |
|
|
| Day 1, 6 hours, n=5, 7, 8, 6 |
|
|
| Day 1, 8 hours, n=5, 7, 7, 6 |
|
|
| Day 1, 9 hours, n=1, 6, 0, 0 |
|
|
| Day 1, 12 hours, n=4, 0, 7, 6 |
|
|
| Day 1, 16 hours, n=4, 6, 8, 6 |
|
|
| Day 2, n=5, 7, 8, 6 |
|
|
| Day 3, n=5, 7, 8, 6 |
|
|
| Day 4, n=5, 7, 8, 6 |
|
|
| Day 5, n=5, 7, 8, 6 |
|
|
| Day 6, n=5, 7, 8, 6 |
|
|
| Day 6, 1 hour, n=5, 7, 8, 6 |
|
|
| Day 14, n=5, 6, 8, 4 |
|
|
|
| Day 1, 1 hour, n=5, 7, 8, 6 |
|
|
| Day 1, 2 hours, n=5, 7, 8, 6 |
|
|
| Day 1, 4 hours, n=5, 7, 8, 6 |
|
|
| Day 1, 6 hours, n=5, 7, 8, 6 |
|
|
| Day 1, 8 hours, n=5, 7, 7, 6 |
|
|
| Day 1, 9 hours, n=1, 6, 0, 0 |
|
|
| Day 1, 12 hours, n=4, 0, 7, 6 |
|
|
| Day 1, 16 hours, n=4, 6, 8, 6 |
|
|
| Day 2, n=5, 7, 8, 6 |
|
|
| Day 3, n=5, 7, 8, 6 |
|
|
| Day 4, n=5, 7, 8, 6 |
|
|
| Day 5, n=5, 7, 8, 6 |
|
|
| Day 6, n=5, 7, 8, 6 |
|
|
| Day 6, 1 hour, n=5, 7, 8, 6 |
|
|
| Day 14, n=5, 6, 8, 4 |
|
|
|
| Day 1, 1 hour, n=5, 7, 8, 6 |
|
|
| Day 1, 2 hours, n=5, 7, 8, 6 |
|
|
| Day 1, 4 hours, n=5, 7, 8, 6 |
|
|
| Day 1, 6 hours, n=5, 7, 8, 6 |
|
|
| Day 1, 8 hours, n=5, 7, 7, 6 |
|
|
| Day 1, 9 hours, n=1, 6, 0, 0 |
|
|
| Day 1, 12 hours, n=4, 0, 7, 6 |
|
|
| Day 1, 16 hours, n=4, 6, 8, 6 |
|
|
| Day 2, n=5, 7, 8, 6 |
|
|
| Day 3, n=5, 7, 8, 6 |
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| Day 4, n=5, 7, 8, 6 |
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| Day 5, n=5, 7, 8, 6 |
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| Day 6, n=5, 7, 8, 6 |
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| Day 6, 1 hour, n=5, 7, 8, 6 |
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| Day 14, n=5, 6, 8, 4 |
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| Day 1, 1 hour, n=5, 7, 8, 6 |
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| Day 1, 2 hours, n=5, 7, 8, 6 |
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| Day 1, 4 hours, n=5, 7, 8, 6 |
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| Day 1, 6 hours, n=5, 7, 8, 6 |
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| Day 1, 8 hours, n=5, 7, 7, 6 |
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| Day 1, 9 hours, n=1, 6, 0, 0 |
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| Day 1, 12 hours, n=4, 0, 7, 6 |
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| Day 1, 16 hours, n=4, 6, 8, 6 |
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| Day 2, n=5, 7, 8, 6 |
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| Day 3, n=5, 7, 8, 6 |
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| Day 4, n=5, 7, 8, 6 |
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| Day 5, n=5, 7, 8, 6 |
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| Day 6, n=5, 7, 8, 6 |
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| Day 6, 1 hour, n=5, 7, 8, 6 |
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| Day 14, n=5, 6, 8, 4 |
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| Day 1, 1 hour, n=5, 7, 8, 6 |
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| Day 1, 2 hours, n=5, 7, 8, 6 |
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| Day 1, 4 hours, n=5, 7, 8, 6 |
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| Day 1, 6 hours, n=5, 7, 8, 6 |
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| Day 1, 8 hours, n=5, 7, 7, 6 |
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| Day 1, 9 hours, n=1, 6, 0, 0 |
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| Day 1, 12 hours, n=4, 0, 7, 6 |
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| Day 1, 16 hours, n=4, 6, 8, 6 |
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| Day 2, n=5, 7, 8, 6 |
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| Day 3, n=5, 7, 8, 6 |
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| Day 4, n=5, 7, 8, 6 |
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| Day 5, n=5, 7, 8, 6 |
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| Day 6, n=5, 7, 8, 6 |
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| Day 6, 1 hour, n=5, 7, 8, 6 |
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| Day 14, n=5, 6, 8, 4 |
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| Day 1, 1 hour, n=5, 7, 8, 6 |
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| Day 1, 2 hours, n=5, 7, 8, 6 |
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| Day 1, 4 hours, n=5, 7, 8, 6 |
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| Day 1, 6 hours, n=5, 7, 8, 6 |
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| Day 1, 8 hours, n=5, 7, 7, 6 |
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| Day 1, 9 hours, n=1, 6, 0, 0 |
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| Day 1, 12 hours, n=4, 0, 7, 6 |
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| Day 1, 16 hours, n=4, 6, 8, 6 |
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| Day 2, n=5, 7, 8, 6 |
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| Day 3, n=5, 7, 8, 6 |
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| Day 4, n=5, 7, 8, 6 |
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| Day 5, n=5, 7, 8, 6 |
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| Day 6, n=5, 7, 8, 6 |
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| Day 6, 1 hour, n=5, 7, 8, 6 |
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| Day 14, n=5, 6, 8, 4 |
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| Day-1, Positive |
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| Month 3, Negative |
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| Month 3, Positive |
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| Month 3, Newly Positive |
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| Month 3, Negative who were Positive previously |
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| Month 6, Negative |
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| Month 6, Positive |
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| Month 6, Newly Positive |
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| Month 6, Negative who were Positive previously |
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